Status:
RECRUITING
Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)
Lead Sponsor:
Centre Hospitalier Intercommunal Creteil
Collaborating Sponsors:
Ferring Pharmaceuticals
Conditions:
Infertility
Insemination
Eligibility:
FEMALE
18-38 years
Phase:
PHASE2
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 assump...
Detailed Description
Intrauterine insemination (IUI) is a frequently used step in the management of unexplained infertility or mild fertility disorders. In normal-weight patients, the main objective of ovarian stimulation...
Eligibility Criteria
Inclusion
- 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
- 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)
- 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
Key Trial Info
Start Date :
December 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 17 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07153367
Start Date
December 17 2025
End Date
March 17 2028
Last Update
December 22 2025
Active Locations (5)
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1
Cabinet Dr Elodie Descat-Polyclinique Jean Villar
Bruges, France, 33520
2
Chi Creteil
Créteil, France, 94000
3
Cabinet Dr Géraldine PORCU-Institut de Médecine de la Reproduction
Marseille, France, 13008
4
Cabinet Dr Nicolas Chevalier-Centre AMP Saint Roch
Montpellier, France, 34070