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

Sponsor
Centre Hospitalier Intercommunal Creteil
Study ID
NCT07153367
Phase
PHASE2
Status
Recruiting
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Conditions

  • Infertility
  • Insemination

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 38 Years
Healthy Volunteers
Not accepted

Interventions

  • REKOVELLE (Follitropin Delta) — DRUG
    Each patient will start the ovarian stimulation with a fixed dose of 3,66 mcg of Rekovelle ® on day 4 of the natural cycle (Stimulation day 1-S1). The stimulation period will last a maximum of 13 days. Patients will be regularly evaluated to monitor the response to stimulation with ultrasound scan and blood sampling

Study Details

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.

Key Dates

First listed
Sep 4, 2025
Start date
Dec 17, 2025
Status verified
Dec 2025
Primary completion
Dec 17, 2027
Completion
Mar 17, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rekovelle Arm

Primary Outcome Measure

Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation [ Time Frame: up to 9 months ]

Central Contacts

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