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RECRUITING

NCT07153367

PHASE2

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

Sponsor: Centre Hospitalier Intercommunal Creteil

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 38 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12-17

Completion Date

2028-03-17

Last Updated

2026-04-08

Healthy Volunteers

Conditions

Infertility Insemination

Interventions

DRUG

REKOVELLE (Follitropin Delta)

Each patient will start the ovarian stimulation with a fixed dose of 3,66 mcg of Rekovelle ® on day 4 of the natural cycle (Stimulation day 1-S1). The stimulation period will last a maximum of 13 days. Patients will be regularly evaluated to monitor the response to stimulation with ultrasound scan and blood sampling

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

Locations (5)

Cabinet Dr Elodie Descat-Polyclinique Jean Villar

Bruges, France

Chi Creteil

Créteil, France

Cabinet Dr Géraldine PORCU-Institut de Médecine de la Reproduction

Marseille, France

Cabinet Dr Nicolas Chevalier-Centre AMP Saint Roch

Montpellier, France

Cabinet Dr Nathalie Massin- Hôpital Américain De Paris

Neuilly-sur-Seine, France