NCT07153367 Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)
| NCT ID | NCT07153367 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre Hospitalier Intercommunal Creteil |
| Condition | Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-12-17 |
| Primary Completion | 2027-12-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2025-12-17 with a primary completion date of 2027-12-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, persons deprived of liberty, and persons unable to give consent) * Tumors (including meningioma) whose development is known or suspected to be progesterone-dependent * History of hepatic dysfunction * Have been receiving progestogen therapy for more than 6 months * Known contraindication to hormonal treatments (progestogens or oestrogens), or with a history of adverse events related to their use * Previous thromboembolism events during or following the use of gonadotrophins or with high risk factors for thromboembolic events (venous or arterial) * Previous or current treatment with gonadotrophins * Hypersensitivity to the active substance or to any of the excipients * High risk of OHSS such as women with AMH ≥ 35 pmol/L * History of severe uterine malformation (unicornuate or bicornuate uterus), * Past history of ovarian torsion * Uncontrolled thyroid dysfunction * Uncontrolled adrenal dysfunction * Hydrosalpynx * Breast pathologies not compatible with gonadotrophin stimulation * Use of infertility medications that could affect follicle stimulation and maturation such as GH * Participation in other interventional research * Not able to understand and sign the written informed consent form
Contact & Investigator
Nicolas Chevalier
PRINCIPAL INVESTIGATOR
Centre AMP Saint Roch
Frequently Asked Questions
Who can join the NCT07153367 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 38 Years, studying Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07153367 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07153367 currently recruiting?
Yes, NCT07153367 is actively recruiting participants. Contact the research team at aroua.benguirat@chicreteil.fr for enrollment information.
Where is the NCT07153367 trial being conducted?
This trial is being conducted at Bruges, France, Créteil, France, Marseille, France, Montpellier, France and 1 additional location.
Who is sponsoring the NCT07153367 clinical trial?
NCT07153367 is sponsored by Centre Hospitalier Intercommunal Creteil. The principal investigator is Nicolas Chevalier at Centre AMP Saint Roch. The trial plans to enroll 80 participants.