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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT04887402
Eligibility Criteria:
Inclusion Criteria:
* PCOS (based on Rotterdam's criteria: oligo/anovulation, hyperandrogenism clinical (hirsutism or less commonly male pattern alopecia) /biochemical (raised FAI or free testosterone) or polycystic ovaries on ultrasound(presence of 12 or more follicles in each ovary measuring 2-9 mm in diameter, and/or increased ovarian volume (\>10 ml)"1 . Unilaterality does not affect diagnosis; neither does the location of the cysts in the ovary.)
* Age \<40 years.
* Semen analysis within normal according to WHO 2010.
Exclusion Criteria:
* Women on any insulin-sensitizing agent.
* Women on lipid-lowering agent.
* Women with endocrinal disorder (such as thyroid dysfunction, insulin resistance(DM), and adrenal disorders).
* Women diagnosed with anorexia nervosa/bulimia nervosa.
* Women with hypothalamic or pituitary dysfunction.
* Age \>40
* AMH level that does not reflect the phenotype of PCO
Healthy Volunteers:
True
Sex:
FEMALE
Maximum Age:
40 Years
Study:
NCT04887402
Study Brief:
Protocol Section:
NCT04887402