Study of Personalized Dosing of Follitropin Delta REKOVELLE and HP-hMG MENOPUR for Ovarian Stimulation in Women Undergoing IVF Aged 18 to 40

What this Trial Is About

Researchers are evaluating a personalized ovarian stimulation regimen for women aged 18 to 40 undergoing in vitro fertilization IVF. This study aims to determine if adjusting the starting doses of follitropin delta REKOVELLE and highly purified human menopausal gonadotropin HP-hMG or MENOPUR based on age and body weight results in similar clinical outcomes as dosing based on anti-Mllerian hormone AMH and weight. This phase II interventional trial builds on previous studies showing benefits of combining these hormones for ovarian stimulation. Participants will receive a combination therapy where REKOVELLE dosing is personalized according to age, and MENOPUR dosing is determined based on the REKOVELLE dose and body weight. This differs from earlier protocols that used fixed doses. Throughout the treatment, participants will undergo ovarian stimulation followed by standard IVF procedures including egg retrieval and embryo assessment. During the study, participants will be monitored through ultrasound imaging and blood tests to measure hormone levels such as estradiol. The main measurement is the number of good quality or usable blastocysts five to six days after egg retrieval. Safety outcomes, including the risk of ovarian hyperstimulation syndrome, will also be tracked up to 15 days post-retrieval. The trial is designed to assess the feasibility and safety of this new dosing approach over the course of one treatment cycle.

Menopur And Rekovelle Combination Study Version 2.0