Prospective, Post-authorisation, Multi-centre, Non-interventional Study to Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patterns of Use in Real-world Practice

简要总结

主要结局

次要结局

• Serum oestradiol levels(Up to 20 days)
• Progesterone (P4) levels(Up to 20 days)
• Cycle cancellation rate and reasons for cycle cancellation(Up to 28 days)
• Number of oocytes retrieved(Up to 22 days)
• Number of metaphase II (MII) oocytes(Up to 22 days)
• Number of embryos on Day 3 after oocyte retrieval(Day 3 after oocyte retrieval)
• Number of embryos on Day 5 after oocyte retrieval(Day 5 after oocyte retrieval)
• Number of transferred embryos(Up to 28 days)
• Number of transferred blastocysts(Up to 28 days)
• Transfer cancellation rate and reasons for transfer cancellation(Up to 28 days)
• Implantation rate(Up to 28 days)
• Positive beta-human chorionic gonadotropin (βhCG) test rate(11-15 days after transfer)
• Clinical pregnancy rate(4 to 6 weeks after transfer)
• Vital pregnancy rate(4 to 6 weeks after transfer)
• Ongoing pregnancy rate(9 to 11 weeks after transfer)
• Cumulative ongoing pregnancy rate(9 to 11 days)
• Time to pregnancy(4 to 6 weeks after transfer)
• Pregnancy loss rate(Up to 10 - 11 weeks after transfer)
• Live birth rate per initiated stimulation cycles with fresh transfer cycles(More than 20 weeks after transfer)
• Cumulative live birth rate per initiated stimulation cycles(More than 20 weeks after transfer)
• Frequency and severity of adverse drug reactions(During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer)
• Frequency of preventive interventions for early ovarian hyperstimulation syndrome (OHSS)(During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer)
• Frequency of early OHSS(Up to 9 days after triggering of final follicular maturation)
• Frequency of late OHSS(Up to 10-11 weeks after transfer)
• Use of luteinising hormone (LH) surge suppression protocols(Up to 22 days)
• Daily dose of REKOVELLE(Up to 22 days)
• Total dose of REKOVELLE(Up to 22 days)
• Stimulation duration(Up to 22 days)
• Use of any other concomitant ovarian stimulation agent, including daily dose, total dose, and stimulation duration(Up to 22 days)
• Use of follicle maturation triggering protocol(Up to 22 days)