Fixed 3.66 mcg Rekovelle (follitropin delta) for ovarian stimulation before intrauterine insemination
Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)
This test tries a fixed 3.66 mcg dose of Rekovelle (follitropin delta) to stimulate the ovaries of women 18–38 with regular cycles undergoing their first IUI to encourage two follicles and reduce the chance of multiple pregnancy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 38 Years |
| Sex | Female |
| Sponsor | Centre Hospitalier Intercommunal Creteil Academic / other |
| Locations | 5 sites (Bruges and 4 other locations) |
| Trial ID | NCT07153367 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional study gives a single fixed dose of 3.66 mcg follitropin delta (Rekovelle) to normo-ovulatory women undergoing their first intrauterine insemination. Treatment is started at inclusion and follicular development is monitored beginning on day 9 and then every two days until two mature follicles develop. Ovulation is triggered with hCG and insemination is performed 24–36 hours later. The main goal is to achieve a controlled bifollicular response while minimizing cycle cancellations and the risk of multiple pregnancies.
Who should consider this trial
Good fit: Ideal candidates are normo-ovulatory women aged 18–38 with BMI 18–29, regular menstrual cycles, at least one healthy fallopian tube, a normal uterine cavity, and who are undergoing their first IUI.
Not a fit: Women with PCOS, severe male-factor infertility (very low sperm counts), prior excessive response to gonadotrophins or OHSS history, major chronic disease contraindicating stimulation, or certain gynecologic or genetic conditions are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this approach could simplify dosing, speed time to pregnancy, and lower the risk of multiple pregnancies and treatment cancellations.
How similar studies have performed: Rekovelle has demonstrated efficacy for controlled ovarian stimulation in IVF/ICSI and at least one recent study supports its use in IUI, but use of this specific fixed 3.66 mcg dose for first-attempt IUI is being specifically confirmed here.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bruges and 4 other locations
- Cabinet Dr Elodie Descat-Polyclinique Jean Villar — Bruges, France (Recruiting)
- Chi Creteil — Créteil, France (Recruiting)
- Cabinet Dr Géraldine PORCU-Institut de Médecine de la Reproduction — Marseille, France (Recruiting)
- Cabinet Dr Nicolas Chevalier-Centre AMP Saint Roch — Montpellier, France (Recruiting)
- Cabinet Dr Nathalie Massin- Hôpital Américain De Paris — Neuilly-sur-Seine, France (Suspended)
Study contacts
- Principal investigator: Nicolas Chevalier — Centre AMP Saint Roch
- Study coordinator: Aroua Ben Guirat
- Email: aroua.benguirat@chicreteil.fr
- Phone: +33157023710
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.