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Objective:Birth weight, fetal growth and placental function influence cognitive development. The gradient of these associations is understudied, especially among those with a birth weight considered appropriate-for-gestational age. The aim of this study was to evaluate the associations between birth-weight centile and intellectual development in term/near-term infants across the entire birth-weight spectrum, in order to provide a basis for better understanding of the long-term implications of fetal growth restriction and reduced placental function.Methods:This was a population-based cohort study of 266 440 liveborn singletons from uncomplicated pregnancies, delivered between 36 and 42 weeks of gestation. Perinatal data were obtained from the Dutch Perinatal Registry over the period 2003–2008 and educational data for children aged approximately 12 years were obtained from Statistics Netherlands over the period 2016–2019. Regression analyses were conducted to assess the association of birth-weight centile with school performance. The primary outcomes were mean school performance score, on a scale of 501–550, and proportion of children who reached higher secondary school level.Results:Mean school performance score increased gradually with increasing birth-weight centile, from 533.6 in the 1st–5th birth-weight-centile group to 536.8 in the 81st–85th birth-weight-centile group. Likewise, the proportion of children at higher secondary school level increased with birth-weight centile, from 43% to 57%. Compared with the 81st–85th birth-weight-centile group, mean school performance score and proportion of children at higher secondary school level were significantly lower in all birth-weight-centile groups below the 80th centile, after adjusting for confounding factors.Conclusions:Birth-weight centile is associated positively with school performance at 12 years of age across the entire birth-weight spectrum, well beyond the conventional and arbitrary cut-offs for suspected fetal growth restriction. This underlines the importance of developing better tools to diagnose fetal growth restriction and reduced placental function, and to identify those at risk for associated short- and long-term consequences. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

INTRODUCTION: Heavy menstrual bleeding (HMB) affects a quarter of all women, with half having no structural cause. Dutch guidelines recommend a stepped care approach to the management of such idiopathic HMB, starting with medication or a levonorgestrel-releasing intrauterine device (LNG-IUD), before progressing to endometrial ablation, and ultimately, hysterectomy. However, practice variation between hospitals could lead to suboptimal health outcomes and increased healthcare costs for some women.OBJECTIVES: To evaluate adherence to stepped care for women with idiopathic HMB and to identify practice variation among Dutch hospitals.STUDY DESIGN: This population-based cross-sectional study used Dutch insurance claims data from primary and secondary care for all women with idiopathic HMB referred to a gynecologist between January 2019 and December 2020. We calculated the average number of treatments in the 3 years before each treatment step at each hospital, making adjustments for age, socioeconomic status, and ethnicity. Variation in medical practice was measured by the coefficient of variation (CV).RESULTS: We studied 20,715 women treated with LNG-IUDs (56%), endometrial ablation (36%), laparoscopic hysterectomy (13%), or vaginal hysterectomy (4%) in 93 hospitals. Before endometrial ablation, on average 47% used medication (hospital range 27%-71%; CV 0.17) and 16% used an LNG-IUD (hospital range 8%-29%, CV 0.32). Before hysterectomy, 52% (hospital range 28%-65%, CV 0.16) used medication, 21% (hospital range 6%-38%, CV 0.35) used an LNG-IUD, and 23% underwent endometrial ablation (hospital range 0%-59%, CV 0.55). On average, women underwent 0.63 (hospital range 0.36-1.00, adjusted rate 0.40-0.98, CV 0.17) and 0.96 (hospital range 0.56-1.45, adjusted rate 0.56-1.44, CV 0.18) treatments before endometrial ablation and hysterectomy, respectively.CONCLUSIONS: Considerable practice variation exists among Dutch hospitals in the stepped care approach to idiopathic HMB. Improving adherence to this approach could improve quality of care and reduce costs.

STUDY QUESTIONWhat are the long-term outcomes after allocation to use of gonadotrophins versus clomiphene citrate (CC) with or without IUI in women with normogonadotropic anovulation and clomiphene failure?SUMMARY ANSWERAbout four in five women with normogonadotropic anovulation and CC failure had a live birth, with no evidence of a difference in pregnancy outcomes between the allocated groups.WHAT IS KNOWN ALREADYCC has long been used as first line treatment for ovulation induction in women with normogonadotropic anovulation. Between 2009 and 2015, a two-by-two factorial multicentre randomized clinical trial in 666 women with normogonadotropic anovulation and six cycles of CC failure was performed (M-ovin trial). This study compared a switch to gonadotrophins with continued treatment with CC for another six cycles, with or without IUI within 8 months. Switching to gonadotrophins increased the chance of conception leading to live birth by 11% over continued treatment with CC after six failed ovulatory cycles, at a cost of €15 258 per additional live birth. The addition of IUI did not significantly increase live birth rates.STUDY DESIGN, SIZE, DURATIONIn order to investigate the long-term outcomes of switching to gonadotrophins versus continuing treatment with CC, and undergoing IUI versus continuing with intercourse, we conducted a follow-up study. The study population comprised all women who participated in the M-ovin trial.PARTICIPANTS/MATERIALS, SETTING, METHODSThe participating women were asked to complete a web-based questionnaire. The primary outcome of this study was cumulative live birth. Secondary outcomes included clinical pregnancies, multiple pregnancies, miscarriage, stillbirth, ectopic pregnancy, fertility treatments, neonatal outcomes and pregnancy complications.MAIN RESULTS AND THE ROLE OF CHANCEWe approached 564 women (85%), of whom 374 (66%) responded (184 allocated to gonadotrophins; 190 to CC). After a median follow-up time of 8 years, 154 women in the gonadotrophin group had a live birth (83.7%) versus 150 women in the CC group (78.9%) (relative risk (RR) 1.06, 95% CI 0.96–1.17). A second live birth occurred in 85 of 184 women (49.0%) in the gonadotrophin group and in 85 of 190 women (44.7%) in the CC group (RR 1.03, 95% CI 0.83–1.29). Women allocated to gonadotrophins had a third live birth in 6 of 184 women (3.3%) and women allocated to CC had a third live birth in 14 of 190 women (7.4%). There were respectively 12 and 11 twins in the gonadotrophin and CC groups. The use of fertility treatments in the follow-up period was comparable between both groups. In the IUI group, a first live birth occurred in 158 of 192 women (82.3%) and while in the intercourse group, 146 of 182 women (80.2%) reached at least one live birth (RR: 1.03 95% CI 0.93–1.13; 2.13%, 95% CI −5.95, 10.21).LIMITATIONS, REASONS FOR CAUTIONWe have complete follow-up results for 57% of the women.There were 185 women who did not respond to the questionnaire, while 102 women had not been approached due to missing contact details. Five women had not started the original trial.WIDER IMPLICATIONS OF THE FINDINGSWomen with normogonadotropic anovulation and CC failure have a high chance of reaching at least one live birth. In terms of pregnancy rates, the long-term differences between initially switching to gonadotrophins are small compared to continuing treatment with CC.STUDY FUNDING/COMPETING INTEREST(S)The original study received funding from the Dutch Organization for Health Research and Development (ZonMw number: 80-82310-97-12067). A.H. reports consultancy for development and implementation of a lifestyle App, MyFertiCoach, developed by Ferring Pharmaceutical Company. M.G. receives unrestricted grants for scientific research and education from Ferring, Merck and Guerbet. B.W.M. is supported by an NHMRC Investigatorgrant (GNT1176437). B.W.M. reports consultancy for ObsEva and Merck and travel support from Merck. All other authors have nothing to declare.TRIAL REGISTRATION NUMBERThis follow-up study was registered in the OSF Register, https://osf.io/pf24m. The original M-ovin trial was registered in the Netherlands Trial Register, number NTR1449.

