Actively Recruiting

Phase 2
Age: 18Years - 38Years
FEMALE
NCT07153367

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

Led by Centre Hospitalier Intercommunal Creteil · Updated on 2026-04-08

80

Participants Needed

5

Research Sites

117 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Intercommunal Creteil

Lead Sponsor

F

Ferring Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 38Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Normo-ovulatory patients
  • Aged 18 to 38 years old
  • Body mass index (BMI) between 18 and 29 kg/m�b2
  • Regular menstrual cycles
  • At least one healthy Fallopian tube
  • Normal uterus cavity
  • First treatment for intrauterine insemination (IUI)
  • Affiliated with social security
Not Eligible

You will not qualify if you...

  • Stage III endometriosis
  • Total mobile sperm count less than 1 million
  • Severe spermatogenesis disorders
  • Diagnosis of polycystic ovary syndrome
  • History of ovarian hyperstimulation syndrome (OHSS) or excessive response to gonadotrophins
  • Chronic diseases contraindicating ovarian stimulation with gonadotrophins
  • Known genetic diseases
  • Hypothalamus or pituitary tumors
  • Ovarian hypertrophy or ovarian cysts not due to polycystic ovary syndrome
  • Gynecological bleeding of unknown cause
  • Ovarian, uterine, or breast cancer
  • Primary ovarian failure
  • Genital malformations incompatible with pregnancy
  • Uterine fibroids incompatible with pregnancy
  • Pregnant women, nursing mothers, persons under guardianship, minors, persons deprived of liberty, or unable to give consent
  • Tumors suspected to be progesterone-dependent
  • History of liver dysfunction
  • Receiving progestogen therapy for more than 6 months
  • Known contraindication or adverse events related to hormonal treatments
  • Previous thromboembolism events or high risk factors for thromboembolic events
  • Previous or current treatment with gonadotrophins
  • Hypersensitivity to active substance or excipients
  • High risk of OHSS (AMH �b9�b2 35 pmol/L or higher)
  • Severe uterine malformation history
  • Past ovarian torsion
  • Uncontrolled thyroid or adrenal dysfunction
  • Hydrosalpinx
  • Breast conditions incompatible with gonadotrophin stimulation
  • Use of infertility medications affecting follicle stimulation
  • Participation in other interventional research
  • Unable to understand or sign informed consent form

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Cabinet Dr Elodie Descat-Polyclinique Jean Villar

Bruges, France, 33520

Actively Recruiting

2

Chi Creteil

Créteil, France, 94000

Actively Recruiting

3

Cabinet Dr Géraldine PORCU-Institut de Médecine de la Reproduction

Marseille, France, 13008

Actively Recruiting

4

Cabinet Dr Nicolas Chevalier-Centre AMP Saint Roch

Montpellier, France, 34070

Actively Recruiting

5

Cabinet Dr Nathalie Massin- Hôpital Américain De Paris

Neuilly-sur-Seine, France, 92200

Suspended

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Research Team

A

Aroua Ben Guirat

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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