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Recruiting Phase 2 NCT07153367

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

Trial Parameters

Condition Infertility
Sponsor Centre Hospitalier Intercommunal Creteil
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 80
Sex FEMALE
Min Age 18 Years
Max Age 38 Years
Start Date 2025-12-17
Completion 2027-12-17
Interventions
REKOVELLE (Follitropin Delta)

Brief 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 Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Endometriosis Stage III * Total mobile sperm count \<1 million * Severe spermatogenesis disorders * Women with Poly Cystic Ovary Syndrom * History of OHSS or excessive response to gonadotrophins * Chronic disease with contraindication to ovarian stimulation with gonadotrophins * Known genetic disease * Hypothalamus or pituitary tumors * Ovarian hypertrophy or ovarian cyst not due to polycystic ovary syndrome * Gynecological bleeding of unknown etiology * Ovarian, uterine or breast carcinoma * Primary ovarian failure * Genital malformations incompatible with pregnancy * Uterine fibroids incompatible with pregnancy * Protected persons (pregnant women, nursing mothers, person under guardianship, minors, pe

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