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BACKGROUND: Preterm birth is a global health priority. Using a progestogen during high-risk pregnancy could reduce preterm birth and adverse neonatal outcomes.METHODS: We did a systematic review of randomised trials comparing vaginal progesterone, intramuscular 17-hydroxyprogesterone caproate (17-OHPC), or oral progesterone with control, or with each other, in asymptomatic women at risk of preterm birth. We identified published and unpublished trials that completed primary data collection before July 30, 2016, (12 months before data collection began), by searching MEDLINE, Embase, CINAHL, the Maternity and Infant Care Database, and relevant trial registers between inception and July 30, 2019. Trials of progestogen to prevent early miscarriage or immediately-threatened preterm birth were excluded. Individual participant data were requested from investigators of eligible trials. Outcomes included preterm birth, early preterm birth, and mid-trimester birth. Adverse neonatal sequelae associated with early births were assessed using a composite of serious neonatal complications, and individually. Adverse maternal outcomes were investigated as a composite and individually. Individual participant data were checked and risk of bias assessed independently by two researchers. Primary meta-analyses used one-stage generalised linear mixed models that incorporated random effects to allow for heterogeneity across trials. This meta-analysis is registered with PROSPERO, CRD42017068299.FINDINGS: Initial searches identified 47 eligible trials. Individual participant data were available for 30 of these trials. An additional trial was later included in a targeted update. Data were therefore available from a total of 31 trials (11 644 women and 16185 offspring). Trials in singleton pregnancies included mostly women with previous spontaneous preterm birth or short cervix. Preterm birth before 34 weeks was reduced in such women who received vaginal progesterone (nine trials, 3769 women; relative risk [RR] 0·78, 95% CI 0·68-0·90), 17-OHPC (five trials, 3053 women; 0·83, 0·68-1·01), and oral progesterone (two trials, 181 women; 0·60, 0·40-0·90). Results for other birth and neonatal outcomes were consistently favourable, but less certain. A possible increase in maternal complications was suggested, but this was uncertain. We identified no consistent evidence of treatment interaction with any participant characteristics examined, although analyses within subpopulations questioned efficacy in women who did not have a short cervix. Trials in multifetal pregnancies mostly included women without additional risk factors. For twins, vaginal progesterone did not reduce preterm birth before 34 weeks (eight trials, 2046 women: RR 1·01, 95% CI 0·84-1·20) nor did 17-OHPC for twins or triplets (eight trials, 2253 women: 1·04, 0·92-1·18). Preterm premature rupture of membranes was increased with 17-OHPC exposure in multifetal gestations (rupture INTERPRETATION: Vaginal progesterone and 17-OHPC both reduced birth before 34 weeks' gestation in high-risk singleton pregnancies. Given increased underlying risk, absolute risk reduction is greater for women with a short cervix, hence treatment might be most useful for these women. Evidence for oral progesterone is insufficient to support its use. Shared decision making with woman with high-risk singleton pregnancies should discuss an individual's risk, potential benefits, harms and practicalities of intervention. Treatment of unselected multifetal pregnancies with a progestogen is not supported by the evidence.FUNDING: Patient-Centered Outcomes Research Institute.

Background: Infertility is a problem affecting a large number of couples in the world. One of the causes of infertility can be chromosomal rearrangements such as insertions. In this case report study, the outcome of two intra-cytoplasmic sperm injection (ICSI) cycles of an infertile woman with de novo chromosomal insertion is explained. Case Presentation: A couple with a 10-year history of infertility referred to our infertility clinic. The husband had a daughter in his first previous marriage. The wife had a 7 and a 10 year history of infertility in the first and second marriages, respectively. In the first marriage, she reported a history of 2 failed intra-uterine insemination (IUI) cycles. In the second marriage, she had a history of 1 spontaneous abortion at 12 weeks of pregnancy, 4 failed IUI cycles, and 1 failed ICSI cycle. The couple was subjected to ICSI cycles twice and failed due to embryo development arrest. The couple referred for karyotyping. The husband showed a normal male karyotype. In comparison, the wife revealed an abnormal female karyotype with two rearrangements: chromosome 13 with an interstitial deletion between bands q14.2 and q21.1, and a derivative chromosome 7 containing this segment of chromosome 7 as an insertion onto short arm at the p14 position. Conclusion: To the best of our knowledge, this is the first report of insertion 46 XX, ins(7:13)(p14; q14.2q21.1) which is associated with the embryo development arrest following assisted reproductive technique.

