Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT07153367
Eligibility Criteria:
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)
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
38 Years
Study:
NCT07153367
Study Brief:
Protocol Section:
NCT07153367