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

Study acronym: RISE
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria expanded, about 6 words
    • Study description expanded, about 2 words
    v5
  2. Site details revised at 1 of 5 sitesv4
  3. Primary completion date: Jun 1, 2027 to Dec 17, 2027
    • Study completion date: Dec 1, 2027 to Mar 17, 2028
    • Start date changed from estimate of Dec 15, 2025 to Dec 17, 2025
    • Site details revised at 2 of 5 sites
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 1, 2025 to Dec 15, 2025
    • Site details revised at 5 of 5 sites
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07153367
Lead Sponsor Centre Hospitalier Intercommunal Creteil
Collaborators: Ferring Pharmaceuticals
Conditions
(from sponsor)		 Infertility, Insemination
Related terms Infertility
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov