About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Normo-ovulatory patients
18 - 38 included years old
BMI between 18 and 29 included kg/m²
Regular menstrual cycles
Disqualifiers
Endometriosis Stage III
Total mobile sperm count <1 million
Severe spermatogenesis disorders
Women with Poly Cystic Ovary Syndrom
Trial design
Single group
Treatments tested in this trial
REKOVELLE (Follitropin Delta)
DrugEach 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
Treatment groups
Trial outcomes
Primary outcomes
Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation
Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation (follicles diameter ≥14 mm) and no follicles between 10 et 13 mm.
Secondary outcomes
Number of follicles ≥14 mm on the day of trigger
Number of follicles ≥14 mm on the day of trigger ( by cycle)
Number of follicles between 10 et 13 mm on the day of trigger
Number of follicles between 10 et 13 mm on the day of trigger (by cycle)
Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation (follicles diameter ≥14 mm) and no follicles between 10 et 13 mm for each cycle and according to dose adjustment
Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation (follicles diameter ≥14 mm) and no follicles between 10 et 13 mm for each cycle and according to dose adjustment
Presence or absence of dose adjustment in subsequent cycles
Presence or absence of dose adjustment in subsequent cycles
Sponsors and contacts
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Centre Hospitalier Intercommunal Creteil
Lead sponsor
Ferring Pharmaceuticals
Collaborator