Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)
NCT ID: NCT07153367
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-12-17
2028-03-17
Brief Summary
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Detailed Description
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Moreover, the main risks currently associated with IUI are multiple pregnancies and iatrogenic complications (cycle cancellation due to insufficient response or excessive response to stimulation more than 3 follicles). It is therefore essential to optimize stimulation treatment protocols to ensure IUI under the best possible conditions.
Due to a precise dose adjustment with Follitropin Delta, the product used in the study (REKOVELLE), for normo-ovulatory patient, an optimal response (bifollicular response) is expected for the majority of patients from the first stimulation. This goal will also facilitate quicker pregnancy attainment and reduce the risk of drop-out and insémination annulation The hypothesis is that this dosage would be efficient and also minimize the risk of multiple pregnancies During the screening visit, the investigator checks the patient's eligibility and informs her about the RISE study. At the inclusion visit, written informed consent is obtained, and the Rekovelle® treatment is explained and initiated. Monitoring visits start on day 9 and then every 2 days until two mature follicles develop. Ovocyte maturation is triggered with an hCG injection, followed by insemination 36 hours later, performed according to routine care. Follow-up visits occur at 6-8 weeks and 13 weeks post-insemination.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rekovelle Arm
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
38 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Centre Hospitalier Intercommunal Creteil
OTHER
Responsible Party
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Principal Investigators
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Nicolas Chevalier
Role: PRINCIPAL_INVESTIGATOR
Centre AMP Saint Roch
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Elodie Descat, Dr
Role: primary
Maud Pasquier, Dr
Role: primary
Géraldine Porcu-Buisson, Dr
Role: primary
Nicolas Chevalier, Dr
Role: primary
Other Identifiers
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RISE
Identifier Type: -
Identifier Source: org_study_id