Background: Different progesterone doses and routes are used for luteal phase support in stimulated intrauterine insemination (IUI) cycles, but the optimal supplementation scheme has not yet been determined. Therefore, our aim was to compare the administration of two different doses of vaginal progesterone with two doses of intramuscular (IM) progesterone for luteal phase support in patients undergoing IUI cycles. Methods: In this randomized clinical trial, 312 women with unexplained or male-factor infertility intending to start IUI cycles between April 2015 and January 2018 were included. They were randomized into four groups (n=78/each) including group 1 who received IM progesterone in oil (25 mg daily), group 2 who received IM progesterone in oil (50 mg daily), group 3 who received progesterone suppository (400 mg daily), and group 4 who received progesterone suppository (800 mg daily; 400 mg twice daily). The primary outcome was the clinical pregnancy rate. The ongoing pregnancy rate, abortion rate, and patients’ satisfaction, and convenience the secondary outcomes. Results: In our study, the overall clinical and ongoing pregnancy rates per cycle with COS and IUI were 16.02% and 12.8%, respectively. There were no significant differences in clinical pregnancy, ongoing pregnancy, and abortion rates among groups (p=0.84). The overall patients’ satisfaction and convenience was significantly higher in the vaginal progesterone suppository groups than the IM progesterone groups (p=0.001). Conclusion: The results of this study showed that vaginal progesterone administration provides a more easy-to-use and convenient method than IM progesterone administration for luteal phase support in IUI cycles with comparable pregnancy rates.

Background: Different protocols are used for controlled ovarian hyper stimulation (COH), but the optimal method has not yet been determined. Objective: The aim of this study was to compare the outcome of controlled ovarian stimulation (COS) using clomiphen citrate (CC) plus HMG versus CC plus rFSH in intra uterine insemination cycles (IUI). Materials and Methods: 144 women with unexplained or male factor infertility undergoing IUI cycles were randomized (72 patients in CC plus rFSH group and 72 patients in CC plus HMG group) and included in this single blind study from October 2006 to June 2010. The primary outcomes were clinical and ongoing pregnancy rates. The number of dominant follicles, mean of follicular size, endometrial thickness on the day of HCG administration, total dose of gonadotropins and duration of stimulation with gonadotropins were secondary outcomes. Results: Clinical and ongoing pregnancy rates were not significantly different in the two groups .There was a significant higher multiple pregnancy rate in CC plus rFSH group (33.3%) versus CC plus HMG group (12.5%; p

Introduction: Polycystic ovary syndrome (PCOS) is one of the most common causes of anovulatory infertility. Clomiphen citrate (CC) is the first line therapy for women with infertility and PCOS. These patients usually respond to clomiphene citrate in doses between 50-100 mg/day. However, fialure of the patient to respond to a dosage of 150 mg/day of clomiphene citrate is considered as clomiphene resistant. The aim of this study was to compare between pregnant and non-pregnant women in cases of PCOS patients with CC resistant. Meanwhile, we evaluated ovulatory rate, pregnancy rate and live birth rates. Materials and Methods: We studied 106 CC-resistant PCOS patients who attended to Amir-Al- Momenin Hospital (Semnan, Iran) during the years 2005-2008. After an initial 6-8 weeks of metformin (1500mg daily: 500mg q8h), they received 2.5mg letrozole for 5 days starting on cycle day 3. If they failed to show ovluation with 2.5mg letrozole, doses were increased to 5 and 7.5 mg daily in the subsequent cycles. Results: One patient developed generalized rash with metformin and excluded from the study. 14 of 105 patients (13.33%) conceived with metformin alone. Overall, ovulation rate was 83.91(91.2%). Overall, pregnancy rate was 60/105 (57.14%) with 45 (74.9%) full term pregnancies, 10 (16.7%) abortions and 5 (8.3%) preterm births. The only significant difference between the responder and non-responder was found in the age of patients (P=0.008) . No significant differences were found in BMI, period of infertility, menstrual pattern, hirsutism, pictures of PCO in one or two ovaries in sonography, LH, and FSH or LH/FSH ratio. Conclusion: Combination of metformin with incremental doses of letrozole associated with a good pregnancy rate in CC-resistant PCOS patients. The treatment seems especially more effective in young weman.

