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:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT06150703
Eligibility Criteria:
Inclusion Criteria:
* Patients requiring conventional IVF or IVF with sperm injection (ICSI) from the partner or donor under the conditions of management defined by French law.
* Patients aged 18 to 39 included
* First or second attempt at IVF or ICSI for pregnancy
* BMI \< 35 kg/m2
* Anti-Mullerian hormone (AMH) \> 1 ng/ml (= 7 pmol/L) and/or antral follicle count ≥ 8 within the year prior to inclusion
* AMH \< 5 ng/ml and/or antral follicle count \<40 within the year prior to inclusion
* Treatment with recombinant FSH
* Antagonist protocol (with pre-treatment or not)
* Initial dose of recombinant FSH between 75 and 450 IU
* Signed informed consent
* Affiliation to the social security system (excluding AME)
Exclusion Criteria:
* Patient diagnosed with HIV infection
* ICSI with sperm from testicular biopsy
* Pre-implantation diagnosis
* Hypogonadotropic hypogonadism (amenorrhea or spaniomenorrhea with basal LH \<1.2 IU/L)
* History of severe ovarian hyperstimulation syndrome (OHSS)
* Unoperated hydrosalpinx
* Intracavitary polyps or myomas deforming the cavity
* Known hypersensitivity to the investigational drugs and/or their excipients (human chorionic gonadotropin, progesterone, nafarelin acetate, GnRH, GnRH analogues, mannitol, sodium chloride, water for injection, glacial acetic acid, Sodium hydroxide and/or hydrochloric acid, sorbitol, purified water, benzalkonium chloride, sunflower oil, soybean lecithin, gelatin, glycerol, titanium dioxide (E171), methionine, poloxamer 18, phosphoric acid).
* Gynaecological bleeding or genital haemorrhage
* History of epilepsy and/or intracranial tumors potentially causing epilepsy
* Tumours of the hypothalamus or pituitary gland
* Ovarian enlargement or cysts unrelated to polycystic ovary syndrome
* Severe adenomyosis requiring a long protocol
* Carcinoma of the ovary, uterus or breast
* Active thromboembolic events
* Severe impairment of liver function
* Breastfeeding women
* Patients under court protection, guardianship or curators
* Current participation in another therapeutic interventional trial on the day of inclusion
* Patients who do not speak or understand French
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT06150703
Study Brief:
Protocol Section:
NCT06150703