BACKGROUND Several GnRH antagonist protocols are currently used during COS in the context of ART treatments; however, questions remain regarding whether these protocols are comparable in terms of efficacy and safety. OBJECTIVE AND RATIONALE A systematic review followed by a pairwise and network meta-analyses were performed. The systematic review and pairwise meta-analysis of direct comparative data according to the PRISMA guidelines evaluated the effectiveness of different GnRH antagonist protocols (fixed Day 5/6 versus flexible, ganirelix versus cetrorelix, with or without hormonal pretreatment) on the probability of live birth and ongoing pregnancy after COS during ART treatment. A frequentist network meta-analysis combining direct and indirect comparisons (using the long GnRH agonist protocol as the comparator) was also performed to enhance the precision of the estimates. SEARCH METHODS The systematic literature search was performed using Embase (Ovid), MEDLINE (Ovid), Cochrane Central Register of Trials (CENTRAL), SCOPUS and Web of Science (WOS), from inception until 23 November 2021. The search terms comprised three different MeSH terms that should be present in the identified studies: GnRH antagonist; assisted reproduction treatment; randomized controlled trial (RCT). Only studies published in English were included. OUTCOMES The search strategy resulted in 6738 individual publications, of which 102 were included in the systematic review (corresponding to 75 unique studies) and 73 were included in the meta-analysis. Most studies were of low quality. One study compared a flexible protocol with a fixed Day 5 protocol and the remaining RCTs with a fixed Day 6 protocol. There was a lack of data regarding live birth when comparing the flexible and fixed GnRH antagonist protocols or cetrorelix and ganirelix. No significant difference in live birth rate was observed between the different pretreatment regimens versus no pretreatment or between the different pretreatment protocols. A flexible GnRH antagonist protocol resulted in a significantly lower OPR compared with a fixed Day 5/6 protocol (relative risk (RR) 0.76, 95% CI 0.62 to 0.94, I2 = 0%; 6 RCTs; n = 907 participants; low certainty evidence). There were insufficient data for a comparison of cetrorelix and ganirelix for OPR. OCP pretreatment was associated with a lower OPR compared with no pretreatment intervention (RR 0.79, 95% CI 0.69 to 0.92; I2 = 0%; 5 RCTs, n = 1318 participants; low certainty evidence). Furthermore, in the network meta-analysis, a fixed protocol with OCP resulted in a significantly lower OPR than a fixed protocol with no pretreatment (RR 0.84, 95% CI 0.71 to 0.99; moderate quality evidence). The surface under the cumulative ranking (SUCRA) scores suggested that the fixed protocol with no pretreatment is the antagonist protocol most likely (84%) to result in the highest OPR. There was insufficient evidence of a difference between fixed/flexible or OCP pretreatment/no pretreatment interventions regarding other outcomes, such as ovarian hyperstimulation syndrome and miscarriage rates. WIDER IMPLICATIONS Available evidence, mostly of low quality and certainty, suggests that different antagonist protocols should not be considered as equivalent for clinical decision-making. More trials are required to assess the comparative effectiveness of ganirelix versus cetrorelix, the effect of different pretreatment interventions (e.g. progestins or oestradiol) or the effect of different criteria for initiation of the antagonist in the flexible protocol. Furthermore, more studies are required examining the optimal GnRH antagonist protocol in women with high or low response to ovarian stimulation.

To verify the accuracy of an online algorithm using Bayes' theorem for diagnosing ectopic pregnancy (EP) using human chorionic gonadotropin (hCG), ultrasound, and clinical data in a real cohort.A retrospective cohort study.Gynecologic emergency unit in a tertiary teaching hospital.First-trimester pregnant women who attended the gynecologic emergency unit for any reason. Those who had13 weeks of pregnancy confirmed by a recent positive pregnancy test; a digital image or electronic report of transvaginal ultrasound (TVUS) obtained from hospital database; and a follow-up with a pathology report or a clinical resolution of a confirmed pregnancy were included in the study. Clinical signs and symptoms, the presence of risk factors for EP, the TVUS findings in each consultation, and the hCG levels were independent variables obtained from the electronic medical records. From these data, the pretest probability, based on the clinical presentation and risk factors, and the likelihood ratio for each variable were calculated for their use in the algorithm, yielding a posttest probability.Not applicable.The accuracy of the online algorithm to identify cases of EP using clinical signs and symptoms, the presence of risk factors for EP, the TVUS findings in each consultation, and the hCG levels. The main outcome was EP, confirmed either by pathology report or by the presence of fetal heartbeat or gestational sac outside the uterine cavity.Between January 1, 2009 and December 27, 2016, 2,495 women were analyzed, and the algorithm was applied to 2,185 of them. The incidence of EP was 8.5% (212/2,495); 310 women were excluded because they were submitted to surgery with decision thresholds95%. The algorithm was applied to 2,185 women. Just one case remained inconclusive after 3 consultations, and it was considered as an error in prediction. The sensitivity, specificity, and accuracy values (95% confidence interval) of the algorithm were 98.9% (96.1%-99.8%), 98.9% (98.3%-99.2%), and 98.9% (98.3%-99.2%), respectively.The accuracy of the Bayesian algorithm to confirm or rule out EP is excellent. Online Nomogram https://docs.google.com/spreadsheets/d/1jStXlMBjbPyDf6_W0deKGKQLZHU5EFAe8rLhNVPuJuY/edit?usp=sharing.

