115 results on '"Koks, Carolien A. M."'
Search Results
2. Hysteroscopy before in-vitro fertilisation (inSIGHT): a multicentre, randomised controlled trial
- Author
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Smit, Janine G, Kasius, Jenneke C, Eijkemans, Marinus J C, Koks, Carolien A M, van Golde, Ronald, Nap, Annemiek W, Scheffer, Gabrielle J, Manger, Petra A P, Hoek, Annemieke, Schoot, Benedictus C, van Heusden, Arne M, Kuchenbecker, Walter K H, Perquin, Denise A M, Fleischer, Kathrin, Kaaijk, Eugenie M, Sluijmer, Alexander, Friederich, Jaap, Dykgraaf, Ramon H M, van Hooff, Marcel, Louwe, Leonie A, Kwee, Janet, de Koning, Corry H, Janssen, Ineke C A H, Mol, Femke, Mol, Ben W J, Broekmans, Frank J M, and Torrance, Helen L
- Published
- 2016
- Full Text
- View/download PDF
3. Individualized versus standard FSH dosing in women starting IVF/ICSI: an RCT. Part 1: The predicted poor responder
- Author
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van Tilborg, Theodora C, Torrance, Helen L, Oudshoorn, Simone C, Eijkemans, Marinus J C, Koks, Carolien A M, Verhoeve, Harold R, Nap, Annemiek W, Scheffer, Gabrielle J, Manger, A Petra, Schoot, Benedictus C, Sluijmer, Alexander V, Verhoeff, Arie, Groen, Henk, Laven, Joop S E, Mol, Ben Willem J, Broekmans, Frank J M, van Tilborg, Theodora C, Oudshoorn, Simone C, Eijkemans, Marinus J C, Mochtar, Monique H, Koks, Carolien A M, van Golde, Ron J T, Verhoeve, Harold R, Nap, Annemiek W, Scheffer, Gabrielle J, Manger, A Petra, Hoek, Annemieke, Schoot, Bendictus C, Oosterhuis, G Jur E, Kuchenbecker, Walter K H, Fleischer, Kathrin, de Bruin, Jan Peter, Sluijmer, Alexander V, Friederich, Jaap, Verhoeff, Arie, van Hooff, Marcel H A, van Santbrink, Evert J P, Brinkhuis, Egbert A, Smeenk, Jesper M J, Kwee, Janet, de Koning, Corry H, Groen, Henk, van Wely, Madelon, Lambalk, Cornelis B, Laven, Joop S E, Mol, Ben Willem J, Broekmans, Frank J M, and Torrance, Helen L
- Published
- 2017
- Full Text
- View/download PDF
4. Salpingotomy versus salpingectomy in women with tubal pregnancy (ESEP study): an open-label, multicentre, randomised controlled trial
- Author
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Mol, Femke, van Mello, Norah M, Strandell, Annika, Strandell, Karin, Jurkovic, Davor, Ross, Jackie, Barnhart, Kurt T, Yalcinkaya, Tamer M, Verhoeve, Harold R, Graziosi, Giuseppe C M, Koks, Carolien A M, Klinte, Ingmar, Hogström, Lars, Janssen, Ineke C A H, Kragt, Harry, Hoek, Annemieke, Trimbos-Kemper, Trudy C M, Broekmans, Frank J M, Willemsen, Wim N P, Ankum, Willem M, Mol, Ben W, van Wely, Madelon, van der Veen, Fulco, and Hajenius, Petra J
- Published
- 2014
- Full Text
- View/download PDF
5. Individualized versus standard FSH dosing in women starting IVF/ICSI: an RCT. Part 2: The predicted hyper responder
- Author
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Oudshoorn, Simone C, van Tilborg, Theodora C, Eijkemans, Marinus J C, Oosterhuis, G Jur E, Friederich, Jaap, van Hooff, Marcel H A, van Santbrink, Evert J P, Brinkhuis, Egbert A, Smeenk, Jesper M J, Kwee, Janet, de Koning, Corry H, Groen, Henk, Lambalk, Cornelis B, Mol, Ben Willem J, Broekmans, Frank J M, Torrance, Helen L, van Tilborg, Theodora C, Oudshoorn, Simone C, Eijkemans, Marinus J C, Mochtar, Monique H, Koks, Carolien A M, van Golde, Ron J T, Verhoeve, Harold R, Nap, Annemiek W, Scheffer, Gabrielle J, Manger, A Petra, Hoek, Annemieke, Schoot, Bendictus C, Oosterhuis, G Jur E, Kuchenbecker, Walter K H, Fleischer, Kathrin, de Bruin, Jan Peter, Sluijmer, Alexander V, Friederich, Jaap, Verhoeff, Arie, van Hooff, Marcel H A, van Santbrink, Evert J P, Brinkhuis, Egbert A, Smeenk, Jesper M J, Kwee, Janet, de Koning, Corry H, Groen, Henk, van Wely, Madelon, Lambalk, Cornelis B, Laven, Joop S E, Mol, Ben Willem J, Broekmans, Frank J M, and Torrance, Helen L
- Published
- 2017
- Full Text
- View/download PDF
6. Individualized FSH dosing based on ovarian reserve testing in women starting IVF/ICSI: a multicentre trial and cost-effectiveness analysis
- Author
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van Tilborg, Theodora C, Oudshoorn, Simone C, Eijkemans, Marinus J C, Mochtar, Monique H, van Golde, Ron J T, Hoek, Annemieke, Kuchenbecker, Walter K H, Fleischer, Kathrin, de Bruin, Jan Peter, Groen, Henk, van Wely, Madelon, Lambalk, Cornelis B, Laven, Joop S E, Mol, Ben Willem J, Broekmans, Frank J M, Torrance, Helen L, van Tilborg, Theodora C, Oudshoorn, Simone C, Eijkemans, Marinus J C, Mochtar, Monique H, Koks, Carolien A M, van Golde, Ron J T, Verhoeve, Harold R, Nap, Annemiek W, Scheffer, Gabrielle J, Manger, A Petra, Hoek, Annemieke, Schoot, Bendictus C, Oosterhuis, G Jur E., Kuchenbecker, Walter K H, Fleischer, Kathrin, de Bruin, Jan Peter, Sluijmer, Alexander V, Friederich, Jaap, Verhoeff, Arie, van Hooff, Marcel H A, van Santbrink, Evert J P, Brinkhuis, Egbert A, Smeenk, Jesper M J, Kwee, Janet, de Koning, Corry H, Groen, Henk, van Wely, Madelon, Lambalk, Cornelis B, Laven, Joop S E, Mol, Ben Willem J, Broekmans, Frank J M, and Torrance, Helen L
- Published
- 2017
- Full Text
- View/download PDF
7. What is the fertility-enhancing effect of tubal flushing? A hypothesis article
- Author
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Roest, Inez, primary, Hajiyavand, Amir M., additional, Bongers, Marlies Y., additional, Mijatovic, Velja, additional, Mol, Ben Willem J., additional, Koks, Carolien A. M., additional, and Dearn, Karl D., additional
- Published
- 2022
- Full Text
- View/download PDF
8. Perioperative findings and complications in Essure® removal surgery
- Author
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Arts-assistenten DV&B, DV&B-MT-Medisch, Horsten, Dieuwertje L, van Gastel, Daniëlle M, Maassen, Liselotte W, Koks, Carolien A M, Veersema, Sebastiaan, Bongers, Marlies Y, Arts-assistenten DV&B, DV&B-MT-Medisch, Horsten, Dieuwertje L, van Gastel, Daniëlle M, Maassen, Liselotte W, Koks, Carolien A M, Veersema, Sebastiaan, and Bongers, Marlies Y
- Published
- 2021
9. Challenges in Removing the Essure® Device
- Author
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van Gastel, Daniëlle M., Maassen, Liselotte W., Koks, Carolien A. M., Veersema, Sebastiaan, and Bongers, Marlies Y.
- Subjects
Article Subject - Abstract
We present a case about Essure® removal surgery in which the third markers of the device have torn off. The woman needed a second surgery for complete removal of the devices. Fluoroscopy during surgery is a good method to visualize the lost fragments. With fluoroscopy, a hysterectomy is not needed for complete removal. It is important to understand the structure of the device and to be aware of the four radiopaque markers during surgery and their removal.
- Published
- 2020
- Full Text
- View/download PDF
10. Challenges in Removing the Essure® Device
- Author
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Arts-assistenten DV&B, DV&B-MT-Medisch, Child Health, van Gastel, Daniëlle M, Maassen, Liselotte W, Koks, Carolien A M, Veersema, Sebastiaan, Bongers, Marlies Y, Arts-assistenten DV&B, DV&B-MT-Medisch, Child Health, van Gastel, Daniëlle M, Maassen, Liselotte W, Koks, Carolien A M, Veersema, Sebastiaan, and Bongers, Marlies Y
- Published
- 2020
11. Do female age and body weight modify the effect of individualized FSH dosing in IVF/ICSI treatment? A secondary analysis of the OPTIMIST trial
- Author
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Leijdekkers, Jori A., van Tilborg, Theodora C., Torrance, Helen L., Oudshoorn, Simone C., Brinkhuis, Egbert A., Koks, Carolien A. M., Lambalk, Cornelis B., de Bruin, Jan Peter, Fleischer, Kathrin, Mochtar, Monique H., Kuchenbecker, Walter K. H., Laven, Joop S. E., Mol, Ben Willem J., Broekmans, Frank J. M., Eijkemans, Marinus J. C., van Golde, Ron J. T., Verhoeve, Harold R., Nap, Annemiek W., Scheffer, Gabrielle J., Manger, A. Petra, Hoek, Annemieke, Schoot, Bendictus C., Oosterhuis, G. Jur E., Sluijmer, Alexander V., Friederich, Jaap, Verhoeff, Arie, van Hooff, Marcel H. A., van Santbrink, Evert J. P., Smeenk, Jesper M. J., Kwee, Janet, de Koning, Corry H., Groen, Henk, van Wely, Madelon, Graduate School, Center for Reproductive Medicine, Amsterdam Reproduction & Development (AR&D), APH - Personalized Medicine, APH - Methodology, Obstetrics and gynaecology, ACS - Atherosclerosis & ischemic syndromes, Amsterdam Neuroscience - Cellular & Molecular Mechanisms, Cardiology, Obstetrics & Gynecology, Reproductive Origins of Adult Health and Disease (ROAHD), and Value, Affordability and Sustainability (VALUE)
- Subjects
antral follicle count ,in vitro fertilization/intracytoplasmic sperm injection ,Adult ,medicine.medical_specialty ,medicine.medical_treatment ,Ovarian hyperstimulation syndrome ,intracytoplasmic sperm injection ,Fertilization in Vitro ,Logistic regression ,Intracytoplasmic sperm injection ,Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18] ,All institutes and research themes of the Radboud University Medical Center ,individualized follicle-stimulating hormone dosing ,Obstetrics and Gynaecology ,ovarian hyperstimulation syndrome ,Journal Article ,Medicine ,Humans ,Dosing ,Prospective Studies ,Sperm Injections, Intracytoplasmic ,Netherlands ,In vitro fertilisation ,business.industry ,Obstetrics ,Body Weight ,Age Factors ,Obstetrics and Gynecology ,General Medicine ,Antral follicle ,medicine.disease ,female age ,Female ,Follicle Stimulating Hormone ,business ,Live birth ,in vitro fertilization ,effect modification ,Live Birth ,Hormone - Abstract
Introduction: The OPTIMIST trial revealed that for women starting in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) treatment, no substantial differences exist in first cycle and cumulative live birth rates between an antral follicle count (AFC)-based individualized follicle-stimulating hormone (FSH) dose and a standard dose. Female age and body weight have been suggested to cause heterogeneity in the effect of FSH dose individualization. The objective of the current study is to evaluate whether these patient characteristics modify the effect of AFC-based individualized FSH dosing in IVF/ICSI treatment.Material and methods: A secondary data-analysis of the OPTIMIST trial. Women initiating IVF/ICSI treatment were classified as predicted poor (AFC 0-7), suboptimal (AFC 8-10) or hyper responders (AFC >15), and randomly allocated to a standard FSH dose (150 IU/d) or an individualized FSH dose (450, 225 or 100 IU/d for predicted poor, suboptimal and hyper responders, respectively). In each predicted response category, logistic regression models with interaction terms were used to evaluate the presence of effect modification. The first cycle was analyzed, and the primary outcomes were first complete cycle live birth rate (including fresh plus frozen-thawed embryo transfers) and ovarian hyperstimulation syndrome (OHSS) risks.Results: No effect modification was revealed in the predicted poor (n = 234) and suboptimal (n = 277) responders. In the predicted hyper responders (n = 521), the effect of the individualized FSH dose on the first cycle live birth rate was modified by female age (P = 0.02) and the effect on OHSS risks was modified by body weight (P = 0.02). A dose reduction from 150 to 100 IU/d generally decreased the OHSS risks in predicted hyper responders, but also reduced the chance of a live birth in young women, and had no beneficial impact on OHSS risks in women with a relatively low body weight.Conclusions: In women with a predicted hyper response undergoing IVF/ICSI treatment, female age and body weight seem to modify the effect of FSH dose individualization. Although a reduced FSH starting dose generally decreases the OHSS risks, it may also reduce the chance of a live birth, specifically for young women. Future studies could consider these findings when investigating the optimal approach to reduce OHSS risks while maintaining the probability of a live birth for predicted hyper responders in IVF/ICSI treatment.
