Comparison Between Letrozole With and Without Gonadotropins Injection on Pregnancy Rates in Infertile PCOS Patients : A Multicenter Randomized Observational Trial

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). Materials and 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 were 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). Conclusion: We concluded that letrozole monotherapy and in combination with gonadotropins obtain better pregnancy rates in PCOS patients. Moreover, the combination may be useful in reducing gonadotropin adverse events with the same acceptable rates.