To investigate the relationship between the embryo frozen time and live birth rate (LBR) in women having a freeze-all cycle.Retrospective cohort study.Academic hospital.Women who underwent their first vitrified-warmed cycles from January 2013 to December 2019.Embryo storage time.The primary outcome was the LBR.A total of 14,928 women were eligible for the analysis. Women with the frozen time of transferred embryos for 2-5 months were associated with a higher LBR compared with other groups. The results were confirmed by an inverted U curve in the restricted cubic splines before as well as after adjustment for covariables, which suggested that an embryo storage time of 3-4 months was associated with the highest LBR. Subgroup analyses demonstrated that the inverted U curve relationship between embryo storage time and LBR was only observed in women with the high response. Sensitivity analyses in women with at least one good-quality embryo for transfer, in women aged36 years at embryo transfer, or in women with double cleavage embryo transfer showed that the association remained valid. The association was weakened in women with single blastocyst transfer probably because of the small sample size in these women.An inverted U-shaped relationship was found between embryo storage time and treatment success in women with high ovarian response in freeze-all embryo transfer cycles. Prolonged storage time of6 months was associated with reduced pregnancy rates.

Worldwide reports have produced conflicting data on perinatal outcomes during the COVID-19 pandemic. This systematic review and meta-analysis addressed the effect of mitigation measures against COVID-19 on preterm birth, stillbirth, low birth weight, and NICU admission during the first nine months of the pandemic. A search was performed using MEDLINE, Embase and SCOPUS for manuscripts published up until 24th May 2021. Studies that reported perinatal outcomes (preterm birth, stillbirth, low birth weight, NICU admission) during the COVID-19 pandemic with a pre-pandemic control period were included. Risk of bias assessment was performed using ROBINS-I tool. RevMan5 was used to perform meta-analysis with random-effects models. A score of the stringency of mitigation measures was calculated from the Oxford COVID-19 Government Response Tracker. Thirty-eight studies of moderate to serious risk of bias were included, with varied methodology, analysis and regional mitigation measures, using stringency index scores. There was no overall effect on preterm birth at less than 37 weeks (OR 0.96, 95% CI 0.92-1.00). However, there was a reduction in preterm birth at less than 37 weeks (OR 0.89, 95% CI 0.81-0.98) and 34 weeks (OR 0.56, 95% CI 0.37-0.83) for iatrogenic births and in singleton pregnancies. There was also a significant reduction in preterm births at less than 34 weeks in studies with above median stringency index scores (OR 0.71, 95% CI 0.58-0.88). There was no effect on risk of stillbirth (OR 1.04, 95% CI 0.90-1.19) or birth weight. NICU admission rates were significantly reduced in studies with above median stringency index scores (OR 0.87, 95% CI 0.78-0.97). The reduction in preterm births in regions with high mitigation measures against SARS-CoV-2 infection is likely driven by a reduction in iatrogenic births. Variability in study design and cohort characteristics need to be considered for future studies to allow further investigation of population level health measures of perinatal outcomes.

STUDY QUESTION What is the capacity of the change between Day 1 and Day 4 post-treatment serum human chorionic gonadotropin (hCG) levels for predicting single-dose methotrexate treatment success in tubal ectopic pregnancy? SUMMARY ANSWER Any fall in Days 1–4 serum hCG signified an 85% (95% CI 76.8–90.6) likelihood of treatment success for women with tubal ectopic pregnancy (initial hCG of ≥1000 and ≤5000 IU/l) managed with single-dose methotrexate. WHAT IS KNOWN ALREADY For those with tubal ectopic pregnancy managed by single-dose methotrexate, current guidelines advocate intervention if Days 4–7 hCG fails to fall by >15%. The trajectory of hCG over Days 1–4 has been proposed as an early indicator that predicts treatment success, allowing early reassurance for women. However, almost all prior studies of Days 1–4 hCG changes have been retrospective. STUDY DESIGN, SIZE, DURATION This was a prospective cohort study of women with tubal ectopic pregnancy (pre-treatment hCG of ≥1000 and ≤5000 IU/l) managed with single-dose methotrexate. The data were derived from a UK multicentre randomized controlled trial of methotrexate and gefitinib versus methotrexate and placebo for treatment of tubal ectopic pregnancy (GEM3). For this analysis, we include data from both treatment arms. PARTICIPANTS/MATERIALS, SETTING, METHODS Participants were categorized according to single-dose methotrexate treatment success or failure. Treatment success for this analysis was defined as complete and uneventful resolution of tubal ectopic pregnancy to serum hCG MAIN RESULTS AND THE ROLE OF CHANCE A total of 322 women with tubal ectopic pregnancy were treated with single-dose methotrexate. The overall single-dose methotrexate treatment success rate was 59% (n = 189/322). For any fall in serum hCG on Days 1–4, likelihood ratios were >3, while for any fall of serum hCG >20% on Days 1–7, likelihood ratios reached 5. Any rise of serum hCG on Days 1–7 and 4–7 strongly reduced the chance of success. Any fall in Days 1–4 hCG predicted single-dose methotrexate treatment success with a sensitivity of 58% and specificity 84%, resulting in positive and negative predictive values of 85% and 57%, respectively. Any rise in Days 1–4 serum hCG LIMITATIONS, REASONS FOR CAUTION Our findings may be limited by intervention bias resulting from existing guidelines which influences evaluation of hCG changes reliant on Day 7 serum hCG levels. WIDER IMPLICATIONS OF THE FINDINGS Examining a large prospective cohort, we show the value of Days 1–4 serum hCG changes in predicting single-dose methotrexate treatment success in tubal ectopic pregnancy. We recommend that clinicians provide early reassurance to women who have a fall or only a modest ( STUDY FUNDING/COMPETING INTEREST(S) This project was supported by funding from the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research partnership (grant reference number 14/150/03). A.W.H. has received honoraria for consultancy for Ferring, Roche, Nordic Pharma and AbbVie. W.C.D. has received honoraria from Merck and Guerbet and research funding from Galvani Biosciences. L.H.R.W. has received research funding from Roche Diagnostics. B.W.M. is supported by a NHMRC Investigator grant (GNT1176437). B.W.M. also reports consultancy for ObsEva and Merck and travel support from Merck. The other authors declare no competing interests. TRIAL REGISTRATION NUMBER This study is a secondary analysis of the GEM3 trial (ISRCTN Registry ISRCTN67795930).