- Published
- 2018
12. Gonadotrophins versus clomifene citrate with or without intrauterine insemination in women with normogonadotropic anovulation and clomifene failure (M-OVIN) : A randomised, two-by-two factorial trial
- Author
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Weiss, Nienke S., Nahuis, Marleen J., Bordewijk, Esmee, Oosterhuis, Jurjen G E, Smeenk, Jesper M J, Hoek, Annemieke, Broekmans, Frank J.M., Fleischer, Kathrin, de Bruin, Jan Peter, Kaaijk, Eugenie M, Laven, Joop S E, Hendriks, Dave J., Gerards, Marie H., van Rooij, Ilse A J, Bourdrez, Petra, Gianotten, Judith, Koks, Carolien A M, Lambalk, Cornelis B., Hompes, Peter G A, van der Veen, Fulco, Mol, Ben Willem J., van Wely, Madelon, Weiss, Nienke S., Nahuis, Marleen J., Bordewijk, Esmee, Oosterhuis, Jurjen G E, Smeenk, Jesper M J, Hoek, Annemieke, Broekmans, Frank J.M., Fleischer, Kathrin, de Bruin, Jan Peter, Kaaijk, Eugenie M, Laven, Joop S E, Hendriks, Dave J., Gerards, Marie H., van Rooij, Ilse A J, Bourdrez, Petra, Gianotten, Judith, Koks, Carolien A M, Lambalk, Cornelis B., Hompes, Peter G A, van der Veen, Fulco, Mol, Ben Willem J., and van Wely, Madelon
- Published
- 2018
13. Gonadotrophins versus clomifene citrate with or without intrauterine insemination in women with normogonadotropic anovulation and clomifene failure (M-OVIN): A randomised, two-by-two factorial trial
- Author
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UMC Utrecht, MS VPG/Gynaecologie, Child Health, Circulatory Health, Weiss, Nienke S., Nahuis, Marleen J., Bordewijk, Esmee, Oosterhuis, Jurjen G E, Smeenk, Jesper M J, Hoek, Annemieke, Broekmans, Frank J.M., Fleischer, Kathrin, de Bruin, Jan Peter, Kaaijk, Eugenie M, Laven, Joop S E, Hendriks, Dave J., Gerards, Marie H., van Rooij, Ilse A J, Bourdrez, Petra, Gianotten, Judith, Koks, Carolien A M, Lambalk, Cornelis B., Hompes, Peter G A, van der Veen, Fulco, Mol, Ben Willem J., van Wely, Madelon, UMC Utrecht, MS VPG/Gynaecologie, Child Health, Circulatory Health, Weiss, Nienke S., Nahuis, Marleen J., Bordewijk, Esmee, Oosterhuis, Jurjen G E, Smeenk, Jesper M J, Hoek, Annemieke, Broekmans, Frank J.M., Fleischer, Kathrin, de Bruin, Jan Peter, Kaaijk, Eugenie M, Laven, Joop S E, Hendriks, Dave J., Gerards, Marie H., van Rooij, Ilse A J, Bourdrez, Petra, Gianotten, Judith, Koks, Carolien A M, Lambalk, Cornelis B., Hompes, Peter G A, van der Veen, Fulco, Mol, Ben Willem J., and van Wely, Madelon
- Published
- 2018
14. Cost-effectiveness analysis of lifestyle intervention in obese infertile women
- Author
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Van Oers, Anne M., Mutsaerts, Meike A Q, Burggraaff, Jan M., Kuchenbecker, Walter K H, Perquin, Denise A M, Koks, Carolien A M, van Golde, R., Kaaijk, Eugenie M, Schierbeek, Jaap M., Klijn, Nicole F., Van Kasteren, Yvonne M., Land, Jolande A, Mol, B. W J, Hoek, A., Groen, H., Oosterhuis, G. J.E., Broekmans, F. J., Vogel, Niels E A, Lambalk, Cornelis B., Verberg, Marieke F G, Mercelina, Patricia E A M, van der Veen, F, Nap, Annemiek W., Gondrie, Ed T C M, Mulder, Robert J A B, Bruin, Jacob P, Reproductive Origins of Adult Health and Disease (ROAHD), Methods in Medicines evaluation & Outcomes research (M2O), Value, Affordability and Sustainability (VALUE), Obstetrics and gynaecology, Amsterdam Reproduction & Development (AR&D), ACS - Atherosclerosis & ischemic syndromes, Plastic, Reconstructive and Hand Surgery, Afdeling Onderwijs FHML, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), and RS: GROW - R4 - Reproductive and Perinatal Medicine
- Subjects
Male ,obesity ,Cost effectiveness ,Cost-Benefit Analysis ,Overweight ,Body Mass Index ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,law ,Obstetrics and Gynaecology ,030212 general & internal medicine ,Birth Rate ,Netherlands ,Family Characteristics ,OUTCOMES ,030219 obstetrics & reproductive medicine ,Obstetrics ,SUBFERTILE ,Rehabilitation ,Obstetrics and Gynecology ,Cost-effectiveness analysis ,scenario analysis ,Weight Reduction Programs ,PREGNANCY ,Female ,medicine.symptom ,Live birth ,infertility ,Infertility, Female ,Adult ,Infertility ,medicine.medical_specialty ,Patient Dropouts ,Reproductive medicine ,WEIGHT-LOSS ,Fertilization in Vitro ,Direct Service Costs ,03 medical and health sciences ,DELIVERY ,Ovulation Induction ,Intervention (counseling) ,Weight Loss ,medicine ,Journal Article ,Humans ,Infant Health ,FERTILITY TREATMENT ,Healthy Lifestyle ,cost-effectiveness ,Infertility, Male ,COUPLES ,Cryopreservation ,OVERWEIGHT ,business.industry ,lifestyle intervention ,LIVE BIRTH ,Embryo Transfer ,medicine.disease ,BODY-MASS INDEX ,Reproductive Medicine ,anovulation ,Physical therapy ,Lost to Follow-Up ,business ,Follow-Up Studies - Abstract
STUDY QUESTION What is the cost-effectiveness of lifestyle intervention preceding infertility treatment in obese infertile women? SUMMARY ANSWER Lifestyle intervention preceding infertility treatment as compared to prompt infertility treatment in obese infertile women is not a cost-effective strategy in terms of healthy live birth rate within 24 months after randomization, but is more likely to be cost-effective using a longer follow-up period and live birth rate as endpoint. WHAT IS KNOWN ALREADY In infertile couples, obesity decreases conception chances. We previously showed that lifestyle intervention prior to infertility treatment in obese infertile women did not increase the healthy singleton vaginal live birth rate at term, but increased natural conceptions, especially in anovulatory women. Cost-effectiveness analyses could provide relevant additional information to guide decisions regarding offering a lifestyle intervention to obese infertile women. STUDY DESIGN, SIZE, DURATION The cost-effectiveness of lifestyle intervention preceding infertility treatment compared to prompt infertility treatment was evaluated based on data of a previous RCT, the LIFEstyle study. The primary outcome for effectiveness was the vaginal birth of a healthy singleton at term within 24 months after randomization (the healthy live birth rate). The economic evaluation was performed from a hospital perspective and included direct medical costs of the lifestyle intervention, infertility treatments, medication and pregnancy in the intervention and control group. In addition, we performed exploratory cost-effectiveness analyses of scenarios with additional effectiveness outcomes (overall live birth within 24 months and overall live birth conceived within 24 months) and of subgroups, i.e. of ovulatory and anovulatory women, women
- Published
- 2017
15. Editorial comment: Hysteroscopy Before In-Vitro Fertilisation (inSIGHT): A Multicentre, Randomised Controlled Trial (Lancet 2016;387:2622–2629)
- Author
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Smit, Janine G., Kasius, Jenneke C., Eijkemans, Marinus J. C., Koks, Carolien A. M., van Golde, Ron, Nap, Annemiek W., Scheffer, Gabrielle J., Manger, Petra A. P., Hoek, Annemieke, Schoot, Benedictus C., van Heusden, Arne M., Kuchenbecker, Walter K. H., Perquin, Denise A. M., Fleischer, Kathrin, Kaaijk, Eugenie M., Sluijmer, Alexander, Friederich, Jaap, Dykgraaf, Ramon H. M., van Hooff, Marcel, Louwe, Leonie A., Kwee, Janet, de Koning, Corry H., Janssen, Ineke C. A. H., Mol, Femke, Mol, Ben W. J., Broekmans, Frank J. M., Torrance, Helen L., Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), and RS: GROW - R4 - Reproductive and Perinatal Medicine
- Abstract
Since the first successful live birth after in vitro fertilization (IVF) was reported in 1978, more than 5 million children have been born with the help of this and intracytoplasmic sperm injection (ICSI) procedures. However, only approximately 25% to 30% of cycles of IVF and ICSI lead to the birth of a child. The reasons for implantation failure are poorly understood. One major cause of implantation failure is abnormalities of the uterine cavity such as polyps, myoma, and adhesions. Hysteroscopy has been generally regarded as the standard procedure to detect these uterine abnormalities. It is thought to improve pregnancy rates in women scheduled for IVF by detection and surgical removal of uterine cavity abnormalities, dilatation of the cervical canal, or induction of inflammatory reactions in the endometriumby the procedure itself. Hysteroscopy is often performed routinely in infertile women scheduled for their first IVF cycle. However, there are no data from well-designed randomized controlled trials to support this practice. The inSIGHT trial is a pragmatic multicenter randomized clinical trial designed to determine whether routine hysteroscopy before the first IVF treatment cycle increases the live birth rate. The trial was conducted in 7 university hospitals and 15 large general hospitals in the Netherlands. Women eligible for the trial were infertile, scheduled to start their first IVF or ICSI treatment, had no previous hysteroscopy, and had a normal transvaginal ultrasound of the uterine cavity. Subjects were randomly assigned in a 1: 1 ratio to hysteroscopy with treatment of detected intracavitary abnormalities before starting IVF followed by IVF (hysteroscopy group) or to immediate start of IVF treatment (immediate IVF group). Web-based randomization was done with a variable block size to allocate patients to groups and was stratified by center. The doctors, outcome assessors, and participants were not masked to the assigned group. The primary study outcome was an ongoing pregnancy (detection of a fetal heartbeat at > 12weeks of gestation) within 18 months of randomization and a live birth. Analysis was done according to intention to treat. Between May 25, 2011, and August 27, 2013, 750 women were randomized: 373 to the hysteroscopy group and 377 to the immediate IVF group. A live birth occurred during the trial period in 209 (57%) of 369 women in the hysteroscopy group and 200 (54%) of 373 in the immediate IVF group; the relative riskwas 1.06, with a 95% confidence interval of 0.93 to 1.20; P = 0.41. These findings demonstrate that hysteroscopy does not improve live birth rates in infertile women scheduled for their first IVF cycle, who have a normal transvaginal ultrasound of the uterine cavity. Therefore, routine hysteroscopy should not be performed in women with a normal transvaginal ultrasound.
- Published
- 2016
16. Challenges in Removing the Essure® Device.
- Author
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van Gastel, Daniëlle M., Maassen, Liselotte W., Koks, Carolien A. M., Veersema, Sebastiaan, and Bongers, Marlies Y.
- Subjects
HYSTERECTOMY ,SURGERY - Abstract
We present a case about Essure
® removal surgery in which the third markers of the device have torn off. The woman needed a second surgery for complete removal of the devices. Fluoroscopy during surgery is a good method to visualize the lost fragments. With fluoroscopy, a hysterectomy is not needed for complete removal. It is important to understand the structure of the device and to be aware of the four radiopaque markers during surgery and their removal. [ABSTRACT FROM AUTHOR]- Published
- 2020
- Full Text
- View/download PDF
17. Do female age and body weight modify the effect of individualized FSH dosing in IVF/ICSI treatment? A secondary analysis of the OPTIMIST trial.
