Abstract

Background: We developed a multicenter randomized observational trial to assess the effectiveness of letrozole monotherapy and the co-therapy of letrozole and gonadotropins on pregnancy outcomes including the ovulation induction, pregnancy rate, estradiol (E2) levels and endometrial thickness in infertile women with polycystic ovarian syndrome (PCOS).Methods:At three in vitro fertilization (IVF) centers in Egypt, we conducted our study since May 2019 until we have recruited the planned number of patients. Infertile PCOS patients were recruited after they met our criteria. We had two intervention groups based on the treatment regimen.Moreover, baseline parameters, outcomes, and hormonal assessment was conducted throughout the study period. Results: We included 90 patients in this study and were equally randomized into two groups; the letrozole monotherapy (Group A) and the letrozole with gonadotropins (Group B) groups. The mean age was significantly higher in group A [26 (±3.5)] than group B [24.2 (±3.1)] (P= 0.015). Both groups showed resulted in similar pregnancy rates (31.1%) (P= 0.079).Moreover, group B [2.4 (±0.8)] resulted in a significantly higher (P= 0.023) mean number of follicles than group A [2.0 (±0.7)]. On the other hand, no statistical significance was estimated in terms of estradiol levels and endometrial thickness (P= 0.209 and 0.485, respectively).

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