Objective: To determine whether hysteroscopic niche resection (HNR) and expectant management are suitable in women with fertility desire and a niche with a residual myometrium thickness (RMT) ≥ 2.5 mm. Study design: This retrospective cohort study was conducted at International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China between September 2016 and December 2021. We reported the fertility outcomes between women (with fertility desire and a niche with RMT ≥ 2.5 mm) who received HNR or expectant management. Results: We studied 166 women, of whom 72 accepted HNR and 94 accepted expectant management. The HNR group included more symptomatic women, in terms of postmenstrual spotting or infertility. No differences were found regarding niche measures before treatment. The live birth rate was comparable in both groups (HNR versus expectant management as 55.5% versus 45.7%, risk ratio = 1.48, 95% Cl 0.80–2.75, p = 0.21). The pregnancy rate was higher in HNR group than that in expectant management group (n = 72.2% versus n = 56.4%, risk ratio = 2.01, 95% CI 1.04–3.88, p = 0.04). In a subgroup of women with infertility before entry in the study, HNR resulted in a significant higher live birth rate (p = 0.04) and pregnancy rate (p = 0.01). Conclusion: In women with infertility with a symptomatic niche with RMT ≥ 2.5 mm, HNR may be superior to expectant management. This retrospective cohort biased selection against a randomized study, our results still need to be validated in the future with larger clinical multicenter randomized controlled trials.

To assess the performance of placental, fetal and maternal cardiovascular markers in the prediction of adverse perinatal and maternal outcomes in women with suspected or confirmed pre-eclampsia.This was a prospective prognostic accuracy study of women with suspected or confirmed pre-eclampsia who underwent a series of investigations to measure maternal hemodynamic indices, mean arterial pressure, augmentation index, ophthalmic artery peak systolic velocity (PSV) ratio, uterine artery pulsatility index (UtA-PI), fetal biometric and Doppler parameters, soluble fms-like tyrosine kinase-1 (sFlt-1) and placental growth factor (PlGF). The performance of these markers, individually or in combination, in predicting adverse perinatal and maternal outcomes was then assessed using receiver-operating-characteristics (ROC)-curve analysis. Adverse maternal outcome was defined as one or more of severe hypertension, admission to the intensive care unit, eclampsia, placental abruption, HELLP syndrome, disseminated intravascular coagulation, platelets 100 × 10We recruited 126 women with suspected (n = 31) or confirmed (n = 95) pre-eclampsia at a median gestational age of 33.9 weeks (interquartile range, 30.9-36.3 weeks). Pregnancies with adverse perinatal outcome compared to those without had a higher median UtA-PI (1.3 vs 0.8; P 0.001), ophthalmic artery PSV ratio (0.8 vs 0.7; P = 0.01) and umbilical artery PI percentile (82.0 vs 68.5; P 0.01) and lower median estimated fetal weight percentile (4.0 vs 43.0; P 0.001), abdominal circumference percentile (4.0 vs 63.0; P 0.001), middle cerebral artery PI percentile (28.0 vs 58.5; P 0.001) and cerebroplacental ratio percentile (18.0 vs 46.5; P 0.001). Pregnancies with adverse perinatal outcome also had a higher median sFlt-1 (8208.0 pg/mL vs 4508.0 pg/mL; P 0.001), lower PlGF (27.2 pg/mL vs 76.3 pg/mL; P 0.001) and a higher sFlt-1/PlGF ratio (445.4 vs 74.4; P 0.001). The best performing individual marker for predicting adverse perinatal outcome was the sFlt-1/PlGF ratio (area under the ROC curve (AUC), 0.87 (95% CI, 0.81-0.93)), followed by estimated fetal weight (AUC, 0.81 (95% CI, 0.73-0.89)). Women who experienced adverse maternal outcome had a higher median sFlt-1 level (7471.0 pg/mL vs 5131.0 pg/mL; P 0.001) and sFlt-1/PlGF ratio (204.3 vs 93.3; P 0.001) and a lower PlGF level (37.0 pg/mL vs 66.1 pg/mL; P = 0.01) and estimated fetal weight percentile (16.5 vs 37.0; P = 0.04). All markers performed poorly in predicting adverse maternal outcome, with sFlt-1 (AUC, 0.69 (95% CI, 0.60-0.79)) and sFlt-1/PlGF ratio (AUC, 0.69 (95% CI, 0.59-0.78)) demonstrating the best individual performance. The addition of cardiovascular, fetal or other placental indices to the sFlt-1/PlGF ratio did not improve the prediction of adverse maternal or perinatal outcomes.The sFlt-1/PlGF ratio performs well in predicting adverse perinatal outcomes but is a poor predictor of adverse maternal outcomes in women with suspected or diagnosed pre-eclampsia. The addition of cardiovascular or fetal indices to the model is unlikely to improve the prognostic performance of the sFlt-1/PlGF ratio. © 2022 International Society of Ultrasound in Obstetrics and Gynecology.