- Author
-
Leijdekkers, Jori A., van Tilborg, Theodora C., Torrance, Helen L., Oudshoorn, Simone C., Brinkhuis, Egbert A., Koks, Carolien A. M., Lambalk, Cornelis B., de Bruin, Jan Peter, Fleischer, Kathrin, Mochtar, Monique H., Kuchenbecker, Walter K. H., Laven, Joop S. E., Mol, Ben Willem J., Broekmans, Frank J. M., Eijkemans, Marinus J. C., van Golde, Ron J. T., Verhoeve, Harold R., Nap, Annemiek W., Scheffer, Gabrielle J., and Manger, A. Petra
- Subjects
BODY weight ,CHILDBIRTH ,OVARIAN hyperstimulation syndrome ,SECONDARY analysis ,BIRTH rate - Abstract
Introduction: The OPTIMIST trial revealed that for women starting in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) treatment, no substantial differences exist in first cycle and cumulative live birth rates between an antral follicle count (AFC)-based individualized follicle-stimulating hormone (FSH) dose and a standard dose. Female age and body weight have been suggested to cause heterogeneity in the effect of FSH dose individualization. The objective of the current study is to evaluate whether these patient characteristics modify the effect of AFC-based individualized FSH dosing in IVF/ICSI treatment.Material and Methods: A secondary data-analysis of the OPTIMIST trial. Women initiating IVF/ICSI treatment were classified as predicted poor (AFC 0-7), suboptimal (AFC 8-10) or hyper responders (AFC >15), and randomly allocated to a standard FSH dose (150 IU/d) or an individualized FSH dose (450, 225 or 100 IU/d for predicted poor, suboptimal and hyper responders, respectively). In each predicted response category, logistic regression models with interaction terms were used to evaluate the presence of effect modification. The first cycle was analyzed, and the primary outcomes were first complete cycle live birth rate (including fresh plus frozen-thawed embryo transfers) and ovarian hyperstimulation syndrome (OHSS) risks.Results: No effect modification was revealed in the predicted poor (n = 234) and suboptimal (n = 277) responders. In the predicted hyper responders (n = 521), the effect of the individualized FSH dose on the first cycle live birth rate was modified by female age (P = 0.02) and the effect on OHSS risks was modified by body weight (P = 0.02). A dose reduction from 150 to 100 IU/d generally decreased the OHSS risks in predicted hyper responders, but also reduced the chance of a live birth in young women, and had no beneficial impact on OHSS risks in women with a relatively low body weight.Conclusions: In women with a predicted hyper response undergoing IVF/ICSI treatment, female age and body weight seem to modify the effect of FSH dose individualization. Although a reduced FSH starting dose generally decreases the OHSS risks, it may also reduce the chance of a live birth, specifically for young women. Future studies could consider these findings when investigating the optimal approach to reduce OHSS risks while maintaining the probability of a live birth for predicted hyper responders in IVF/ICSI treatment. [ABSTRACT FROM AUTHOR]- Published
- 2019
- Full Text
- View/download PDF
18. The SUPER study : Protocol for a randomised controlled trial comparing follicle-stimulating hormone and clomiphene citrate for ovarian stimulation in intrauterine insemination
- Author
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Danhof, Nora A, Wely, M., Koks, Carolien A M, Gianotten, J., Bruin, Jacob P, Cohlen, Ben J., Van Der Ham, David P., Klijn, Nicole F., van Hooff, M.H.A., Broekmans, F. J.M., Fleischer, K., Janssen, Ineke C A H, Rijn Van Weert, J. M., van Disseldorp, J., Twisk, M., Traas, M.A.F., Verberg, Marieke F G, Pelinck, M. J., Visser, J., Perquin, Denise A M, Boks, D. E.S., Verhoeve, H. R., Van Heteren, C. F., Mol, B. W J, Repping, S., van der Veen, F, Mochtar, M.H., Danhof, Nora A, Wely, M., Koks, Carolien A M, Gianotten, J., Bruin, Jacob P, Cohlen, Ben J., Van Der Ham, David P., Klijn, Nicole F., van Hooff, M.H.A., Broekmans, F. J.M., Fleischer, K., Janssen, Ineke C A H, Rijn Van Weert, J. M., van Disseldorp, J., Twisk, M., Traas, M.A.F., Verberg, Marieke F G, Pelinck, M. J., Visser, J., Perquin, Denise A M, Boks, D. E.S., Verhoeve, H. R., Van Heteren, C. F., Mol, B. W J, Repping, S., van der Veen, F, and Mochtar, M.H.
- Published
- 2017
19. Cost-effectiveness analysis of lifestyle intervention in obese infertile women
- Author
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MS VPG/Gynaecologie, Circulatory Health, Child Health, Van Oers, Anne M., Mutsaerts, Meike A Q, Burggraaff, Jan M., Kuchenbecker, Walter K H, Perquin, Denise A M, Koks, Carolien A M, van Golde, R., Kaaijk, Eugenie M, Schierbeek, Jaap M., Klijn, Nicole F., Van Kasteren, Yvonne M., Land, Jolande A, Mol, B. W J, Hoek, A., Groen, H., Oosterhuis, G. J.E., Broekmans, F. J., Vogel, Niels E A, Lambalk, Cornelis B., Verberg, Marieke F G, Mercelina, Patricia E A M, van der Veen, F, Nap, Annemiek W., Gondrie, Ed T C M, Mulder, Robert J A B, Bruin, Jacob P, behalf of the LIFEstyle study group, MS VPG/Gynaecologie, Circulatory Health, Child Health, Van Oers, Anne M., Mutsaerts, Meike A Q, Burggraaff, Jan M., Kuchenbecker, Walter K H, Perquin, Denise A M, Koks, Carolien A M, van Golde, R., Kaaijk, Eugenie M, Schierbeek, Jaap M., Klijn, Nicole F., Van Kasteren, Yvonne M., Land, Jolande A, Mol, B. W J, Hoek, A., Groen, H., Oosterhuis, G. J.E., Broekmans, F. J., Vogel, Niels E A, Lambalk, Cornelis B., Verberg, Marieke F G, Mercelina, Patricia E A M, van der Veen, F, Nap, Annemiek W., Gondrie, Ed T C M, Mulder, Robert J A B, Bruin, Jacob P, and behalf of the LIFEstyle study group
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- 2017
20. The SUPER study: Protocol for a randomised controlled trial comparing follicle-stimulating hormone and clomiphene citrate for ovarian stimulation in intrauterine insemination
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Leiding Zorg VPG/Gynaecologie, UMC Utrecht, Circulatory Health, Child Health, Danhof, Nora A, Wely, M., Koks, Carolien A M, Gianotten, J., Bruin, Jacob P, Cohlen, Ben J., Van Der Ham, David P., Klijn, Nicole F., van Hooff, M.H.A., Broekmans, F. J.M., Fleischer, K., Janssen, Ineke C A H, Rijn Van Weert, J. M., van Disseldorp, J., Twisk, M., Traas, M.A.F., Verberg, Marieke F G, Pelinck, M. J., Visser, J., Perquin, Denise A M, Boks, D. E.S., Verhoeve, H. R., Van Heteren, C. F., Mol, B. W J, Repping, S., van der Veen, F, Mochtar, M.H., Leiding Zorg VPG/Gynaecologie, UMC Utrecht, Circulatory Health, Child Health, Danhof, Nora A, Wely, M., Koks, Carolien A M, Gianotten, J., Bruin, Jacob P, Cohlen, Ben J., Van Der Ham, David P., Klijn, Nicole F., van Hooff, M.H.A., Broekmans, F. J.M., Fleischer, K., Janssen, Ineke C A H, Rijn Van Weert, J. M., van Disseldorp, J., Twisk, M., Traas, M.A.F., Verberg, Marieke F G, Pelinck, M. J., Visser, J., Perquin, Denise A M, Boks, D. E.S., Verhoeve, H. R., Van Heteren, C. F., Mol, B. W J, Repping, S., van der Veen, F, and Mochtar, M.H.
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- 2017
21. Cost-effectiveness of salpingotomy and salpingectomy in women with tubal pregnancy (a randomized controlled trial)
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Broekmans, FJM, Mol, F., Mello, N.M., Strandell, Annika, Strandell, Karin, Jurkovic, Davor, Ross, Jackie, Barnhart, K., Yalcinkaya, Tamer, Verhoeve, H.R., Graziosi, G.C.M., Koks, Carolien A M, Klinte, Ingmar, Hogstrom, Lars, Janssen, Ineke, Kragt, Harry, Hoek, Annemieke, Trimbos-Kemper, Trudy, Willemsen, Wim, Ankum, W.M., Mol, Benwillem, Wely, M., van der Veen, Fulco, Hajenius, Petra J, Reproductive Origins of Adult Health and Disease (ROAHD), ARD - Amsterdam Reproduction and Development, Center for Reproductive Medicine, Obstetrics and Gynaecology, Other departments, Other Research, APH - Amsterdam Public Health, Obstetrics and gynaecology, Amsterdam Reproduction & Development (AR&D), VU University medical center, Division 1, Plastic, Reconstructive and Hand Surgery, and Pediatric surgery
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Adult ,medicine.medical_specialty ,Cost effectiveness ,Cost-Benefit Analysis ,medicine.medical_treatment ,media_common.quotation_subject ,laparoscopy ,Fertility ,Research Support ,law.invention ,surgery ,Salpingectomy ,Postoperative Complications ,Randomized controlled trial ,Pregnancy ,law ,Journal Article ,medicine ,Humans ,Comparative Study ,Non-U.S. Gov't ,Laparoscopy ,Salpingostomy ,cost-effectiveness ,media_common ,medicine.diagnostic_test ,Ectopic pregnancy ,Obstetrics ,business.industry ,Research Support, Non-U.S. Gov't ,Rehabilitation ,Obstetrics and Gynecology ,medicine.disease ,Confidence interval ,ECTOPIC PREGNANCY ,Multicenter Study ,Reproductive Medicine ,Randomized Controlled Trial ,ectopic pregnancy ,Female ,Pregnancy, Tubal ,business - Abstract
STUDY QUESTION: Is salpingotomy cost effective compared with salpingectomy in women with tubal pregnancy and a healthy contralateral tube?SUMMARY ANSWER: Salpingotomy is not cost effective over salpingectomy as a surgical procedure for tubal pregnancy, as its costs are higher without a better ongoing pregnancy rate while risks of persistent trophoblast are higher.WHAT IS KNOWN ALREADY: Women with a tubal pregnancy treated by salpingotomy or salpingectomy in the presence of a healthy contralateral tube have comparable ongoing pregnancy rates by natural conception. Salpingotomy bears the risk of persistent trophoblast necessitating additional medical or surgical treatment. Repeat ectopic pregnancy occurs slightly more often after salpingotomy compared with salpingectomy. Both consequences imply potentially higher costs after salpingotomy.STUDY DESIGN, SIZE, DURATION: We performed an economic evaluation of salpingotomy compared with salpingectomy in an international multicentre randomized controlled trial in women with a tubal pregnancy and a healthy contralateral tube. Between 24 September 2004 and 29 November 2011, women were allocated to salpingotomy (n = 215) or salpingectomy (n = 231). Fertility follow-up was done up to 36 months post-operatively.PARTICIPANTS/MATERIALS, SETTINGS, METHODS: We performed a cost-effectiveness analysis from a hospital perspective. We compared the direct medical costs of salpingotomy and salpingectomy until an ongoing pregnancy occurred by natural conception within a time horizon of 36 months. Direct medical costs included the surgical treatment of the initial tubal pregnancy, readmissions including reinterventions, treatment for persistent trophoblast and interventions for repeat ectopic pregnancy. The analysis was performed according to the intention-to-treat principle.MAIN RESULTS AND THE ROLE OF CHANCE: Mean direct medical costs per woman in the salpingotomy group and in the salpingectomy group were €3319 versus €2958, respectively, with a mean difference of €361 (95% confidence interval €217 to €515). Salpingotomy resulted in a marginally higher ongoing pregnancy rate by natural conception compared with salpingectomy leading to an incremental cost-effectiveness ratio €40 982 (95% confidence interval -€130 319 to €145 491) per ongoing pregnancy. Since salpingotomy resulted in more additional treatments for persistent trophoblast and interventions for repeat ectopic pregnancy, the incremental cost-effectiveness ratio was not informative.LIMITATIONS, REASONS FOR CAUTION: Costs of any subsequent IVF cycles were not included in this analysis. The analysis was limited to the perspective of the hospital.WIDER IMPLICATIONS OF THE FINDINGS: However, a small treatment benefit of salpingotomy might be enough to cover the costs of subsequent IVF. This uncertainty should be incorporated in shared decision-making. Whether salpingotomy should be offered depends on society's willingness to pay for an additional child.STUDY FUNDING/COMPETING INTERESTS: Netherlands Organisation for Health Research and Development, Region Västra Götaland Health & Medical Care Committee.TRIAL REGISTRATION NUMBER: ISRCTN37002267.
