Effect of low-dose aspirin on the development of ovarian hyperstimulation syndrome and outcomes of assisted reproductive techniques in the women with PCOS, a randomized double-blinded clinical trial.

OBJECTIVE: Ovarian hyperstimulation syndrome (OHSS) is a major complication of assisted reproductive technologies (ART). Polycystic ovary syndrome (PCOS) is a risk factor for OHSS. The aim of this randomized clinical trial (RCT) was to study the effect of low-dose aspirin (LDA) on the development of OHSS and ART outcomes in PCOS during ART. MATERIALS AND METHODS: This double-blinded placebo controlled RCT was performed on 232 PCOS infertile women in their first ART cycles during 2010-2016. LDA and placebo capsules were prepared, packed and specified by code numbers in similar shapes. One package was given to every woman and asked to take one capsule/day since the 21st day of her cycle prior to the gonadotropin stimulation. Gonadotropin releasing hormone agonist long protocol and triggering by human chorionic gonadotropin were used. Development of moderate to severe OHSS and their ART outcomes were documented then the codes were broken and data analyzed. Chi-square and Mann-Whitney U tests were used for the statistical analyses. RESULTS: Eighteen cases that did not follow the study design were excluded. 214 cycles remained for the final analyses with 109 cases in LDA and 105 in the placebo group. Rate of the moderate to severe OHSS in LDA group was 34.9% compared to 30.5% in placebo group (P = 0.494). Fertilization rate was 71.8% vs 65.1% (P = <0.001) and the mean number of grade III embryos were 3.28 ± 3.53 vs 1.46 ± 1.42 (P = 0.014) in LDA and placebo groups, respectively. The mean number of the oocytes in different grades, total and frozen embryos also implantation and clinical pregnancy rates were not different between the groups. CONCLUSION: Moderate to Severe OHSS was not decreased but fertilization rate and the mean number of poor quality embryos were increased in LDA arm. REGISTRATION NUMBER: IRCT 201105216541N1.

A randomized, controlled clinical trial comparing the effects of aromatase inhibitor (letrozole) and gonadotropin-releasing hormone agonist (triptorelin) on uterine leiomyoma volume and hormonal status.

OBJECTIVE: To examine and compare the efficacy and safety of GnRH agonist (GnRHa) vs. aromatase inhibitor in premenopausal women with leiomyomas. DESIGN: Multicenter, randomized, controlled clinical trial. SETTING: University hospitals. PATIENT(S): A total of 70 subjects with a single uterine myoma measuring >or=5 cm. Subjects were randomized into two groups with use of a random table. They were treated with aromatase inhibitor (group A) or GnRHa (group B). INTERVENTION(S): Group A received letrozole (2.5 mg/d) for 12 weeks. Group B received triptorelin (3.75 mg/mo) for 12 weeks. MAIN OUTCOME MEASURE(S): Measurement of myoma volume and E(2), FSH, LH, and T levels. RESULT(S): Total myoma volume decreased by 45.6% in group A and 33.2% in group B. Reductions in myoma volume in the two groups were statistically significant. There was no significant change in hormonal milieu in group A. The serum level of hormones significantly decreased in group B by the 12th week of treatment. CONCLUSION(S): Uterine myoma volume was successfully reduced by use of an aromatase inhibitor. Rapid onset of action and avoidance of initial gonadotropin flare with an aromatase inhibitor may be advantageous for short-term management of women with myomas of any size who are to be managed transiently and who wish to avoid surgical intervention, specifically women with unexplained infertility having uterine myoma.