STUDY QUESTION What is the impact of uterine malformations on reproductive and neonatal outcomes of IVF/ICSI–frozen embryo transfer? SUMMARY ANSWER Unification defective uteri are associated with poorer neonatal outcomes including higher preterm delivery rate and lower birthweight, and septate uteri are associated with worse fertility outcomes including higher miscarriage and lower live birth rates (LBRs). WHAT IS KNOWN ALREADY Several studies have investigated the negative effects of uterine malformations on pregnancy outcomes. However, an all-round and definitive conclusion has not been reached yet owing to the relatively low incidence of the disease and the heterogeneity of study populations, especially among women undergoing ART. STUDY DESIGN, SIZE, DURATION This was a retrospective cohort study including 411 women with congenital uterine anomalies and 14 936 women with a normal uterus who underwent first frozen-thawed embryo transfer cycles of IVF/ICSI from July 2008 to August 2019. We compared reproductive outcomes. PARTICIPANTS/MATERIALS, SETTING, METHODS Reproductive outcomes of women with uterine malformations were studied through three propensity score-matched comparisons (patients with bicorporeal uterus, septate uterus and hemi-uterus [bicorporeal, septate and hemi-uterus groups, respectively] along with corresponding control groups without uterine malformations). We also compared pregnancy and neonatal outcomes, and performed subgroup analysis addressing didelphus, bicornuate uteri and septate uteri before and after surgery independently. MAIN RESULTS AND THE ROLE OF CHANCE Compared to the matched control group, women with a bicorporeal uterus had a significantly lower LBR (24.4% versus 34.8%, odds ratio (OR) 0.61 [95% CI: 0.37, 1.00], P = 0.048). The incidence of miscarriage and preterm delivery was higher but not statistically significant (29.0% versus 18.1%, OR 1.85 [95% CI: 0.82, 4.19], P = 0.135; 22.6% versus 9.9%, OR 2.64 [95% CI: 1.07, 6.52], P = 0.063, respectively). In addition, the bicorporeal group had a significantly lower gestational age, higher caesarean rate and lower birthweight than bicorporeal control. Women with a septate uterus had comparable clinical pregnancy rates to controls (43.3% versus 49.9%, OR 0.77 [95% CI: 0.57, 1.04], P = 0.091), increased miscarriage rates (23.5% versus 13.0%, OR 2.05 [95% CI: 1.18, 3.58], P = 0.010) and lower LBRs (29.4% versus 42.2%, OR 0.57 [95% CI: 0.41, 0.79], P = 0.001). In both singleton and twins pregnancies, pregnancy and neonatal outcomes were comparable between women with a septate uterus and control. Women with a hemi-uterus had a tendency for lower clinical pregnancy rate (36.8% versus 42.3%, OR 0.80 [95% CI: 0.52, 1.21], P = 0.287) and LBR (29.8% versus 33.1%, OR 0.86 [95% CI: 0.55, 1.34], P = 0.502), compared to women without malformations. The incidences of miscarriage and preterm delivery, respectively, were 16.7% versus 16.6% (OR 1.01 [95% CI: 0.41, 2.47], P = 0.989), and 9.5% versus 11.4% (OR 0.82 [95% CI: 0.27, 2.51], P = 1) in women with a hemi-uterus as compared to control. LIMITATIONS, REASONS FOR CAUTION This was a single-centre, retrospective study in which neonatal data were extracted from parental questionnaires. The information on uteri septum type and surgery methods was poorly presented, with limited detail. In patients with uterine malformations, the number of babies with birth defects and twin pregnancies was relatively small, limiting the power of the study. WIDER IMPLICATIONS OF THE FINDINGS Compared to patients with a normal uterus, women with uterine malformation have poorer reproductive outcomes. Pregnant women with a uterine anomaly need to be managed as high-risk pregnancies and followed with appropriate obstetric review. STUDY FUNDING/COMPETING INTEREST(S) This work was supported by the National Ministry of Technology (2018YFC1003000), the Elite Team Project of Ninth People’s Hospital affiliated to Shanghai Jiao Tong University School of Medicine (JY201801), Shanghai Sailing Program (21YF1423200) and the Fundamental Research Program Funding of Ninth People’s Hospital affiliated to Shanghai Jiao Tong University School of Medicine (JYZZ117). B.W.M. is supported by an NHMRC Investigatorgrant (GNT1176437). B.W.M. reports consultancy (with stock options) for ObsEva. B.W.M. has received research funding from Ferring and Merck. The authors declare no other competing interests. TRIAL REGISTRATION NUMBER N/A.

BackgroundRandomised controlled trials (RCTs) evaluating ectopic pregnancy have different outcomes which are defined and measured in diverse ways, which limits their ability to inform evidence-based clinical practice.ObjectiveTo address methodological deficiencies in published RCTs and systematic reviews, this study has developed a core outcome set to guide future research in ectopic pregnancy.DesignTo identify potential outcomes, we performed a comprehensive literature review and interviews with individuals with lived experience in ectopic pregnancy. Potential core outcomes were then entered into a three-round Delphi survey. 154 participants from six continents, comprising healthcare professionals, researchers, and individuals with lived experience in ectopic pregnancy, completed all three rounds of the Delphi survey. Outcomes were prioritised at three consensus development meetings and recommendations were developed on how to report these outcomes where possible.SubjectsHealthcare professionals, researchers, and individuals with lived experience in ectopic pregnancyResultsSix outcomes reached full consensus, including treatment success, resolution time, number of additional interventions, adverse events, mortality and severe morbidity, and treatment satisfaction.ConclusionThe core outcome set with six outcomes for ectopic pregnancy will help standardise reporting of clinical trials, facilitate implementation of findings into clinical practice, and enhance patient centred care.