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- 2015
22. Hysteroscopy Before In-Vitro Fertilisation (inSIGHT): A Multicentre, Randomised Controlled Trial
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Smit, Janine G., primary, Kasius, Jenneke C., additional, Eijkemans, Marinus J. C., additional, Koks, Carolien A. M., additional, van Golde, Ronald, additional, Nap, Annemiek W., additional, Scheffer, Gabrielle J., additional, Manger, Petra A. P., additional, Hoek, Annemieke, additional, Schoot, Benedictus C., additional, van Heusden, Arne M., additional, Kuchenbecker, Walter K. H., additional, Perquin, Denise A. M., additional, Fleischer, Kathrin, additional, Kaaijk, Eugenie M., additional, Sluijmer, Alexander, additional, Friederich, Jaap, additional, Dykgraaf, Ramon H. M., additional, van Hooff, Marcel, additional, Louwe, Leonie A., additional, Kwee, Janet, additional, de Koning, Corry H., additional, Janssen, Ineke C. A. H., additional, Mol, Femke, additional, Mol, Ben W. J., additional, Broekmans, Frank J. M., additional, and Torrance, Helen L., additional
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- 2016
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23. Hysteroscopy before In-Vitro Fertilisation (inSIGHT) : A Multicentre, Randomised Controlled Trial
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Smit, Janine G., Kasius, Jenneke C., Eijkemans, Marinus J C, Koks, Carolien A M, Van Golde, Ronald, Nap, Annemiek W., Scheffer, Gabrielle J., Manger, Petra A P, Hoek, Annemieke, Schoot, Benedictus C., Van Heusden, Arne M., Kuchenbecker, Walter K H, Perquin, Denise A M, Fleischer, Kathrin, Kaaijk, Eugenie M., Sluijmer, Alexander, Friederich, Jaap, Dykgraaf, Ramon H M, Van Hooff, Marcel, Louwe, Leonie A., Kwee, Janet, De Koning, Corry H., Janssen, Ineke C A H, Mol, Femke, Mol, Ben W J, Broekmans, Frank J M, Torrance, Helen L., Smit, Janine G., Kasius, Jenneke C., Eijkemans, Marinus J C, Koks, Carolien A M, Van Golde, Ronald, Nap, Annemiek W., Scheffer, Gabrielle J., Manger, Petra A P, Hoek, Annemieke, Schoot, Benedictus C., Van Heusden, Arne M., Kuchenbecker, Walter K H, Perquin, Denise A M, Fleischer, Kathrin, Kaaijk, Eugenie M., Sluijmer, Alexander, Friederich, Jaap, Dykgraaf, Ramon H M, Van Hooff, Marcel, Louwe, Leonie A., Kwee, Janet, De Koning, Corry H., Janssen, Ineke C A H, Mol, Femke, Mol, Ben W J, Broekmans, Frank J M, and Torrance, Helen L.
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- 2016
24. Randomized trial of a lifestyle program in obese infertile women
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Mutsaerts, Meike A Q, Van Oers, Anne M., Groen, Henk, Burggraaff, Jan M., Kuchenbecker, Walter K H, Perquin, Denise A M, Koks, Carolien A M, Van Golde, Ron, Kaaijk, Eugenie M., Schierbeek, Jaap M., Oosterhuis, Gerrit J E, Broekmans, Frank J., Bemelmans, Wanda J E, Lambalk, Cornelis B., Verberg, Marieke F G, Van Der Veen, Fulco, Klijn, Nicole F., Mercelina, Patricia E A M, Van Kasteren, Yvonne M., Nap, Annemiek W., Brinkhuis, Egbert A., Vogel, Niels E A, Mulder, Robert J A B, Gondrie, Ed T C M, De Bruin, Jan P., Sikkema, J. Marko, De Greef, Mathieu H G, Ter Bogt, Nancy C W, Land, Jolande A., Mol, Ben W J, Hoek, Annemieke, Mutsaerts, Meike A Q, Van Oers, Anne M., Groen, Henk, Burggraaff, Jan M., Kuchenbecker, Walter K H, Perquin, Denise A M, Koks, Carolien A M, Van Golde, Ron, Kaaijk, Eugenie M., Schierbeek, Jaap M., Oosterhuis, Gerrit J E, Broekmans, Frank J., Bemelmans, Wanda J E, Lambalk, Cornelis B., Verberg, Marieke F G, Van Der Veen, Fulco, Klijn, Nicole F., Mercelina, Patricia E A M, Van Kasteren, Yvonne M., Nap, Annemiek W., Brinkhuis, Egbert A., Vogel, Niels E A, Mulder, Robert J A B, Gondrie, Ed T C M, De Bruin, Jan P., Sikkema, J. Marko, De Greef, Mathieu H G, Ter Bogt, Nancy C W, Land, Jolande A., Mol, Ben W J, and Hoek, Annemieke
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- 2016
25. Hysteroscopy before In-Vitro Fertilisation (inSIGHT): A Multicentre, Randomised Controlled Trial
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MS VPG/Gynaecologie, Arts-assistenten DV&B, Biostatistiek Onderzoek, Circulatory Health, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, Child Health, Fertiliteitartsen, Smit, Janine G., Kasius, Jenneke C., Eijkemans, Marinus J C, Koks, Carolien A M, Van Golde, Ronald, Nap, Annemiek W., Scheffer, Gabrielle J., Manger, Petra A P, Hoek, Annemieke, Schoot, Benedictus C., Van Heusden, Arne M., Kuchenbecker, Walter K H, Perquin, Denise A M, Fleischer, Kathrin, Kaaijk, Eugenie M., Sluijmer, Alexander, Friederich, Jaap, Dykgraaf, Ramon H M, Van Hooff, Marcel, Louwe, Leonie A., Kwee, Janet, De Koning, Corry H., Janssen, Ineke C A H, Mol, Femke, Mol, Ben W J, Broekmans, Frank J M, Torrance, Helen L., MS VPG/Gynaecologie, Arts-assistenten DV&B, Biostatistiek Onderzoek, Circulatory Health, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, Child Health, Fertiliteitartsen, Smit, Janine G., Kasius, Jenneke C., Eijkemans, Marinus J C, Koks, Carolien A M, Van Golde, Ronald, Nap, Annemiek W., Scheffer, Gabrielle J., Manger, Petra A P, Hoek, Annemieke, Schoot, Benedictus C., Van Heusden, Arne M., Kuchenbecker, Walter K H, Perquin, Denise A M, Fleischer, Kathrin, Kaaijk, Eugenie M., Sluijmer, Alexander, Friederich, Jaap, Dykgraaf, Ramon H M, Van Hooff, Marcel, Louwe, Leonie A., Kwee, Janet, De Koning, Corry H., Janssen, Ineke C A H, Mol, Femke, Mol, Ben W J, Broekmans, Frank J M, and Torrance, Helen L.
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- 2016
26. Randomized trial of a lifestyle program in obese infertile women
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MS VPG/Gynaecologie, Circulatory Health, Child Health, HAG Netwerken, Epidemiology & Health Economics, Mutsaerts, Meike A Q, Van Oers, Anne M., Groen, Henk, Burggraaff, Jan M., Kuchenbecker, Walter K H, Perquin, Denise A M, Koks, Carolien A M, Van Golde, Ron, Kaaijk, Eugenie M., Schierbeek, Jaap M., Oosterhuis, Gerrit J E, Broekmans, Frank J., Bemelmans, Wanda J E, Lambalk, Cornelis B., Verberg, Marieke F G, Van Der Veen, Fulco, Klijn, Nicole F., Mercelina, Patricia E A M, Van Kasteren, Yvonne M., Nap, Annemiek W., Brinkhuis, Egbert A., Vogel, Niels E A, Mulder, Robert J A B, Gondrie, Ed T C M, De Bruin, Jan P., Sikkema, J. Marko, De Greef, Mathieu H G, Ter Bogt, Nancy C W, Land, Jolande A., Mol, Ben W J, Hoek, Annemieke, MS VPG/Gynaecologie, Circulatory Health, Child Health, HAG Netwerken, Epidemiology & Health Economics, Mutsaerts, Meike A Q, Van Oers, Anne M., Groen, Henk, Burggraaff, Jan M., Kuchenbecker, Walter K H, Perquin, Denise A M, Koks, Carolien A M, Van Golde, Ron, Kaaijk, Eugenie M., Schierbeek, Jaap M., Oosterhuis, Gerrit J E, Broekmans, Frank J., Bemelmans, Wanda J E, Lambalk, Cornelis B., Verberg, Marieke F G, Van Der Veen, Fulco, Klijn, Nicole F., Mercelina, Patricia E A M, Van Kasteren, Yvonne M., Nap, Annemiek W., Brinkhuis, Egbert A., Vogel, Niels E A, Mulder, Robert J A B, Gondrie, Ed T C M, De Bruin, Jan P., Sikkema, J. Marko, De Greef, Mathieu H G, Ter Bogt, Nancy C W, Land, Jolande A., Mol, Ben W J, and Hoek, Annemieke
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- 2016
27. Randomized Trial of a Lifestyle Program in Obese Infertile Women
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Mutsaerts, Meike A. Q., primary, van Oers, Anne M., additional, Groen, Henk, additional, Burggraaff, Jan M., additional, Kuchenbecker, Walter K. H., additional, Perquin, Denise A. M., additional, Koks, Carolien A. M., additional, van Golde, Ron, additional, Kaaijk, Eugenie M., additional, Schierbeek, Jaap M., additional, Oosterhuis, Gerrit J. E., additional, Broekmans, Frank J., additional, Bemelmans, Wanda J. E., additional, Lambalk, Cornelis B., additional, Verberg, Marieke F. G., additional, van der Veen, Fulco, additional, Klijn, Nicole F., additional, Mercelina, Patricia E. A. M., additional, van Kasteren, Yvonne M., additional, Nap, Annemiek W., additional, Brinkhuis, Egbert A., additional, Vogel, Niels E. A., additional, Mulder, Robert J. A. B., additional, Gondrie, Ed T. C. M., additional, de Bruin, Jan P., additional, Sikkema, J. Marko, additional, de Greef, Mathieu H. G., additional, ter Bogt, Nancy C. W., additional, Land, Jolande A., additional, Mol, Ben W. J., additional, and Hoek, Annemieke, additional
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- 2016
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28. A Randomized Trial of Progesterone in Women with Recurrent Miscarriages
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Coomarasamy, Arri, Williams, Helen, Truchanowicz, Ewa, Seed, Paul T, Small, Rachel, Quenby, Siobhan, Gupta, Pratima, Dawood, Feroza, Koot, Yvonne E M, Bender Atik, Ruth, Bloemenkamp, Kitty W M, Brady, Rebecca, Briley, Annette L, Cavallaro, Rebecca, Cheong, Ying C, Chu, Justin J, Eapen, Abey, Ewies, Ayman, Hoek, Annemieke, Kaaijk, Eugenie M, Koks, Carolien A M, Li, Tin-Chiu, MacLean, Marjory, Mol, Ben W, Moore, Judith, Ross, Jackie A, Sharpe, Lisa, Stewart, Jane, Vaithilingam, Nirmala, Farquharson, Roy G, Kilby, Mark D, Khalaf, Yacoub, Goddijn, Mariette, Regan, Lesley, Rai, Rajendra, Coomarasamy, Arri, Williams, Helen, Truchanowicz, Ewa, Seed, Paul T, Small, Rachel, Quenby, Siobhan, Gupta, Pratima, Dawood, Feroza, Koot, Yvonne E M, Bender Atik, Ruth, Bloemenkamp, Kitty W M, Brady, Rebecca, Briley, Annette L, Cavallaro, Rebecca, Cheong, Ying C, Chu, Justin J, Eapen, Abey, Ewies, Ayman, Hoek, Annemieke, Kaaijk, Eugenie M, Koks, Carolien A M, Li, Tin-Chiu, MacLean, Marjory, Mol, Ben W, Moore, Judith, Ross, Jackie A, Sharpe, Lisa, Stewart, Jane, Vaithilingam, Nirmala, Farquharson, Roy G, Kilby, Mark D, Khalaf, Yacoub, Goddijn, Mariette, Regan, Lesley, and Rai, Rajendra
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- 2015
29. ALIFE2 study : Low-molecular-weight heparin for women with recurrent miscarriage and inherited thrombophilia - study protocol for a randomized controlled trial
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de Jong, Paulien G., Quenby, Siobhan, Bloemenkamp, Kitty W M, Braams-Lisman, Babette A M, de Bruin, Peter J., Coomarasamy, Arri, David, Michele, DeSancho, Maria T., van der Heijden, Olivier W H, Hoek, Annemieke, Hutten, Barbara A., Jochmans, Kristin, Koks, Carolien A M, Kuchenbecker, Walter K H, Mol, Willem B., Torrance, Helen L., Scheepers, Hubertina C J, Stephenson, Mary D., Verhoeve, Harold R., Visser, Jantien, de Vries, Johanna I P, Goddijn, Mariëtte, Middeldorp, Saskia, de Jong, Paulien G., Quenby, Siobhan, Bloemenkamp, Kitty W M, Braams-Lisman, Babette A M, de Bruin, Peter J., Coomarasamy, Arri, David, Michele, DeSancho, Maria T., van der Heijden, Olivier W H, Hoek, Annemieke, Hutten, Barbara A., Jochmans, Kristin, Koks, Carolien A M, Kuchenbecker, Walter K H, Mol, Willem B., Torrance, Helen L., Scheepers, Hubertina C J, Stephenson, Mary D., Verhoeve, Harold R., Visser, Jantien, de Vries, Johanna I P, Goddijn, Mariëtte, and Middeldorp, Saskia
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- 2015
30. A Randomized Trial of Progesterone in Women with Recurrent Miscarriages
