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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-38
SponsorCentre Hospitalier Intercommunal Creteil

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

Qualifiers

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

Treatments tested in this trial

  • REKOVELLE (Follitropin Delta)

Treatment groups

80 Participants
are divided into 1 treatment group

Sponsors and collaborators

Centre Hospitalier Intercommunal Creteil

Lead sponsor

Ferring Pharmaceuticals

Collaborator