STUDY QUESTION Is there any difference in developmental outcomes in children born after capacitation IVM (CAPA IVM) compared with conventional IVF? SUMMARY ANSWER Overall development up to 24 months of age was comparable in children born after CAPA IVM compared with IVF. WHAT IS KNOWN ALREADY IVM has been shown to be a feasible alternative to conventional IVF in women with a high antral follicle count (AFC). In addition to live birth rate, childhood development is also a relevant metric to compare between the two approaches to ART and there are currently no data on this. STUDY DESIGN, SIZE, DURATION This study was a follow-up of babies born to women who participated in a randomized controlled trial comparing IVM with a pre-maturation step (CAPA IVM) and IVF. Developmental assessments were performed on 231 children over 24 months of follow-up. PARTICIPANTS/MATERIALS, SETTING, METHODS Participants in the randomized controlled trial had an indication for ART and a high AFC (≥24 follicles in both ovaries). They were randomized to undergo one cycle of either IVM (n = 273) or IVF (n = 273). Of these, 96 women and 118 women, respectively, had live births. Seventy-six women (94 children, 79.2%) and 104 women (137 children, 88.1%), respectively, completed Ages & Stages Third Edition Questionnaire assessment (ASQ-3), and underwent evaluation of Developmental Red Flags at 6, 12 and 24 months of age. MAIN RESULTS AND THE ROLE OF CHANCE Baseline characteristics of participants in the follow-up study between the IVM and IVF groups were comparable. Overall, there were no significant differences in ASQ-3 scores at 6, 12 and 24 months between children born after IVM or IVF. The proportion of children with developmental red flags was low and did not differ between the two groups. Slightly, but significantly, lower ASQ-3 problem solving and personal–social scores in twins from the IVM versus IVF group at 6 months were still within the normal range and had caught up to the IVF group in the 12- and 24-month assessments. The number of children confirmed to have abnormal mental and/or motor development after specialist assessment was four in the IVM group and two in the IVF group (relative risk 2.91, 95% CI 0.54–15.6; P = 0.23). LIMITATIONS, REASONS FOR CAUTION This study is an open-label follow-up of participants in a randomized controlled trial, and not all original trial subjects took part in the follow-up. The self-selected nature of the follow-up population could have introduced bias, and the sample size may have been insufficient to detect significant between-group differences in developmental outcomes. WIDER IMPLICATIONS OF THE FINDINGS Based on the current findings at 2 years of follow-up, there does not appear to be any significant concern about the effects of IVM on childhood development. These data add to the evidence available to physicians when considering different approaches to fertility treatment, but require validation in larger studies. STUDY FUNDING/COMPETING INTEREST(S) This work was funded by the Vietnam National Foundation for Science and Technology Development (NAFOSTED) under grant number FWO.106-YS.2017.02. L.N.V. has received speaker and conference fees from Merck, grant, speaker and conference fees from Merck Sharpe and Dohme, and speaker, conference and scientific board fees from Ferring; T.M.H. has received speaker fees from Merck, Merck Sharp and Dohme, and Ferring; R.J.N. has receives grant funding from the National Health and Medical Research Council (NHMRC) of Australia; B.W.M. has acted as a paid consultant to Merck, ObsEva and Guerbet and is the recipient of grant money from an NHMRC Investigator Grant; J.E.J.S. reports lecture fees from Ferring Pharmaceuticals, Biomérieux and Besins Female Healthcare, grants from Fund for Research Flanders (FWO) and is co-inventor on granted patents on CAPA-IVM methodology in the USA (US10392601B2) and Europe (EP3234112B1); T.D.P., M.H.N.N., N.A.N., T.T.L., V.T.T.T., N.T.N., H.L.T.H. and X.T.H.L. have no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years, and no other relationships or activities that could appear to have influenced the submitted work. TRIAL REGISTRATION NUMBER NCT04296357 (www.clinicaltrials.gov). TRIAL REGISTRATION DATE 5 March 2020 DATE OF FIRST PATIENT’S ENROLMENT 7 March 2020.

IntroductionExisting randomised controlled trials (RCTs) comparing a freeze-all embryo transfer strategy and a fresh embryo transfer strategy have shown conflicting results. A freeze-all or a fresh transfer policy may be preferable for some couples undergoing in-vitro fertilisation (IVF), but it is unclear which couples would benefit most from each policy, how and under which protocols. Therefore, we plan a systematic review and individual participant data meta-analysis of RCTs comparing a freeze-all and a fresh transfer policy.Methods and analysisWe will search electronic databases (Medline, Embase, PsycINFO and CENTRAL) and trial registries (ClinicalTrials.gov and the International Clinical Trials Registry Platform) from their inception to present to identify eligible RCTs. We will also check reference lists of relevant papers. The search was performed on 23 September 2020 and will be updated. We will include RCTs comparing a freeze-all embryo transfer strategy and a fresh embryo transfer strategy in couples undergoing IVF. The primary outcome will be live birth resulting from the first embryo transfer. All outcomes listed in the core outcome set for infertility research will be reported. We will invite the lead investigators of eligible trials to join the Individual participant data meta-analysis of trials comparing frozen versus fresh embryo transfer strategy (INFORM) collaboration and share the deidentified individual participant data (IPD) of their trials. We will harmonise the IPD and perform a two-stage meta-analysis and examine treatment–covariate interactions for important baseline characteristics.Ethics and disseminationThe study ethics have been granted by the Monash University Human Research Ethics Committee (Project ID: 30391). The findings will be disseminated via presentations at international conferences and publication in peer-reviewed journals.PROSPERO registration numberCRD42021296566.

Obstetric and gynaecological conditions represent a significant burden of disease, requiring clinical research. We aimed to study trends in the publication of randomised controlled trials (RCTs) in women's health over the last two decades. The primary objective was to describe longitudinal trends in the geographical distribution of RCTs in obstetrics and gynaecology. We also described trends in trial funding, publication sources and separately published trial protocols.RCTs were identified by searching the Web of Science alone, due to the large number of results and descriptive nature of analyses. Using the filter tool, only studies labelled as "Clinical trial" or "Article" were included; all other document types were excluded. Trial protocols were identified and analysed separately. Indexing data were extracted using the Web of Science selection tools. As we aimed simply to describe research trends using a single platform, we did not check for duplicates. No process for data pooling was necessary. Correlation of GDP, funding and number of RCTs was calculated using Pearson's r test.We identified 39,071 RCTs. The number of annual publications globally increased from 1,406 in 2001 to 1,979 in 2020. The US (n = 12,479) and the UK (n = 3,745) were responsible for the most RCTs, followed by Italy (n = 2,676) and China (n = 2,338). The largest percentage increase in annual publications was seen in Iran (n = 5 to n = 113, +2,160 %) and the Western Pacific Region (n = 16 to n = 171, +968.8 %). GDP was significantly correlated with the number of published RCTs in 2019 for the 25 most prolific countries (p 0.001), but not with the proportion of RCTs funded.Despite growing contributions from the Western Pacific and Eastern Mediterranean regions, most RCTs are still produced in a small nucleus of high-income countries. Increased international collaboration may benefit both high- and low-income countries.

One unique character of reproductive medicine is the involvement of multiple individuals. Apart from individual(s) who want to become parents, also the interests offspring that is created by reproductive medicine treatments should be considered. This unique character brings unique ethical challenges, as the principle ‘Primum non nocere’ should be applied on all involved, including the children born form fertility treatments. I will present a framework that involves three dimensions, the risks for the mother, risks for the offspring and consequences for society and the public system. First, treatment can be refused as there is uncertainty about the quality of life of the future offspring. I will argue that before the treatment is started, the new individual is not there and cannot claim any rights. The care provider has a responsibility towards the future individual, not only in terms of health, but also from a social perspective. If the future child going to live an abusive family, it might be better of not existing. Second, treatment can be refused because of an unhealthy lifestyle or a health risk for the future mother. Treatment might be refused because a mother has an underlying disease that could severely exacerbate during pregnancy, or because she smokes or is obese. I will argue that in these situations decisions should be made in the context of absolute health risks for the mother and the offspring, as well as success rates of treatments. I will demonstrate that the bar to refuse treatments based on these grounds is high and that in most cases risks are acceptable while success rates are sufficiently high to justify treatment. Third, the risks of treatments should be balanced against the expected success rates of treatments. Risks of treatment are more acceptable if the success rates are higher. This obviously does not count for risks that only occur if the treatment is successful, for example pregnancy risks or risks for the offspring. Finally, treatments without proven effectiveness should preferably be offered in the context of research. Uncertainty about their effectiveness should be shared with the individual(s) who undergo the treatment. While in a private context, where patients pay their own treatment, the issue of cost-effectiveness is less relevant, efficiency is important in a public system, where society pays for treatment. In the latter case, ineffective treatments (for example IVF for older women with success rates of 1 or 2%) can be delayed in favour of less expensive treatments, or even denied. Koning A, Mol BW, Dondorp W. It is not justified to reject fertility treatment based on obesity. Hum Reprod Open. 2017 Jul 28;2017(2):hox009. Braakhekke M, Kamphuis EI, Mol F, Norman RJ, Bhattacharya S, van der Veen F, Mol BW. Hum Reprod. Effectiveness and safety as outcome measures in reproductive medicine. 2015 Oct;30(10):2249-51.

