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

NCT07153367 | Recruiting Phase 2

• 1 other identifier: RISE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

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.

Conditions

Infertility; Insemination

Outcome Measures

Primary Outcomes (1)

• Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation

  Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation (follicles diameter ≥14 mm) and no follicles between 10 et 13 mm.

  up to 9 months

Secondary Outcomes (37)

• Number of follicles ≥14 mm on the day of trigger

  Up to Day 15 of the cycle (each cycle is 28 days)

• Number of follicles between 10 et 13 mm on the day of trigger

  Up to Day 15 of the cycle (each cycle is 28 days)

• Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation (follicles diameter ≥14 mm) and no follicles between 10 et 13 mm for each cycle and according to dose adjustment

  up to 9 months

• Presence or absence of dose adjustment in subsequent cycles

  up to 9 months

• E2 level on the day of trigger

  Up to Day 15 of the cycle (each cycle is 28 days)

Study Arms (1)

Rekovelle Arm

EXPERIMENTAL

Drug: REKOVELLE (Follitropin Delta)

Interventions

REKOVELLE (Follitropin Delta) DRUG

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

Rekovelle Arm

Eligibility Criteria

• Age: 18 Years - 38 Years
• Gender Eligibility Details: Des femmes
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Normo-ovulatory patients
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (5)

Cabinet Dr Elodie Descat-Polyclinique Jean Villar

Bruges, 33520, France

RECRUITING

Chi Creteil

Créteil, 94000, France

RECRUITING

Cabinet Dr Géraldine PORCU-Institut de Médecine de la Reproduction

Marseille, 13008, France

RECRUITING

Cabinet Dr Nicolas Chevalier-Centre AMP Saint Roch

Montpellier, 34070, France

RECRUITING

Cabinet Dr Nathalie Massin- Hôpital Américain De Paris

Neuilly-sur-Seine, 92200, France

SUSPENDED

MeSH Terms

Conditions

Infertility

Interventions

follitropin delta

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Nicolas Chevalier

  Centre AMP Saint Roch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aroua Ben Guirat

CONTACT

+33157023710; aroua.benguirat@chicreteil.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: September 4, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): December 17, 2027
• Study Completion (Estimated): March 17, 2028
• Last Updated: April 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)