Abstract

PurposeTo compare ovulation rates between Letrozole and Clomiphene Citrate (CC) using a stair-step protocol to achieve ovulation induction in women with Polycystic Ovarian Syndrome (PCOS).MethodsThis is a retrospective cohort of predominantly Hispanic PCOS women of reproductive age who completed ovulation induction (OI) comparing women who underwent Letrozole stair-step protocol to those who underwent OI with CC stair-step. All women had a diagnosis of PCOS based on the 2003 Rotterdam criteria. For both protocols, sequentially higher doses of Letrozole or CC were given 7 days after the last dose if no dominant follicles were seen on ultrasonography. The primary outcome was ovulation rate (determined by presence of a dominant follicle) between the two treatment groups. Secondary outcomes included time to ovulation, clinical pregnancy rates and side effects.Results49 PCOS patients completed a Letrozole stair-step cycle and 43 completed a CC stair-step cycle for OI. Overall, demographics were comparable between both groups. Ovulation rates with the Letrozole stair-step protocol were equivalent to CC stair-step protocol (96% vs 88%, p = 0.17). Although the mean time (days) to ovulation was shorter in the Letrozole group (19.5 vs 23.1, p = 0.027), the pregnancy rates were similar for both groups.ConclusionsThis is the first study to date that has compared the efficacy of the stair-step protocol in PCOS patients using Letrozole and CC. Both Letrozole and CC can be prescribed in a stair-step fashion. Letrozole stair-step was as efficacious as CC stair-step; patients achieved comparable rates of ovulation and clinical pregnancy. Time to ovulation was shorter in the Letrozole protocol.

Highlights

  • Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in reproductive-aged women and the number one cause of infertility due to oligo-anovulation [1, 2]

  • The majority of women were Hispanic in both groups, there was a larger proportion of Hispanic women in the Letrozole group than Clomiphene Citrate (CC) (98% vs 72%, p < 0.001)

  • The results of our study indicate that the Letrozole stairstep protocol yielded higher ovulation rates than the CC protocol for Polycystic Ovarian Syndrome (PCOS) patients, the results did not reach statistical significance (p = 0.17)

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Summary

Introduction

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in reproductive-aged women and the number one cause of infertility due to oligo-anovulation [1, 2]. 4 to 8% of reproductive age women have this metabolic disorder [3]. The first line fertility treatment for anovulatory women has been clomiphene citrate (CC) for ovulation induction for the past few decades. In the RCT, the ovulation rate for CC and Letrozole was 48.3% vs 61.7% with a live birth rate of 19.1% vs 27.5% respectively [4] These studies have altered standard of practice, and the first line treatment for anovulation in women with PCOS should include Letrozole

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