Objective: The aim of this study is to determine if simvastatin pretreatment would change clomiphene response in clomiphene citrate-resistant (CC-R)women with (PCOS). Materials and methods: This quasi experimental study included twenty five clomiphene resistant women with PCOS. All patients received cyclic oral contraceptives pills (OCP) (30µg of ethinyl estradiol and 150µg of desogestrol) from the 5th day of their spontaneous or progesterone (P) induced menstrual cycle; in addition, they received simvastatin (20mg/day) from the first day of cycle for two consecutive months. Then, patients were given 100 mg clomiphene citrate (CC) (Iran Hormone, Iran) for five days starting from day three of their menstrual cycles. The primary outcome measures were ovulation and pregnancy rates. The change in body mass index (BMI), the mean number of follicles ≥ 18 mm, the mean of follicular size and endometrial thickness on the day of human chorionic gonadotropin (HCG) administration were secondary outcome measures. Results: Ovulation occurred in 5 out of 25 (20%) patients, but none of the patients conceived in this study. No important change in BMI was observed after using simvastatin (0.28 + 1.13; p = 0.228). In all patients with ovulation, the number of follicles ≥ 18mm was one. The mean follicular size and endometrial thickness on the day of HCG administration were 19.67 ± 2.04 and 7.00 ± 1.34, respectively. Conclusion: In this study, we did not observe the favorable effect on ovulation and pregnancy rates with CC following of simvastatin pretreatment in CC-resistant PCOS women. So, further studies with a larger number of patients, higher doses of CC and more cycles are necessary to make this obvious.

Background: Different protocols are used for controlled ovarian hyper stimulation (COH), but the optimal method has not yet been determined. Objective: The aim of this study was to compare the outcome of controlled ovarian stimulation (COS) using clomiphen citrate (CC) plus HMG versus CC plus rFSH in intra uterine insemination cycles (IUI). Materials and Methods: 144 women with unexplained or male factor infertility undergoing IUI cycles were randomized (72 patients in CC plus rFSH group and 72 patients in CC plus HMG group) and included in this single blind study from October 2006 to June 2010. The primary outcomes were clinical and ongoing pregnancy rates. The number of dominant follicles, mean of follicular size, endometrial thickness on the day of HCG administration, total dose of gonadotropins and duration of stimulation with gonadotropins were secondary outcomes. Results: Clinical and ongoing pregnancy rates were not significantly different in the two groups .There was a significant higher multiple pregnancy rate in CC plus rFSH group (33.3%) versus CC plus HMG group (12.5%; p

Objective To compare the efficacy, tolerability, and convenience of two formulations of the follitropin-α (Gonal-f) pen device versus the conventional form in Iranian women undergoing ovarian stimulation for intracytoplasmic sperm injection. Design Randomized, single-center trial, parallel-group, single blind. Setting Tertiary referral center, University Hospital. Patient(s) A total of 100 patients undergoing intracytoplasmic sperm injection. Intervention(s) After down-regulation with busereline acetate, patients were randomized to receive the pen device or the conventional syringe of follitropin-α. A computer-generated randomization list was used to allocate the patients to one of these two groups. Main Outcome Measure(s) The primary outcomes were patients' satisfaction, convenience, occurrence of local tolerance symptoms, and pain. Total dose of follitropin-α, duration of follitropin-α treatment, number of oocyte retrieved, number of viable embryos, and clinical pregnancies were secondary outcome measures. Data collection was performed by means of a questionnaire designed for the purpose of this study. The pain scored according to the Visual Analogue Scale. Result(s) Self-administration and patients' satisfaction were significantly higher in the pen device group than the conventional syringe group. Local reactions at injection sites and pain were significantly higher in the conventional syringe group than in the pen device group. There were no statistically differences in secondary outcome measures and convenience between two groups. Conclusion(s) Among the Iranian patients that we studied, the pen device of Gonal-f is safe, convenient, and less painful, with more patients' satisfaction than the conventional syringe form, but both forms have equal efficacy in intracytoplasmic sperm injection cycles.