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Arts-assistenten DV&B, Geboortecentrum voorzitterschap, Coomarasamy, Arri, Williams, Helen, Truchanowicz, Ewa, Seed, Paul T, Small, Rachel, Quenby, Siobhan, Gupta, Pratima, Dawood, Feroza, Koot, Yvonne E M, Bender Atik, Ruth, Bloemenkamp, Kitty W M, Brady, Rebecca, Briley, Annette L, Cavallaro, Rebecca, Cheong, Ying C, Chu, Justin J, Eapen, Abey, Ewies, Ayman, Hoek, Annemieke, Kaaijk, Eugenie M, Koks, Carolien A M, Li, Tin-Chiu, MacLean, Marjory, Mol, Ben W, Moore, Judith, Ross, Jackie A, Sharpe, Lisa, Stewart, Jane, Vaithilingam, Nirmala, Farquharson, Roy G, Kilby, Mark D, Khalaf, Yacoub, Goddijn, Mariette, Regan, Lesley, Rai, Rajendra, Arts-assistenten DV&B, Geboortecentrum voorzitterschap, Coomarasamy, Arri, Williams, Helen, Truchanowicz, Ewa, Seed, Paul T, Small, Rachel, Quenby, Siobhan, Gupta, Pratima, Dawood, Feroza, Koot, Yvonne E M, Bender Atik, Ruth, Bloemenkamp, Kitty W M, Brady, Rebecca, Briley, Annette L, Cavallaro, Rebecca, Cheong, Ying C, Chu, Justin J, Eapen, Abey, Ewies, Ayman, Hoek, Annemieke, Kaaijk, Eugenie M, Koks, Carolien A M, Li, Tin-Chiu, MacLean, Marjory, Mol, Ben W, Moore, Judith, Ross, Jackie A, Sharpe, Lisa, Stewart, Jane, Vaithilingam, Nirmala, Farquharson, Roy G, Kilby, Mark D, Khalaf, Yacoub, Goddijn, Mariette, Regan, Lesley, and Rai, Rajendra
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- 2015
31. Cost-effectiveness of salpingotomy and salpingectomy in women with tubal pregnancy (a randomized controlled trial)
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MS VPG/Gynaecologie, Child Health, Broekmans, FJM, Mol, F., Mello, N.M., Strandell, Annika, Strandell, Karin, Jurkovic, Davor, Ross, Jackie, Barnhart, K., Yalcinkaya, Tamer, Verhoeve, H.R., Graziosi, G.C.M., Koks, Carolien A M, Klinte, Ingmar, Hogstrom, Lars, Janssen, Ineke, Kragt, Harry, Hoek, Annemieke, Trimbos-Kemper, Trudy, Willemsen, Wim, Ankum, W.M., Mol, Benwillem, Wely, M., van der Veen, Fulco, Hajenius, Petra J, MS VPG/Gynaecologie, Child Health, Broekmans, FJM, Mol, F., Mello, N.M., Strandell, Annika, Strandell, Karin, Jurkovic, Davor, Ross, Jackie, Barnhart, K., Yalcinkaya, Tamer, Verhoeve, H.R., Graziosi, G.C.M., Koks, Carolien A M, Klinte, Ingmar, Hogstrom, Lars, Janssen, Ineke, Kragt, Harry, Hoek, Annemieke, Trimbos-Kemper, Trudy, Willemsen, Wim, Ankum, W.M., Mol, Benwillem, Wely, M., van der Veen, Fulco, and Hajenius, Petra J
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- 2015
32. ALIFE2 study: Low-molecular-weight heparin for women with recurrent miscarriage and inherited thrombophilia - study protocol for a randomized controlled trial
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Fertiliteitartsen, Child Health, de Jong, Paulien G., Quenby, Siobhan, Bloemenkamp, Kitty W M, Braams-Lisman, Babette A M, de Bruin, Peter J., Coomarasamy, Arri, David, Michele, DeSancho, Maria T., van der Heijden, Olivier W H, Hoek, Annemieke, Hutten, Barbara A., Jochmans, Kristin, Koks, Carolien A M, Kuchenbecker, Walter K H, Mol, Willem B., Torrance, Helen L., Scheepers, Hubertina C J, Stephenson, Mary D., Verhoeve, Harold R., Visser, Jantien, de Vries, Johanna I P, Goddijn, Mariëtte, Middeldorp, Saskia, Fertiliteitartsen, Child Health, de Jong, Paulien G., Quenby, Siobhan, Bloemenkamp, Kitty W M, Braams-Lisman, Babette A M, de Bruin, Peter J., Coomarasamy, Arri, David, Michele, DeSancho, Maria T., van der Heijden, Olivier W H, Hoek, Annemieke, Hutten, Barbara A., Jochmans, Kristin, Koks, Carolien A M, Kuchenbecker, Walter K H, Mol, Willem B., Torrance, Helen L., Scheepers, Hubertina C J, Stephenson, Mary D., Verhoeve, Harold R., Visser, Jantien, de Vries, Johanna I P, Goddijn, Mariëtte, and Middeldorp, Saskia
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- 2015
33. Association between periconceptional weight loss and maternal and neonatal outcomes in obese infertile women.
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van Oers, Anne M., Mutsaerts, Meike A. Q., Burggraaff, Jan M., Kuchenbecker, Walter K. H., Perquin, Denise A. M., Koks, Carolien A. M., van Golde, Ron, Kaaijk, Eugenie M., Broekmans, Frank J., de Bruin, Jan Peter, van der Veen, Fulco, Nap, Annemiek W., Gondrie, Ed T. C. M., Mol, Ben W. J., Groen, Henk, Hoek, Annemieke, and null, null
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OBESITY in women ,WEIGHT loss ,FEMALE infertility ,BODY mass index ,PREGNANCY - Abstract
Background: Obesity in women of reproductive age has deleterious effects on reproductive and offspring health. In this study, we aimed to evaluate the association between the magnitude of periconceptional body-mass index (BMI) change and maternal and neonatal outcomes in obese infertile women who participated in the LIFEstyle study. The LIFEstyle study was a randomized controlled trial, evaluating if a six-month lifestyle intervention program prior to infertility treatment in obese infertile women improved birth rates, compared to prompt infertility treatment. Methods and findings: This is an exploratory post hoc analysis of the LIFEstyle study. We recorded periconceptional BMI change in women with an ongoing pregnancy, pooling data of all women, regardless of randomization arm. Periconceptional BMI change was calculated using weight at randomization and the periconceptional weight (measured in kilograms 12 weeks before or after conception and expressed as BMI change in units BMI (kg/m
2 )). Subsequently, women were categorized into quartiles according to the magnitude of their periconceptional change in BMI. The odds of maternal and neonatal outcomes were calculated using logistic regression analysis, comparing women in each of the first three weight change quartiles separately, and combined, to women in the fourth quartile. The fourth quartile was chosen as reference group, since these women had the least weight loss. We adjusted for periconceptional BMI, nulliparity and smoking status. In addition, we performed a subgroup analysis for singleton pregnancies. In the LIFEstyle study, 321 obese infertile women achieved an ongoing pregnancy which was conceived within 24 months after randomization. Periconceptional BMI change was available in 244 of these women (76%). Median BMI at randomization was 35.9 kg/m2 . Women in the first quartile (Q1) had a periconceptional BMI change of <-2.1 kg/m2 , women in the second quartile (Q2) -2.1 to -0.9 kg/m2 , women in the third quartile (Q3) -0.9 to 0.1 kg/m2 and women in the fourth quartile (Q4) gained ≥0.1 kg/m2 . There were no significant differences between women in the quartiles regarding rates of excessive gestational weight gain (in term pregnancies), gestational diabetes, preterm birth, induction of labor, spontaneous vaginal birth and Caesarean section. Compared to women in Q4, the adjusted odds ratios, aOR, and 95% confidence interval for a hypertensive complication were; 0.55 (0.22–1.42) for women in Q1, 0.30 (0.12–0.78) for women in Q2, 0.39 (0.16–0.96) for women in Q3 and 0.39 (0.19–0.82) for women in Q1 to Q3 combined. In the subgroup analysis, investigating singleton pregnancies only, the statistically significant decreased rate of a hypertensive complication remained in women in Q2 (aOR 0.27, 95% CI 0.10–0.72) and Q3 (aOR 0.39, 95%CI 0.16–0.98) and when comparing women in Q1 to Q3 together to women in Q4 (aOR 0.38, 95%CI 0.18–0.80). Furthermore, there was a significantly decreased aOR (95%CI) of preterm birth in women in Q2 (0.24, 0.06–0.98) and when combining women in Q1 to Q3 (0.37, 0.14–0.97) compared to women in Q4. Conclusions: These results suggest that a periconceptional decrease in BMI in obese infertile women could lead to a decrease of the rates of hypertensive pregnancy complications and preterm birth. The results are limited by the exploratory nature of the analyses and further evidence is necessary to provide more definitive conclusions. [ABSTRACT FROM AUTHOR]- Published
- 2018
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34. Tubal anastomosis after previous sterilization: a systematic review.
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van Seeters, Jacoba A. H., Su Jen Chua, Mol, Ben W. J., Koks, Carolien A. M., and Chua, Su Jen
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STERILIZATION of women ,LAPAROSCOPY ,OPERATIVE surgery ,ECTOPIC pregnancy ,META-analysis ,ABDOMINAL surgery ,FALLOPIAN tube surgery ,TUBAL sterilization ,AGE distribution ,BIRTH rate ,LONGITUDINAL method ,STERILIZATION reversal ,SYSTEMATIC reviews ,TREATMENT effectiveness ,RETROSPECTIVE studies ,PSYCHOLOGY - Abstract
Background: Female sterilization is one of the most common contraceptive methods. A small number of women, however, opt for reversal of sterilization procedures after they experience regret. Procedures can be performed by laparotomy or laparoscopy, with or without robotic assistance. Another commonly utilized alternative is IVF. The choice between surgery and IVF is often influenced by reimbursement politics for that particular geographic location.Objective and Rationale: We evaluated the fertility outcomes of different surgical methods available for the reversal of female sterilization, compared these to IVF and assessed the prognostic factors for success.Search Methods: Two search strategies were employed. Firstly, we searched for randomized and non-randomized clinical studies presenting fertility outcomes of sterilization reversal up to July 2016. Data on the following outcomes were collected: pregnancy rate, ectopic pregnancy rate, cost of the procedure and operative time. Eligible study designs included prospective or retrospective studies, randomized controlled trials, cohort studies, case-control studies and case series. No age restriction was applied. Exclusion criteria were patients suffering from tubal infertility from any other reason (e.g. infection, endometriosis and adhesions from previous surgery) and studies including <10 participants. The following factors likely to influence the success of sterilization reversal procedures were then evaluated: female age, BMI and duration and method of sterilization. Secondly, we searched for randomized and non-randomized clinical studies that compared reversal of sterilization to IVF and evaluated them for pregnancy outcomes and cost effectiveness.Outcomes: We included 37 studies that investigated a total of 10 689 women. No randomized controlled trials were found. Most studies were retrospective cohort studies of a moderate quality. The pooled pregnancy rate after sterilization reversal was 42-69%, with heterogeneity seen from the different methods utilized. The reported ectopic pregnancy rate was 4-8%. The only prognostic factor affecting the chance of conception was female age. The surgical approach (i.e. laparotomy [microscopic], laparoscopy or robotic) had no impact on the outcome, with the exception of the macroscopic laparotomic technique, which had inferior results and is not currently utilized. For older women, IVF could be a more cost-effective alternative for the reversal of sterilization. However, direct comparative data are lacking and a cut-off age cannot be stated.Wider Implications: In sterilized women who suffer regret, surgical tubal re-anastomosis is an effective treatment, especially in younger women. However, there is a need for randomized controlled trials comparing the success rates and costs of surgical reversal with IVF. [ABSTRACT FROM AUTHOR]- Published
- 2017
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35. The ESEP study : salpingostomy versus salpingectomy for tubal ectopic pregnancy; the impact on future fertility : a randomised controlled trial
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Mol, Femke, Strandell, Annika, Jurkovic, Davor, Yalcinkaya, Tamer, Verhoeve, Harold R., Koks, Carolien A. M., van der Linden, Paul J. Q., Graziosi, Giuseppe C. M., Thurkow, Andreas L., Hoek, Annemieke, Hogström, Lars, Klinte, Ingemar, Nilsson, Kerstin, van Mello, Norah M., Ankum, Willem M., van der Veen, Fulco, Mol, Ben W. M., Hajenius, Petra J., Mol, Femke, Strandell, Annika, Jurkovic, Davor, Yalcinkaya, Tamer, Verhoeve, Harold R., Koks, Carolien A. M., van der Linden, Paul J. Q., Graziosi, Giuseppe C. M., Thurkow, Andreas L., Hoek, Annemieke, Hogström, Lars, Klinte, Ingemar, Nilsson, Kerstin, van Mello, Norah M., Ankum, Willem M., van der Veen, Fulco, Mol, Ben W. M., and Hajenius, Petra J.
