Study of REKOVELLE Use in Chinese Women Undergoing IVF or ICSI to Assess Effectiveness, Safety, and Treatment Patterns in Real-World Settings

What this Trial Is About

This research aims to observe the use of REKOVELLE4 in Chinese women undergoing assisted reproductive technologies such as in vitro fertilisation IVF or intracytoplasmic sperm injection ICSI. The study will gather information on how REKOVELLE4 is used in routine clinical practice, focusing on its effectiveness, safety, and usage patterns. About 2500 women will be enrolled across 30 to 50 sites in China. The total study duration will be approximately 35 months. This is a non-interventional, observational study where participants will receive REKOVELLE4 as prescribed by their doctors during controlled ovarian stimulation for IVF or ICSI cycles. The study does not assign treatments but monitors the natural use of REKOVELLE4 in a real-world setting. No additional treatments or interventions are planned by the study itself. Participants will be followed for up to 15 months to measure outcomes like live birth rates per initiated stimulation cycle. Additional data collected include hormone levels, cycle cancellations, number of oocytes and embryos, implantation rates, pregnancy rates at various stages, and safety information such as adverse reactions and ovarian hyperstimulation syndrome occurrences. Researchers will also track medication doses and stimulation durations. This comprehensive monitoring helps understand REKOVELLE4 use and associated outcomes in everyday clinical practice.

To Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patterns of Use in Real-world Practice