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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT04167033
Eligibility Criteria:
Inclusion Criteria:
Patients with POI
* Patient aged 18 to 41 years
* Patient with POI diagnostic criteria (FSH \>25UI/l twice at intervals of a few weeks) with amenorrhea
* No hormone treatment interacting with the gonadotropic axis for at least one month before inclusion
* Patient who has signed informed consent
* Patient affiliated to a social security system
Healthy volunteers (including POI control group)
* Healthy women, aged 18 to 40 years, age-matched (+/- 5 years), and by BMI class (BMI\<18, 18-25, 25-30, 30-35, 35-40, \>40) compared to women with BPI
* Women with regular cycles of 26 to 32 days
* Women who has signed an informed consent form
* Patient affiliated to a social security system
Exclusion Criteria:
Patients with POI
* Patient on HRT during the 1st evaluation
* Pregnant or breastfeeding woman
* Treatment regimen known to lengthen QT or act on ventricular repolarization
* Cardiac history in particular cardiac rhythm disorder
* Diabetes
* Patient on AME (unless derogation from affiliation),
* Severe renal insufficiency (MDRD \<30ml/min/m²)
Healthy volunteers (including POI control group)
* Diabetes or any chronic disease (including cardiovascular and endocrine)
* Pregnant or breastfeeding woman
* Hormonal contraceptive treatment in progress or stopped less than 3 months ago
* Chronic treatment affecting the duration of QTc
* Woman under AME (unless affiliation derogation)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04167033
Study Brief:
Protocol Section:
NCT04167033