Clinical Trial

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

Study acronym: RISE
Recruiting Phase 2
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Summary
The aim of this study is to evaluate the use of a fixed dose of 3.66 mcg of follitropin delta (Rekovelle) on ovarian response during ovarian stimulation for intrauterine insemination (IUI). The assumption is that this fixed dose will be effective while minimizing the risk of multiple pregnancies. A recent study demonstrated the efficacy of follitropin delta for ovarian stimulation in IUI, and it has been approved in France for controlled ovarian stimulation in assisted reproductive techniques such as in vitro fertilization (IVF) and IVF with intracytoplasmic sperm injection (ICSI). With an adapted dose of Rekovelle for patients with regular menstrual cycles, ovarian stimulation is optimized from the first attempt, promoting the development of two follicles to improve pregnancy chances while reducing the risk of multiple pregnancies. This approach aims to achieve pregnancy faster and provide a more comfortable treatment experience.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-08-29; most recent amendment 2026-04-03.
Status change: Not Yet Recruiting → Recruiting 2025-12-09
Trial Details
NCT Number NCT07153367
Lead Sponsor Centre Hospitalier Intercommunal Creteil
Collaborators: Ferring Pharmaceuticals
Conditions Infertility, Insemination
Enrollment 80 participants
Start Date 2025-12-17
Primary Completion 2027-12-17 (estimated)
Study Completion 2028-03-17 (estimated)
Updated on ClinicalTrials.gov 2026-04-08