Fixed Dose of Follitropin Delta Rekovelle for Ovarian Stimulation in Intrauterine Insemination to Improve Pregnancy Outcomes and Reduce Multiple Pregnancies

What this Trial Is About

Researchers are evaluating the use of a fixed dose of 3.66 mcg of follitropin delta Rekovelle to stimulate the ovaries during intrauterine insemination IUI in women with infertility. The study aims to optimize ovarian response by promoting the development of two follicles, which may improve the chances of pregnancy while minimizing the risk of multiple pregnancies and treatment complications. This phase 2 study builds on previous findings supporting follitropin deltas use in assisted reproductive techniques like IVF and ICSI, focusing on patients with regular menstrual cycles and normal ovulation. Participants will begin ovarian stimulation with Rekovelle on day 4 of their natural menstrual cycle, continuing stimulation for up to 13 days. Regular monitoring using ultrasound and blood tests will track follicle development. When two mature follicles are identified, ovulation will be triggered with an hCG injection, followed by insemination 24 to 36 hours later. The study includes initial screening and consent visits, monitoring visits every two days starting on day 9 of stimulation, and follow-up visits 6-8 and 13 weeks after insemination. During the study, researchers will assess ovarian response by measuring the percentage of cycles with two mature follicles at ovulation trigger and track various hormonal levels, pregnancy rates, cycle cancellations, and pregnancy outcomes. Participants will undergo ultrasound scans and blood sampling for hormone levels, with safety monitored over nine months. The overall goal is to achieve pregnancy more quickly with fewer complications, providing a more comfortable treatment experience while carefully tracking all outcomes and any adverse events.

Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)