Study question Does transfer of low grade blastocysts results in acceptable live birth rates the birth of healthy babies? Summary answer While BC/CB/CC blastocysts have a reduced chance of live birth compared with AA/AB/BA/BB blastocysts, the absolute chances are still reasonable. What is known already Transfer of poorer quality embryos and blastocysts result in lower live birth rates, though to what extent is unclear, nor if there is an absolute threshold below which live births are very rare or even do not occur. Further, the developmental competence of the inner cell mass (ICM) or trophectoderm (TE) could at least theoretically impact the pregnancy and/or the health of the baby. Many clinics do not transfer or freeze poor quality embryos and blastocysts, and prefer to submit the patient to a further stimulation cycle. Study design, size, duration We performed a retrospective analysis of 10,978 couples undergoing singleton blastocyst transfers between 2009 and March 2020. We included all single blastocyst transfers for which there was complete data on blastocyst quality, singleton or twin births, birthweight and gestation at delivery, irrespective of blastocyst grading, female age, cause of infertility, ovarian response or endometrial thickness. We recorded live birth rates, birth weight and gestational age. Participants/materials, setting, methods Data from 14 clinics in 3 countries, 8 from China, 5 from New Zealand, and 1 from Australia were included in the final dataset. We compared the impact of blastocyst grading using multiple logistic regression. Blastocyst grading was based on the Gardner classification, in which the first letter denotes the grade of the inner cell mass (A is best), and the second letter the grade of the trophectoderm. Main results and the role of chance Overall, 10,978 single blastocyst cycles resulted in 4,261 live births (38.8%) (4195 singletons and 132 twins). Live birth rates were 47% after transfer of AA blastocysts (n = 2306); 42% after AB/BA (n = 2088); 33% after BC (n = 1973); 25% after CB (n = 715) and 14% after CC (n = 117). There were too few AC (n = 27) or CA (n = 12) blastocysts to include in the analysis. The odds of live birth for BC/CB/CC blastocysts compared with AA/AB/BA blastocysts, vary between 0.8 and 0.9. The live birth rate appears to be more dependent on ICM quality (C grade, n = 844, 23.2%) rather than TE quality (C grade, n = 2117, 32.1%), with the odds of live birth 0.43 and 0.57 respectively compared to A grade ICM or TE. The average birth weight (singleton only) was 3336.9+/-570.3 g (range 3323 to 3386 g), and the average gestation at delivery (singleton only) was 38+6+/-2.0 weeks (range 38+2 to 39+1). There was no significant difference for birth weight or gestational age at delivery between blastocysts of different grades. Limitations, reasons for caution This was a retrospective study. Grading was based on inner cell mass and trophectoderm and not on degree of expansion, or on day of transfer. It is likely that higher quality blastocysts were transferred first, in a fresh cycle, and poorer quality blastocysts frozen for later transfer. Wider implications of the findings The most important finding is that reasonable live birth rates are obtained in CC-blastocysts. We therefore advocate that CC-blastocysts should be replaced or frozen for later transfer. It is reassuring that there was no impact of blastocyst quality on birth weights or gestational age at the time of delivery. Trial registration number Not applicable

To explore an interaction effect between serum anti-Müllerian hormone (AMH) levels and the relative treatment effect of a freeze-all versus a fresh embryo transfer strategy on live birth.This was a retrospective cohort study investigating couples with infertility and eligible for both freeze-all and fresh embryo transfer between 2017 and 2019. Women with an absolute indication for a freeze-all strategy were excluded. Multivariable fractional polynomial interaction analysis within a logistic regression model was used to evaluate whether the treatment effect of a freeze-all versus a fresh transfer strategy varied at different AMH levels. Non-linear interactions were also considered. The primary outcome was the live birth after the first transfer.A total of 13,503 women underwent a fresh embryo transfer and 2247 women underwent a freeze-all strategy. Live birth rates were slightly higher in the freeze-all group compared to those in the fresh embryo transfer group (35% vs 33%). There was a non-linear interaction between baseline serum AMH levels and the relative treatment effect of a freeze-all strategy versus a fresh transfer strategy on live birth (P = 0.0161). The benefit on live birth from a freeze-all embryo transfer strategy was greatest in women with a high serum level ( 7 ng/ml). The interaction remained valid when different imputation methods were used.As serum AMH level increased, there was a nonlinear increase in relative treatment effect of a freeze-only transfer versus a fresh transfer strategy on live birth, and such an effect reaches its maximum in women with high AMH levels.

This study evaluated the effectiveness of Paraffin oil versus Mineral oil for day-5 embryo culture in couples undergoing assisted reproductive technology (ART).We performed a multi-centre, retrospective cohort study at IVFMD (My Duc Hospital) and IVFMD Phu Nhuan (My Duc Phu Nhuan Hospital) from January 2019 to September 2019. We studied couples treated by intracytoplasmic sperm injection (ICSI), using fresh, ejaculated semen and undergoing day-5 embryo transfer. Couples who underwent in vitro maturation (IVM) or oocyte donation cycles or couples where the woman had uterine abnormalities were excluded. From January 2019 to May 2019, we used Mineral oil (LiteOil, LifeGlobal) while Paraffin oil (Liquid Paraffin, Origio) was used from June 2019 to September 2019. The primary outcome was live birth rate after the first transfer, either from a fresh transfer or frozen embryo transfer.Between 1st January 2019 to 30th September 2019, there were 2,312 couples undergoing ART in both centres, of which 762 (377 in the Paraffin group and 385 in the Mineral group) eligible couples were included in the study. Baseline characteristics of couples were comparable between the two groups, with mean female age 31.5 ± 4.3 versus 31.9 ± 4.7 in the Paraffin and Mineral group. Live birth after the first transfer occurred in 153 (40.6%) couples in the Paraffin group, compared to 152 (39.5%) couples in the Mineral group (risk ratio 1.02, 95% confidence interval 0.91 - 1.14). Other secondary outcomes were comparable between the two groups.In day-5 embryo culture, Paraffin and Mineral oil resulted in a comparable live birth rate.