- Abstract
BACKGROUND: For most tubal ectopic pregnancies (EP) surgery is the treatment of first choice. Whether surgical treatment should be performed conservatively (salpingostomy) or radically (salpingectomy) in women wishing to preserve their reproductive capacity, is subject to debate. Salpingostomy preserves the tube, but bears the risks of both persistent trophoblast and repeat ipsilateral tubal EP. Salpingectomy, avoids these risks, but leaves only one tube for reproductive capacity. This study aims to reveal the trade-off between both surgical options: whether the potential advantage of salpingostomy, i.e. a better fertility prognosis as compared to salpingectomy, outweighs the potential disadvantages, i.e. persistent trophoblast and an increased risk for a repeat EP. METHODS/DESIGN: International multi centre randomised controlled trial comparing salpingostomy versus salpingectomy in women with a tubal EP without contra lateral tubal pathology. Hemodynamically stable women with a presumptive diagnosis of tubal EP, scheduled for surgery, are eligible for inclusion. Patients pregnant after in vitro fertilisation (IVF) and/or known documented tubal pathology are excluded. At surgery, a tubal EP must be confirmed. Only women with a tubal EP amenable to both interventions and a healthy contra lateral tube are included. Salpingostomy and salpingectomy are performed according to standard procedures of participating hospitals. Up to 36 months after surgery, women will be contacted to assess their fertility status at six months intervals starting form the day of the operation.The primary outcome measure is the occurrence of spontaneous viable intra uterine pregnancy. Secondary outcome measures are persistent trophoblast, repeat EP, all pregnancies including those resulting from IVF and financial costs. The analysis will be performed according to the intention to treat principle. A cost-effectiveness analysis will be performed within a decision analysis framework, based on cos
- Published
- 2008
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36. ALIFE2 study: low-molecular-weight heparin for women with recurrent miscarriage and inherited thrombophilia - study protocol for a randomized controlled trial
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de Jong, Paulien G, Quenby, Siobhan, Bloemenkamp, Kitty W. M., Braams-Lisman, Babette A. M., de Bruin, Jan Peter, Coomarasamy, Arri, David, Michele, DeSancho, Maria T, van der Heijden, Olivier W. H., Hoek, Annemieke, Hutten, Barbara A, Jochmans, Kristin, Koks, Carolien A. M., Kuchenbecker, Walter K. H., Mol, Ben Willem J, Torrance, Helen L, Scheepers, Hubertina C. J., Stephenson, Mary D, Verhoeve, Harold R, and Visser, Jantien
- Abstract
Background: A large number of studies have shown an association between inherited thrombophilia and recurrent miscarriage. It has been hypothesized that anticoagulant therapy might reduce the number of miscarriages and stillbirth in these women. In the absence of randomized controlled trials evaluating the efficacy of anticoagulant therapy in women with inherited thrombophilia and recurrent miscarriage, a randomized trial with adequate power that addresses this question is needed. The objective of the ALIFE2 study is therefore to evaluate the efficacy of low-molecular-weight heparin (LMWH) in women with inherited thrombophilia and recurrent miscarriage, with live birth as the primary outcome. Methods/Design: Randomized study of LMWH plus standard pregnancy surveillance versus standard pregnancy surveillance alone. Study population: pregnant women of less than 7 weeks’ gestation, and confirmed inherited thrombophilia with a history of 2 or more miscarriages or intra-uterine fetal deaths, or both. Setting: multi-center study in centers from the Dutch Consortium of Fertility studies; centers outside the Netherlands are currently preparing to participate. Intervention: LMWH enoxaparin 40 mg subcutaneously once daily started prior to 7 weeks gestational age plus standard pregnancy surveillance or standard pregnancy surveillance alone. Main study parameters/endpoints: the primary efficacy outcome is live birth. Secondary efficacy outcomes include adverse pregnancy outcomes, such as miscarriage, pre-eclampsia, syndrome of hemolysis, elevated liver enzymes and low platelets (HELLP syndrome), fetal growth restriction, placental abruption, premature delivery and congenital malformations. Safety outcomes include bleeding episodes, thrombocytopenia and skin reactions. Discussion: After an initial period of slow recruitment, the recruitment rate for the study has increased. Improved awareness of the study and acknowledgement of the need for evidence are thought to be contributing to the improved recruitment rates. We aim to increase the number of recruiting centers in order to increase enrollment into the ALIFE2 study. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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37. The inSIGHT study: costs and effects of routine hysteroscopy prior to a first IVF treatment cycle. A randomised controlled trial.
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Smit, Janine G., Kasius, Jenneke C., Eijkemans, Marinus J. C., Koks, Carolien A. M., Van Golde, Ron, Oosterhuis, Jurjen G. E., Nap, Annemiek W., Scheffer, Gabrielle J., Manger, Petra A. P., Hoek, Annemiek, Kaplan, Mesrure, Schoot, Dick B. C., van Heusden, Arne M., Kuchenbecker, Walter K. H., Perquin, Denise A. M., Fleischer, Kathrin, Kaaijk, Eugenie M., Sluijmer, Alexander, Friederich, Jaap, and Laven, Joop S. E.
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FERTILIZATION in vitro ,PREGNANCY ,HYSTEROSALPINGOGRAPHY ,HYSTEROSCOPY ,ULTRASONIC imaging ,LOGISTIC regression analysis - Abstract
Background: In in vitro fertilization (IVF) and intracytoplasmatic sperm injection (ICSI) treatment a large drop is present between embryo transfer and occurrence of pregnancy. The implantation rate per embryo transferred is only 30%. Studies have shown that minor intrauterine abnormalities can be found in 11-45% of infertile women with a normal transvaginal sonography or hysterosalpingography. Two randomised controlled trials have indicated that detection and treatment of these abnormalities by office hysteroscopy after two failed IVF cycles leads to a 9-13% increase in pregnancy rate. Therefore, screening of all infertile women for intracavitary pathology prior to the start of IVF/ICSI is increasingly advocated. In absence of a scientific basis for such a policy, this study will assess the effects and costs of screening for and treatment of unsuspected intrauterine abnormalities by routine office hysteroscopy, with or without saline infusion sonography (SIS), prior to a first IVF/ICSI cycle. Methods/design: Multicenter randomised controlled trial in asymptomatic subfertile women, indicated for a first IVF/ICSI treatment cycle, with normal findings at transvaginal sonography. Women with recurrent miscarriages, prior hysteroscopy treatment and intermenstrual blood loss will not be included. Participants will be randomised for a routine fertility work-up with additional (SIS and) hysteroscopy with on-the-spot-treatment of predefined intrauterine abnormalities versus the regular fertility work-up without additional diagnostic tests. The primary study outcome is the cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomisation. Secondary study outcome parameters are the cumulative implantation rate; cumulative miscarriage rate; patient preference and patient tolerance of a SIS and hysteroscopy procedure. All data will be analysed according to the intention-to-treat principle, using univariate and multivariate logistic regression and cox regression. Cost-effectiveness analysis will be performed to evaluate the costs of the additional tests as routine procedure. In total 700 patients will be included in this study. Discussion: The results of this study will help to clarify the significance of hysteroscopy prior to IVF treatment [ABSTRACT FROM AUTHOR]
- Published
- 2012
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38. The OPTIMIST study: optimisation of cost effectiveness through individualised FSH stimulation dosages for IVF treatment. A randomised controlled trial.
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van Tilborg, Theodora C., Eijkemans, Marinus J. C., Laven, Joop S. E., Koks, Carolien A. M., de Bruin, Jan Peter, Scheffer, Gabrielle J., van Golde, Ron J. T., Fleischer, Kathrin, Hoek, Annemieke, Nap, Annemiek W., Kuchenbecker, Walter K. H., Manger, Petra A., Brinkhuis, Egbert A., van Heusden, Arne M., Sluijmer, Alexander V., Verhoeff, Arie, van Hooff, Marcel H. A., Friederich, Jaap, Smeenk, Jesper M. J., and Kwee, Janet
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OBSTETRICS ,CHILDBIRTH ,WOMEN'S health ,ULTRASONIC imaging ,MENSTRUAL cycle - Abstract
Background: Costs of in vitro fertilisation (IVF) are high, which is partly due to the use of follicle stimulating hormone (FSH). FSH is usually administered in a standard dose. However, due to differences in ovarian reserve between women, ovarian response also differs with potential negative consequences on pregnancy rates. A Markov decision-analytic model showed that FSH dose individualisation according to ovarian reserve is likely to be cost-effective in women who are eligible for IVF. However, this has never been confirmed in a large randomised controlled trial (RCT). The aim of the present study is to assess whether an individualised FSH dose regime based on an ovarian reserve test (ORT) is more cost-effective than a standard dose regime. Methods/Design: Multicentre RCT in subfertile women indicated for a first IVF or intracytoplasmic sperm injection cycle, who are aged < 44 years, have a regular menstrual cycle and no major abnormalities at transvaginal sonography. Women with polycystic ovary syndrome, endocrine or metabolic abnormalities and women undergoing IVF with oocyte donation, will not be included. Ovarian reserve will be assessed by measuring the antral follicle count. Women with a predicted poor response or hyperresponse will be randomised for a standard versus an individualised FSH regime (150 IU/day, 225-450 IU/day and 100 IU/day, respectively). Participants will undergo a maximum of three stimulation cycles during maximally 18 months. The primary study outcome is the cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months after randomisation. Secondary outcomes are parameters for ovarian response, multiple pregnancies, number of cycles needed per live birth, total IU of FSH per stimulation cycle, and costs. All data will be analysed according to the intention-to-treat principle. Cost-effectiveness analysis will be performed to assess whether the health and associated economic benefits of individualised treatment of subfertile women outweigh the additional costs of an ORT. Discussion: The results of this study will be integrated into a decision model that compares cost-effectiveness of the three dose-adjustment strategies to a standard dose strategy. The study outcomes will provide scientific foundation for national and international guidelines. Trial registration: NTR2657 [ABSTRACT FROM AUTHOR]
- Published
- 2012
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39. Bipolar radiofrequency endometrial ablation compared with hydrothermablation for dysfunctional uterine bleeding: a randomized controlled trial.
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Penninx JP, Willem Mol B, Engels R, van Rumste MM, Kleijn C, Koks CA, Kruitwagen RF, Bongers MY, Penninx, Josien P M, Mol, Ben Willem, Engels, Ruben, van Rumste, Minouche M E, Kleijn, Channa, Koks, Carolien A M, Kruitwagen, Roy F P M, Bongers, Marlies Y, and Willem Mol, Ben
- Published
- 2010
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40. Essure removal surgery: Are preoperative transvaginal ultrasound and pelvic X-ray necessary?
