Liraglutide Protocol Aims to Boost Live Birth Rates in Obese, Infertile PCOS Women

Polycystic ovary syndrome (PCOS) is a prevalent endocrine disorder and the primary cause of anovulatory infertility in women, frequently co-occurring with obesity. Obese PCOS patients face increased challenges in achieving successful pregnancies, even with assisted reproductive technologies like in vitro fertilization-frozen embryo transfer (IVF-FET). Liraglutide, a GLP-1 analog, is approved for obesity and is known to improve insulin resistance and stabilize blood glucose metabolism without increasing hypoglycemia risk. Prior studies suggest liraglutide can also positively influence sex hormone profiles and menstrual cycles in obese PCOS women, hinting at potential fertility benefits. This trial protocol addresses the critical need for interventions that can enhance live birth rates in this specific high-risk population.

This project outlines the protocol for a large-sample randomized controlled trial (RCT) designed to assess the efficacy of liraglutide in obese, infertile PCOS women. The study will enroll 150 participants who are undergoing in vitro fertilization-frozen embryo transfer (IVF-FET). The intervention involves administering liraglutide to a treatment arm before the embryo transplantation. The primary endpoint is to determine if this pre-treatment can significantly improve the live birth rate of assisted reproduction. The trial is registered as NCT05965908 and is a Phase 3 study.

As this is a study protocol, no actual findings or results are reported from the trial itself. The abstract describes the hypothesis that liraglutide pre-treatment will reduce weight and improve metabolic parameters, thereby enhancing the live birth rate in obese, infertile PCOS women undergoing IVF-FET. The study aims to test if liraglutide can improve glucose metabolism, body weight, and inflammation levels, as well as sex hormone profiles and menstrual cycles, ultimately contributing to increased fertility. Specific numerical outcomes, statistical significance, or effect sizes are not yet available.