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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 38
Healthy Volunteers: f
View:

• Normo-ovulatory patients

• 18 - 38 included years old

• BMI between 18 and 29 included kg/m²

• Regular menstrual cycles

• At least one healthy Fallopian tube

• Normal uterus cavity

• First treatment for IUI

• Affiliation to the social security

Locations
Other Locations
France
Cabinet Dr Elodie Descat-Polyclinique Jean Villar
RECRUITING
Bruges
Chi Creteil
RECRUITING
Créteil
Cabinet Dr Géraldine PORCU-Institut de Médecine de la Reproduction
RECRUITING
Marseille
Cabinet Dr Nicolas Chevalier-Centre AMP Saint Roch
RECRUITING
Montpellier
Cabinet Dr Nathalie Massin- Hôpital Américain De Paris
SUSPENDED
Neuilly-sur-seine
Contact Information
Primary
Aroua Ben Guirat
aroua.benguirat@chicreteil.fr
+33157023710
Time Frame
Start Date: 2025-12-17
Estimated Completion Date: 2028-03-17
Participants
Target number of participants: 80
Treatments
Experimental: Rekovelle Arm
Related Therapeutic Areas
Sponsors
Collaborators: Ferring Pharmaceuticals
Leads: Centre Hospitalier Intercommunal Creteil

This content was sourced from clinicaltrials.gov