Bacterial vaginosis and Trichomons vaginalis are believed to be the risk factors for preterm labor birth and preterm prelabor rupture of membranes. The objective of this study was to investigate the association between bacterial vaginosis, T.vaginalis, and vaginal pH with preterm labor birth and preterm prelabor rupture of membranes after excluding other known risk factors.In this cohort study, we enrolled 1223 pregnant women with gestational age of 16 - 36 weeks from Amir-Almomenin General Hospital in Semnan, Iran, who had no known medical risk factors for preterm labor birth. Bacterial vaginosis and T.vaginalis were determined on the basis of vaginal pH, saline wet mount, and Amsel tests. The principal outcome was delivery before 37 weeks of gestation and preterm prelabor rupture of membranes.Bacterial vaginosis and T.vaginalis were detected in 16.0% and 5.5% of these women, respectively. Bacterial vaginosis was positive in 65 (33.1%) patients at 16 - 20 weeks of gestation and in 134 (66.9%) patients at 36 weeks of gestation or during labor (developing preterm labor birth or preterm prelabor rupture of membranes). The frequencies for T.vaginalis were 20 (29.9%) and 47 (70.1%) patients, respectively. All patients with bacterial vaginosis and T.vaginalis had a vaginal pHor = 5. There was a significant correlation between bacterial vaginosis and vaginal pHor = 5, with preterm labor birth (OR: 5.99; CI: 3.79 - 9.49) and preterm prelabor rupture of membranes (OR: 2.34; CI: 1.07 - 4.99). Moreover, a significant correlation was found between vaginal pHor = 5 with preterm labor birth (OR: 5.82; CI: 2.96 - 11.39) and preterm prelabor rupture of membranes (OR: 4.11; CI: 1.62 - 10.12). There was no significant correlation between T.vaginalis with preterm labor birth (OR: 0.73; CI: 0.22 - 2.17) and preterm prelabor rupture of membranes (OR: 1.22; CI: 0.29 - 5.05).The presence of bacterial vaginosis or vaginal pHor = 5 at 16 - 36 weeks of gestation is associated with an increased risk of preterm labor birth and preterm prelabor rupture of membranes.

Background: Preterm birth is the major cause of neonatal mortality and morbidity. Objective: The aim of this study was to evaluate the effect of prophylactic vaginal progesterone on decreasing preterm birth rate and neonatal complications in a high-risk population. Materials and Methods: A randomized, double-blind, placebo-controlled study was performed on 100 high-risk singleton pregnancies. Vaginal suppository progesterone (400 mg) or placebo was administered daily between 16-22 wks to 36 wks of gestation. Progesterone (n=50) and placebo (n=50) groups were compared for incidence of preterm delivery and neonatal complications. Results: The preterm birth rate was 52%. Preterm birth rate before the 37 wks of gestation (68% vs. 36%: RR=1.89, 95% CI: 1.25-2.86) and also before the 34 wks of gestation (42% vs. 18%: RR=2.33, 95% CI: 1.19-4.58) in placebo group was significantly higher than progesterone group. Our study also showed that the administration of vaginal progesterone was associated with a significant reduction in the risk of birth weight ≤2500 gr, the rates of respiratory distress syndrome (RDS) and admission to the Neonatal Intensive Care Unit (NICU) in the progesterone group when compared with the placebo group. However, there was no significant difference between the two groups in terms of neonatal death, days of admission in NICU, intraventricular hemorrhage and necrotizing enterocolitis. Conclusion: Prophylactic vaginal progesterone reduced the rate of preterm delivery, the risk of a birth weight ≤2500 gr, the rates of RDS and admission to NICU in women who were at risk of preterm delivery.