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van Erp MAJM, Maassen LW, van Gastel DM, Koks CAM, Bongers MY, and Veersema S
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- Pregnancy, Female, Humans, Retrospective Studies, X-Rays, Hysteroscopy methods, Radiography, Ultrasonography, Sterilization, Tubal
- Abstract
Objective: The objective of this study was twofold. (1) To investigate the predictive characteristics of transvaginal ultrasonography for hysteroscopy necessity in Essure removal surgery. (2) To investigate the additional predictive value of a preoperative pelvic radiograph to transvaginal ultrasonography for hysteroscopy necessity., Study Design: Retrospective cohort study, performed in an academic and a non-academic teaching hospital in the Netherlands. 71 women who underwent Essure removal surgery with a perioperative hysteroscopy and who had a preoperative pelvic X-ray and transvaginal ultrasound were included. Four experts first predicted hysteroscopy necessity based on transvaginal ultrasound description and secondly based on transvaginal ultrasound combined with the preoperative pelvic radiograph. Sensitivity, specificity, positive predictive value and negative predictive value of the predictive tests were calculated., Results: Based on transvaginal ultrasound, the mean predictive characteristics for experts were: sensitivity 89.7% (range 66.7%-100%), specificity 37.4% (range 17.6%-67.7%), positive predictive value 18.8% (range 13.2%-29.5%) and negative predictive value 95.1% (range 86.1%-100%). After adding the pelvic radiograph to the transvaginal ultrasound descriptions, the results were: sensitivity 66.7% (range 53.3%-80%), specificity 72.6% (range 56%-97.3%), positive predictive value 23% (range 14.3%-26.9%) and negative predictive value 94.1 % (range 90.3%-98.4%). For three experts sensitivity decreased after adding the pelvic radiograph. For all experts specificity increased., Conclusion: It is difficult to preoperatively decide if the fourth marker of the Essure outer coil can be excised during hysteroscopy. The addition of pelvic radiography to transvaginal ultrasound is not beneficial. It is recommended to perform a hysteroscopy during Essure removal surgery., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)
- Published
- 2023
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41. Pain scores during oocyte retrieval for IVF/ICSI: A retrospective cohort study comparing three different analgesia protocols.
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Buisman ETIA, Roest I, van der Steeg JW, Smeenk JMJ, and Koks CAM
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- Aged, Alfentanil, Analgesics, Opioid, Female, Fertilization in Vitro methods, Humans, Pain, Retrospective Studies, Sperm Injections, Intracytoplasmic methods, Analgesia methods, Oocyte Retrieval methods
- Abstract
Objective: Oocyte retrieval is a painful, but essential element of IVF/ICSI. Evidence for the best method of analgesia is lacking. In the Netherlands, the three most common analgesia protocols entail administration of oral analgesics, intravenous opioids, and intramuscular opioids. The aim of this study was to compare these methods., Methods: A retrospective cohort study was conducted at three clinics. Clinic one provided oral analgesics (1000 mg paracetamol and 500 mg naproxen). The main component of analgesia at clinic two was opioids intravenously (50-100 µg fentanyl), and at clinic three, this was opioids intramuscularly (0.01 mg/kg alfentanil). Intraprocedural pain was registered on an 11-point scale. Univariate analyses were performed to identify factors significantly associated with pain scores. A mixed linear model was used to uncover mean pain scores per clinic., Results: In total, 2,127 oocyte retrievals were included. Pain scores were lower in older women; scores decreased 0.06 points per year (95%-confidence interval (CI): 0.04-0.08). Per extra follicle, scores were 0.05 points higher (95%-CI: 0.03-0.06). Endometriosis resulted in 0.45-point higher scores (95%-CI: 0.01-0.88). Primary subfertility resulted in a 0.36-point increase in scores (95%-CI: 0.15-0.56). Nulliparous women had a 0.41-point higher score than multiparous women (95%-CI: 0.19-0.63). These effects were mostly similar in all clinics. Mean pain scores were 5.6 at clinic number 1 (95%-CI: 5.3-5.8), 5.1 at clinic number 2 (95%-CI: 4.9-5.3), and 3.9 at clinic number 3 (95%-CI: 3.8-4.1)., Conclusion: The lowest pain scores were achieved in the clinic that used intramuscular administration of alfentanil, followed by intravenous fentanyl and, finally, non-sedative oral analgesics. Significant correlations between patient characteristics and pain scores were identified., Competing Interests: Conflict of Interest Declarations of interest: none., (Copyright © 2022. Published by Elsevier Masson SAS.)
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- 2022
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42. Perioperative findings and complications in Essure® removal surgery.
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Horsten DL, van Gastel DM, Maassen LW, Koks CAM, Veersema S, and Bongers MY
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- Fallopian Tubes surgery, Female, Humans, Hysteroscopy, Pregnancy, Prospective Studies, Salpingectomy adverse effects, Sterilization, Tubal adverse effects
- Abstract
Objective: To analyze perioperative findings and complications in surgical removal of Essure® microinserts., Study Design: A prospective cohort study of 274 patients who underwent surgical removal of Essure® microinserts. Outcomes of the surgical procedures and complications were entered into a digital case report form (CRF) by the surgeon and registered in an online database. Results were analyzed through IBM SPSS Statistics using descriptive statistical methods., Results: During laparoscopic inspection in 15.4 % of fallopian tubes (n = 80) a chicken wing sign (the fallopian tube folding over the most distal part of the microinsert) was seen. Partial tubal perforation and total tubal perforation with migration of the microinsert out of the fallopian tube were seen in respectively 1.9 % (n = 10) and 0.2 % (n = 1) of cases. The microinserts were removed by laparoscopic tubotomy and extraction, followed by bilateral salpingectomy in 91.2 % of cases. In 7.3 % of cases (n = 20) a hysterectomy and bilateral salpingectomy was performed for additional indications than solely Essure® removal. Four microinserts were taken out entirely by means of hysteroscopy (1.5 %). We did not see major surgery related complications, however we found a risk of minor complications during or after surgery of respectively 1.6 % (n = 4) and 3.9 % (n = 10)., Conclusions: During laparoscopic inspection, abnormalities were seen in 22.8 % (n = 119) of fallopian tubes, of which the chicken wing sign was the most common. Partial and total tubal perforation with migration of the microinsert were rare. The complication rate of Essure® removal surgery in our prospective study is low and complications are minor, without any major complication. However, while counseling patients with a request for surgical removal of Essure® microinserts, these results should be mentioned., Competing Interests: Declaration of Competing Interest None., (Copyright © 2021. Published by Elsevier B.V.)
- Published
- 2021
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43. Different methods of pain relief for IVF and ICSI oocyte retrieval - A Dutch survey.
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Roest I, Buisman ETIA, van der Steeg JW, and Koks CAM
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Objective: Which analgesia methods are used during oocyte retrieval in the Netherlands?, Studydesign: In April 2017, an online survey containing questions on the analgesia protocol used for IVF/ICSI oocyte retrieval was sent to all clinics in the Netherlands that perform oocyte retrievals., Results: The response rate was 97%. We uncovered the large variety of medication protocols used for pain relief during oocyte retrieval in the Netherlands. Based on the main component of the given analgesia, we distinguished the three most frequently used analgesia protocols: intravenously (i.v.) administered opioids, intramuscularly (i.m) administered opioids, and non-sedative oral analgesics. Aside from analgesia, 61% provided anxiolysis with a benzodiazepine. Nearly half of the clinics registered pain scores. The vital functions were monitored at all clinics administering opioids i.v., but at none of the clinics administering opioids i.m., Conclusions: A wide variety of analgesia protocols are used. The three most frequently used are i.v. administered opioids, i.m. administered opioids, and non-sedative oral analgesics. The variety of analgesia protocols is not desirable in the context of good clinical practice, and considering the risks of combining opioids and benzodiazepines. Monitoring of vital functions was only performed after administration of i.v. medication. A comparison of the pain scores could be a first step in finding the optimal method of analgesia, thereby forming the basis of guidelines for analgesia during oocyte retrieval.
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- 2019
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44. Randomized Trial of a Lifestyle Program in Obese Infertile Women.
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Mutsaerts MA, van Oers AM, Groen H, Burggraaff JM, Kuchenbecker WK, Perquin DA, Koks CA, van Golde R, Kaaijk EM, Schierbeek JM, Oosterhuis GJ, Broekmans FJ, Bemelmans WJ, Lambalk CB, Verberg MF, van der Veen F, Klijn NF, Mercelina PE, van Kasteren YM, Nap AW, Brinkhuis EA, Vogel NE, Mulder RJ, Gondrie ET, de Bruin JP, Sikkema JM, de Greef MH, ter Bogt NC, Land JA, Mol BW, and Hoek A
- Subjects
- Adult, Birth Rate, Body Mass Index, Female, Humans, Infertility, Female etiology, Intention to Treat Analysis, Obesity complications, Pregnancy, Reproductive Techniques, Assisted, Weight Loss, Young Adult, Diet, Reducing, Exercise, Infertility, Female therapy, Life Style, Obesity therapy
- Abstract
Background: Small lifestyle-intervention studies suggest that modest weight loss increases the chance of conception and may improve perinatal outcomes, but large randomized, controlled trials are lacking., Methods: We randomly assigned infertile women with a body-mass index (the weight in kilograms divided by the square of the height in meters) of 29 or higher to a 6-month lifestyle intervention preceding treatment for infertility or to prompt treatment for infertility. The primary outcome was the vaginal birth of a healthy singleton at term within 24 months after randomization., Results: We assigned women who did not conceive naturally to one of two treatment strategies: 290 women were assigned to a 6-month lifestyle-intervention program preceding 18 months of infertility treatment (intervention group) and 287 were assigned to prompt infertility treatment for 24 months (control group). A total of 3 women withdrew consent, so 289 women in the intervention group and 285 women in the control group were included in the analysis. The discontinuation rate in the intervention group was 21.8%. In intention-to-treat analyses, the mean weight loss was 4.4 kg in the intervention group and 1.1 kg in the control group (P<0.001). The primary outcome occurred in 27.1% of the women in the intervention group and 35.2% of those in the control group (rate ratio in the intervention group, 0.77; 95% confidence interval, 0.60 to 0.99)., Conclusions: In obese infertile women, a lifestyle intervention preceding infertility treatment, as compared with prompt infertility treatment, did not result in higher rates of a vaginal birth of a healthy singleton at term within 24 months after randomization. (Funded by the Netherlands Organization for Health Research and Development; Netherlands Trial Register number, NTR1530.).
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- 2016
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45. A Randomized Trial of Progesterone in Women with Recurrent Miscarriages.
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Coomarasamy A, Williams H, Truchanowicz E, Seed PT, Small R, Quenby S, Gupta P, Dawood F, Koot YE, Bender Atik R, Bloemenkamp KW, Brady R, Briley AL, Cavallaro R, Cheong YC, Chu JJ, Eapen A, Ewies A, Hoek A, Kaaijk EM, Koks CA, Li TC, MacLean M, Mol BW, Moore J, Ross JA, Sharpe L, Stewart J, Vaithilingam N, Farquharson RG, Kilby MD, Khalaf Y, Goddijn M, Regan L, and Rai R
- Subjects
- Administration, Intravaginal, Adult, Body Mass Index, Double-Blind Method, Female, Gestational Age, Humans, Live Birth, Pregnancy, Pregnancy Trimester, First, Treatment Failure, Abortion, Habitual prevention & control, Progesterone therapeutic use
- Abstract
Background: Progesterone is essential for the maintenance of pregnancy. However, whether progesterone supplementation in the first trimester of pregnancy would increase the rate of live births among women with a history of unexplained recurrent miscarriages is uncertain., Methods: We conducted a multicenter, double-blind, placebo-controlled, randomized trial to investigate whether treatment with progesterone would increase the rates of live births and newborn survival among women with unexplained recurrent miscarriage. We randomly assigned women with recurrent miscarriages to receive twice-daily vaginal suppositories containing either 400 mg of micronized progesterone or matched placebo from a time soon after a positive urinary pregnancy test (and no later than 6 weeks of gestation) through 12 weeks of gestation. The primary outcome was live birth after 24 weeks of gestation., Results: A total of 1568 women were assessed for eligibility, and 836 of these women who conceived naturally within 1 year and remained willing to participate in the trial were randomly assigned to receive either progesterone (404 women) or placebo (432 women). The follow-up rate for the primary outcome was 98.8% (826 of 836 women). In an intention-to-treat analysis, the rate of live births was 65.8% (262 of 398 women) in the progesterone group and 63.3% (271 of 428 women) in the placebo group (relative rate, 1.04; 95% confidence interval [CI], 0.94 to 1.15; rate difference, 2.5 percentage points; 95% CI, -4.0 to 9.0). There were no significant between-group differences in the rate of adverse events., Conclusions: Progesterone therapy in the first trimester of pregnancy did not result in a significantly higher rate of live births among women with a history of unexplained recurrent miscarriages. (Funded by the United Kingdom National Institute of Health Research; PROMISE Current Controlled Trials number, ISRCTN92644181.).
