Effect of Letrozole, Berberine, or Their Combination for Infertility in Women with Polycystic Ovary Syndrome: Statistical Analysis Plan for a Multicenter Randomized Controlled Trial

Abstract

Introduction: Letrozole showed higher ovulation and live birth rates than clomiphene in infertile women with polycystic ovary syndrome (PCOS). Berberine, a major active component of Chinese herbal medicine rhizomacoptidis, has been used to improve insulin resistance to facilitate ovulation induction in women with PCOS, but there is no study reporting the live birth or its potential as a complementary treatment to letrozole. We aim to determine the efficacy of letrozole with or without berberine in achieving live births among 644 infertile women with PCOS in Mainland China.

Keywords

• Polycystic ovary syndrome
• Statistical analysis plan
• Randomized controlled trial
• Letrozole
• Berberine