The science community generally believes that the violation of research integrity is rare. Built upon this belief, the scientific system makes little effort to examine the trustworthiness of research. Research misconduct refers to an intentional violation of research integrity principles, which has an extensive and far-reaching impact on the trustworthiness and reputation of science. Emerging evidence has suggested that research misconduct is far more common than we normally perceive. Far more problematic papers should be retracted than are being retracted because of poor actions when confronting research misconduct. Research misconduct is usually driven by incentives in the form of pursuing publications for researchers' career needs and is further facilitated by poor research governance. The current strategy that tackles potential research misconduct focuses on protecting the reputation of authors and their institutions but neglects the interests of patients, clinicians and honest researchers. Removing improper incentives, training researchers and imposing better governance are vital to reducing research misconduct. Awareness of the possibility of misconduct and formalized procedures that scrutinize study trustworthiness are important during peer review and in systematic reviews.

What is the impact of the response to COVID-19 on the management of fertility treatments and clinical practice around the world?Fertility clinic associates around the world were approached. They completed an online survey containing 33 questions focused on the country's response to the COVID-19 pandemic. Known fertility clinic associates that were contacted comprised scientific directors, medical directors and laboratory managers.There were 43 individual country responses from Asia (13), Africa (3), Europe (17), North America (3), Oceania (2) and South America (5). In nine countries, clinics followed their government body recommendations, in 22 countries there was a combination of recommendations, in 3 countries changes were made by clinic initiative, and 9 countries did not specify. In 34 countries IVF/intracytoplasmic sperm injection (ICSI) and frozen embryo transfer (FET) treatments had an average delay of 56 days (IVF/ICSI) (minimum 0, maximum 160) and 57 days (FET) (minimum 0, maximum 166 days). During the shutdown, the number of freeze-all cycles increased in 22 countries. Only 23 countries reported patients having to undergo a SARS-CoV-2 test, and 20 countries did not report any COVID-19 testing in their clinic. Additional support counselling was offered in 28 countries, partner restrictions at clinics were reported in 41 countries and time between patients' appointments was increased in 39 countries.The implications of COVID-19 mitigation measures proved the need for government societies to introduce a set protocol that includes requirements such as increased patient counselling and additional guidelines for prioritizing couples who need care most urgently.

IntroductionDietary and/or physical activity interventions are often recommended for women with overweight or obesity as the first step prior to fertility treatment. However, randomised controlled trials (RCTs) so far have shown inconsistent results. Therefore, we propose this individual participant data meta-analysis (IPDMA) to evaluate the effectiveness and safety of dietary and/or physical activity interventions in women with infertility and overweight or obesity on reproductive, maternal and perinatal outcomes and to explore if there are subgroup(s) of women who benefit from each specific intervention or their combination (treatment–covariate interactions).Methods and analysisWe will include RCTs with dietary and/or physical activity interventions as core interventions prior to fertility treatment in women with infertility and overweight or obesity. The primary outcome will be live birth. We will search MEDLINE, Embase, Cochrane Central Register of Controlled Trials and trial registries to identify eligible studies. We will approach authors of eligible trials to contribute individual participant data (IPD). We will perform risk of bias assessments according to the Risk of Bias 2 tool and a random-effects IPDMA. We will then explore treatment–covariate interactions for important participant-level characteristics.Ethics and disseminationFormal ethical approval for the project (Venus-IPD) was exempted by the medical ethics committee of the University Medical Center Groningen (METc code: 2021/563, date: 17 November 2021). Data transfer agreement will be obtained from each participating institute/hospital. Outcomes will be disseminated internationally through the collaborative group, conference presentations and peer-reviewed publication.PROSPERO registration numberCRD42021266201.

This journal suppl. entitled: Abstracts of the 26th Annual Meeting of the European Society of Human Reproduction and Embryology, Rome, Italy, 27-30 June 2010

BACKGROUND: Based on a presumed negative impact of overweight and obesity on reproductive capacity and pregnancy outcome, some national guidelines and clinicians have argued that there should be an upper limit for a woman's BMI to access assisted reproductive technologies (ART). However, evidence on the risk of complications or expected success rate of ART in obese women is scarce. We therefore performed a systematic review on the subject.METHODS: We searched the literature for studies reporting on complications or success rates in overweight and obese women undergoing ART. Articles were scored on methodological quality. We calculated pooled odds ratios (ORs) to express the association between overweight and obesity on the one hand, and complications and success rates of ART on the other hand. We only pooled results if data were available per woman instead of per cycle or embryo transfer.RESULTS: We detected 14 studies that reported on the association between overweight and complications during or after ART, of which 6 reported on ovarian hyperstimulation syndrome (OHSS), 7 on multiple pregnancies and 6 on ectopic pregnancies. None of the individual studies found a positive association between overweight and ART complications. The pooled ORs for overweight versus normal weight for OHSS, multiple pregnancy and ectopic pregnancy were 1.0 [95% confidence interval (CI) 0.77-1.3], 0.97 (95% CI 0.91-1.04) and 0.96 (95% CI 0.54-1.7), respectively. In 27 studies that reported on BMI and the success of ART, the pooled ORs for overweight versus normal weight on live birth, ongoing and clinical pregnancy following ART were OR 0.90 (95% CI 0.82-1.0), 1.01 (95% CI 0.75-1.4) and OR 0.94 (95% CI 0.69-1.3), respectively.CONCLUSIONS: Data on complications following ART are scarce and therefore a registration system should be implemented in order to gain more insight into this subject. In the available literature, there is no evidence of overweight or obesity increasing the risk of complications following ART. Furthermore, they only marginally reduce the success rates. Based on the currently available data, overweight and obesity in itself should not be a reason to withhold ART.