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- 2015
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46. Patients' preferences for gonadotrophin-releasing hormone analogs in in vitro fertilization.
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van den Wijngaard L, van Wely M, Dancet EA, van Mello NM, Koks CA, van der Veen F, Mol BW, and Mochtar MH
- Subjects
- Female, Fertilization in Vitro psychology, Humans, Netherlands, Ovarian Hyperstimulation Syndrome chemically induced, Ovarian Hyperstimulation Syndrome prevention & control, Pregnancy, Pregnancy Rate, Surveys and Questionnaires, Treatment Outcome, Fertilization in Vitro adverse effects, Fertilization in Vitro methods, Gonadotropin-Releasing Hormone analogs & derivatives, Gonadotropin-Releasing Hormone antagonists & inhibitors, Patient Preference
- Abstract
Background: Gonadotrophin-releasing hormone (GnRH) antagonists reduce ovarian hyperstimulation syndrome (OHSS) at the price of a small reduction in effectiveness compared to GnRH agonists. The aim of this study was to investigate patients' preferences on effectiveness, safety and burden of GnRH analogs., Methods: A discrete choice experiment (DCE) and a trade-off question were designed. Patients embarking on assisted reproductive technique treatment were asked to choose between two hypothetical medications which differed in effectiveness, safety and burden., Results: A total of 172 questionnaires were analyzed. All attributes of the DCE had a statistically significant impact on the preference of the respondents. Respondents were willing to trade off 0.87 and 0.81% effectiveness for a decrease in OHSS risk and for fewer side effects, respectively. Respondents were not willing to trade off effectiveness for 'importance of compliance' (trade-off 0.40%) or a shorter 'duration of treatment' (trade-off 0.26%). The trade-off questions showed that already at a 2.0% increase in pregnancy rate in favor of the agonists, the majority of the respondents changed their preference from antagonists to agonists (2.0%, 95% CI 1.7-2.1)., Conclusion: Safety and burden are important to patients, but are not important enough to make up for a small decrease in pregnancy rate., (© 2014 S. Karger AG, Basel.)
- Published
- 2014
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47. The M-OVIN study: does switching treatment to FSH and / or IUI lead to higher pregnancy rates in a subset of women with world health organization type II anovulation not conceiving after six ovulatory cycles with clomiphene citrate - a randomised controlled trial.
- Author
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Nahuis MJ, Weiss NS, van der Veen F, Mol BW, Hompes PG, Oosterhuis J, Lambalk NB, Smeenk JM, Koks CA, van Golde RJ, Laven JS, Cohlen BJ, Fleischer K, Goverde AJ, Gerards MH, Klijn NF, Nekrui LC, van Rooij IA, Hoozemans DA, and van Wely M
- Subjects
- Anovulation complications, Clomiphene, Female, Humans, Infertility, Female etiology, Insemination, Artificial methods, Netherlands, Polycystic Ovary Syndrome complications, Pregnancy, Pregnancy Rate, Time-to-Pregnancy, Treatment Outcome, Anovulation therapy, Follicle Stimulating Hormone therapeutic use, Gonadotropins therapeutic use, Infertility, Female therapy, Ovulation Induction methods, Polycystic Ovary Syndrome therapy
- Abstract
Background: Clomiphene citrate (CC) is first line treatment in women with World Health Organization (WHO) type II anovulation and polycystic ovary syndrome (PCOS). Whereas 60% to 85% of these women will ovulate on CC, only about one half will have conceived after six cycles. If women do not conceive, treatment can be continued with gonadotropins or intra-uterine insemination (IUI). At present, it is unclear for how many cycles ovulation induction with CC should be repeated, and when to switch to ovulation induction with gonadotropins and/or IUI., Methods/design: We started a multicenter randomised controlled trial in the Netherlands comparing six cycles of CC plus intercourse or six cycles of gonadotrophins plus intercourse or six cycles of CC plus IUI or six cycles of gonadotrophins plus IUI.Women with WHO type II anovulation who ovulate but did not conceive after six ovulatory cycles of CC with a maximum of 150 mg daily for five days will be included.Our primary outcome is birth of a healthy child resulting from a pregnancy that was established in the first eight months after randomisation. Secondary outcomes are clinical pregnancy, miscarriage, multiple pregnancy and treatment costs. The analysis will be performed according to the intention to treat principle. Two comparisons will be made, one in which CC is compared to gonadotrophins and one in which the addition of IUI is compared to ovulation induction only. Assuming a live birth rate of 40% after CC, 55% after addition of IUI and 55% after ovulation induction with gonadotrophins, with an alpha of 5% and a power of 80%, we need to recruit 200 women per arm (800 women in total).An independent Data and Safety Monitoring Committee has criticized the data of the first 150 women and concluded that a sample size re-estimation should be performed after including 320 patients (i.e. 80 per arm)., Discussion: The trial will provide evidence on the most effective, safest and most cost effective treatment in women with WHO type II anovulation who do not conceive after six ovulatory cycles with CC with a maximum of 150 mg daily for five days. This evidence could imply the need for changing our guidelines, which may cause a shift in large practice variation to evidence based primary treatment for these women., Trial Registration Number: Netherlands Trial register NTR1449.
- Published
- 2013
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48. The value of chromosomal analysis in oligozoospermic men.
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Stegen Ç, van Rumste MM, Mol BW, and Koks CA
- Subjects
- Adult, Genetic Testing statistics & numerical data, Humans, Karyotyping statistics & numerical data, Male, Middle Aged, Netherlands epidemiology, Prevalence, Risk Factors, Young Adult, Chromosome Aberrations statistics & numerical data, Chromosome Disorders epidemiology, Chromosome Disorders genetics, Genetic Predisposition to Disease epidemiology, Genetic Predisposition to Disease genetics, Oligospermia epidemiology, Oligospermia genetics
- Abstract
Objective: To determine the prevalence of chromosomal abnormalities in relation to sperm concentration in subfertile oligozoospermic men., Design: Retrospective cohort study., Setting: Two teaching hospitals., Patient(s): We retrospectively studied all men who received chromosomal analysis prior to intracytoplasmic sperm injection (ICSI) treatment from 2000 to 2010 in two teaching hospitals., Intervention(s): None., Main Outcome Measure(s): The results of chromosomal analysis and semen analysis were recorded. The frequency of abnormal karyotypes was analyzed in relation to the sperm concentration, categorized as extreme oligozoospermia (>0 to ≤1 million/mL), severe oligozoospermia (>1 to ≤5 million/mL), moderate oligozoospermia (>5 to ≤20 million/mL), or normospermia (>20 million/mL)., Result(s): Among 582 male ICSI candidates, the rates of abnormal karyotypes were 1.2% (2/162), 2.2% (5/227), and 1.5% (2/130) for men with extreme, severe, and moderate oligozoospermia, respectively. No abnormalities were present in normospermic men., Conclusion(s): The risk of conceiving a viable child with unbalanced structural chromosomal abnormalities in men with oligozoospermia may not justify karyotyping., (Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)
- Published
- 2012
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49. Pregnancy outcomes and prognostic factors from tubal sterilization reversal by sutureless laparoscopical re-anastomosis: a retrospective cohort study.
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Schepens JJ, Mol BW, Wiegerinck MA, Houterman S, and Koks CA
- Subjects
- Adult, Cohort Studies, Fallopian Tubes surgery, Female, Humans, Laparoscopy, Pregnancy, Prognosis, Retrospective Studies, Sterilization, Tubal methods, Pregnancy Outcome, Sterilization Reversal methods
- Abstract
Background: Female sterilization is a widely used contraceptive method but in a small group of women, post-sterilization regret occurs. A dilemma for these women is the choice between surgical re-anastomosis and IVF. We evaluated the factors that affected pregnancy rate after laparoscopic tubal re-anastomosis for sterilization regret., Methods: We included women who underwent a laparoscopic tubal re-anastomosis between January 1997 and March 2008 at Máxima Medical Centre, The Netherlands, in a retrospective cohort study. Microsurgical laparoscopic re-anastomosis was performed using a serosa-muscular fixation/biological glue technique. The primary outcome was time to clinical pregnancy (TTP). Other outcomes were ongoing pregnancy and ectopic pregnancy. We studied whether clinical characteristics, including age, fertility history, BMI, semen quality, remaining tubal length and type of anastomosis, could predict the chance of pregnancy., Results: Data from 127 patients were analysed. The 40-month cumulative clinical pregnancy rate was 74%, whereas the ongoing pregnancy rate was 59%. There were five ectopic pregnancies (3.9%). Only age was found to influence the probability of a positive pregnancy test, hazard rate ratio (HRR): 0.32 [95% confidence interval (CI) 0.12-0.88] and ongoing pregnancy [HRR 0.21 (95% CI 0.05-0.87)]. Previous pregnancy increased pregnancy probability [HRR: 2.2 (95% CI 0.51-9.8)]. A total sperm motility count of <20 million was related to prolonged TTP., Conclusions: Sutureless laparoscopic tubal re-anastomosis is an effective treatment for women who regret sterilization. Age, previous pregnancies and sperm quality should be considered when counselling for tubal sterilization reversal versus IVF. A randomized prospective trial comparing success rates of surgical reversal and IVF after sterilization regret should be conducted.
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- 2011
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50. The LIFESTYLE study: costs and effects of a structured lifestyle program in overweight and obese subfertile women to reduce the need for fertility treatment and improve reproductive outcome. A randomised controlled trial.
- Author
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Mutsaerts MA, Groen H, ter Bogt NC, Bolster JH, Land JA, Bemelmans WJ, Kuchenbecker WK, Hompes PG, Macklon NS, Stolk RP, van der Veen F, Maas JW, Klijn NF, Kaaijk EM, Oosterhuis GJ, Bouckaert PX, Schierbeek JM, van Kasteren YM, Nap AW, Broekmans FJ, Brinkhuis EA, Koks CA, Burggraaff JM, Blankhart AS, Perquin DA, Gerards MH, Mulder RJ, Gondrie ET, Mol BW, and Hoek A
- Subjects
- Adolescent, Adult, Body Mass Index, Diet, Female, Humans, Infertility, Female etiology, Infertility, Female prevention & control, Motor Activity, Obesity prevention & control, Overweight complications, Overweight prevention & control, Overweight therapy, Pregnancy, Pregnancy Complications etiology, Pregnancy Complications prevention & control, Pregnancy Outcome, Weight Loss physiology, Young Adult, Infertility, Female therapy, Life Style, Obesity complications, Obesity therapy
- Abstract
Background: In the Netherlands, 30% of subfertile women are overweight or obese, and at present there is no agreement on fertility care for them. Data from observational and small intervention studies suggest that reduction of weight will increase the chances of conception, decrease pregnancy complications and improve perinatal outcome, but this has not been confirmed in randomised controlled trials. This study will assess the cost and effects of a six-months structured lifestyle program aiming at weight reduction followed by conventional fertility care (intervention group) as compared to conventional fertility care only (control group) in overweight and obese subfertile women. We hypothesize that the intervention will decrease the need for fertility treatment, diminish overweight-related pregnancy complications, and will improve perinatal outcome., Methods/design: Multicenter randomised controlled trial in subfertile women (age 18-39 year) with a body mass index between 29 and 40 kg/m2. Exclusion criteria are azoospermia, use of donor semen, severe endometriosis, premature ovarian failure, endocrinopathies or pre-existent hypertensive disorders.In the intervention group the aim is a weight loss of at least 5% to10% in a six-month period, to be achieved by the combination of a diet, increase of physical activity and behavioural modification. After six months, in case no conception has been achieved, these patients will start fertility treatment according to the Dutch fertility guidelines. In the control group treatment will be started according to Dutch fertility guidelines, independently of the patient's weight., Outcome Measures and Analysis: The primary outcome measure is a healthy singleton born after at least 37 weeks of gestation after vaginal delivery. Secondary outcome parameters including pregnancy outcome and complications, percentage of women needing fertility treatment, clinical and ongoing pregnancy rates, body weight, quality of life and costs.Data will be analysed according to the intention to treat principle, and cost-effectiveness analysis will be performed to compare the costs and health effects in the intervention and control group., Discussion: The trial will provide evidence for costs and effects of a lifestyle intervention aiming at weight reduction in overweight and obese subfertile women and will offer guidance to clinicians for the treatment of these patients., Trial Registration: Dutch Trial Register NTR1530.
- Published
- 2010
- Full Text
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