A Randomized Cohort Study: Is It Worth the Time to Receive Antiandrogenic Pretreatment Before Ovulation Induction for Women With Polycystic Ovary Syndrome?

Zhiyan Chen,Qi Yu,Jichun Tan,Jian Liu,Beihong Zheng,Zhengyi Sun,Guimin Hao,Zaixin Guo,Huichun Wang

doi:10.3389/fendo.2022.813188

Abstract

ObjectiveTo assess the effect of antiandrogenic pretreatment using combined oral contraceptives (COCs) before ovulation induction in infertile patients with polycystic ovary syndrome (PCOS) with hyperandrogenism.DesignProspective, randomized open-labeled cohort studySettingMulticenterPatientsPCOS patients with hyperandrogenism and requiring infertility treatmentsInterventionsRandomization to direct ovulation induction of letrozole (letrozole group) or ethinylestradiol/cyproterone acetate (EE/CPA) for 3 months and subsequent letrozole-induced ovulation (EE/CPA+ letrozole group). The maximum number of ovulation induction cycle was three to four.Main Outcome MeasuresOvulation rate, conception rate, ongoing pregnancy rate, and live birth rate were the main outcomes of the study.ResultsThere were no significant differences in the cumulative ovulation, conception, ongoing pregnancy, and live birth rates between the letrozole and EE/CPA+ letrozole groups (cumulative ovulation: 206/254 [81.10%] vs. 169/205 [82.44%], risk ratio [RR]= 1.09 [0.68,1.76], P=0.713; conception: 44/90 [48.89%] vs. 42/76 [55.26%], RR= 1.29 [0.70,2.38], P=0.413; ongoing pregnancy: 33/90 [36.67%] vs. 33/76 [43.42%], RR=1.33 [0.71,2.47], P=0.376; and live birth: 32/90 [35.56%] vs. 31/76 [40.79%], RR=1.25 [0.67, 2.34], P=0.489).ConclusionsThe results of this study showed that COC pretreatment was not superior to direct letrozole-induced ovulation therapy in improving ovulation and pregnancy results in women with PCOS. There is no benefit to perform antiandrogenic therapy before ovulation induction in patients with PCOS in clinical practice.Clinical Trial Registration www.clinicaltrials.gov, identifier ChiCTR1900022839

Highlights

Polycystic ovary syndrome (PCOS) is the most prevalent endocrine disorder affecting approximately 6–15% of women of reproductive age [1]
This was a multicentered prospective randomized controlled trial (RCT) study, conducted in six centers from the south, west, north, and central regions of China according to the Consolidated Standards of Reporting Trials (CONSORT) [12]
This study was registered in the Chinese Registry of Clinical Trials at www.clinicaltrials.gov and was approved by the Institutional Review Board (IRB) of Peking Union Medical College Hospital (No: JS-1796)

Summary

Introduction

Polycystic ovary syndrome (PCOS) is the most prevalent endocrine disorder affecting approximately 6–15% of women of reproductive age [1]. Reproduction problems, including anovulatory infertility and increased adverse pregnancy events, affect 40% of patients with PCOS [2]. One of the priorities in the treatment of PCOS is to improve the fertility of patients, and tremendous endeavor has been made by clinicians in this regard. Hyperandrogenism is a prominent clinical hallmark of PCOS, which plays a detrimental role in female fecundity and may be a treatment target for conquering the reproduction problems [1]. Previous studies have revealed that hyperandrogenism is associated with an increased risk of preterm delivery and preeclampsia in patients with PCOS [5]. Antiandrogenic therapy may help enhance pregnancy outcomes in patients with PCOS with androgen excess in the long run

Methods

Results

Discussion

Conclusion