Fixed 3.66 mcg Rekovelle (follitropin delta) for ovarian stimulation before intrauterine insemination

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study gives a single fixed dose of 3.66 mcg follitropin delta (Rekovelle) to normo-ovulatory women undergoing their first intrauterine insemination. Treatment is started at inclusion and follicular development is monitored beginning on day 9 and then every two days until two mature follicles develop. Ovulation is triggered with hCG and insemination is performed 24–36 hours later. The main goal is to achieve a controlled bifollicular response while minimizing cycle cancellations and the risk of multiple pregnancies.

Why it matters

Who can join: the full rules

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

Where it's running

• Cabinet Dr Elodie Descat-Polyclinique Jean Villar
  Bruges, France Recruiting
• Chi Creteil
  Créteil, France Recruiting
• Cabinet Dr Géraldine PORCU-Institut de Médecine de la Reproduction
  Marseille, France Recruiting
• Cabinet Dr Nicolas Chevalier-Centre AMP Saint Roch
  Montpellier, France Recruiting
• Cabinet Dr Nathalie Massin- Hôpital Américain De Paris
  Neuilly-sur-Seine, France Suspended

Study contacts

• Principal investigator: Nicolas Chevalier — Centre AMP Saint Roch
• Study coordinator: Aroua Ben Guirat
• Email: aroua.benguirat@chicreteil.fr
• Phone: +33157023710

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.