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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT05272657
Eligibility Criteria:
Inclusion Criteria:
* Women with PCOS between the ages of 18-40 years and with a body mass index of less than or equal to 45.
* Fulfillment of at least two of the following three criteria for PCOS, adopted by the Rotterdam Consensus in 2003 (Rotterdam ESHRE / ASRM-Sponsored PCOS Consensus Workshop Group):
* signs of hyperandrogenemia - clinical and / or biochemical (increase in the index of free androgens or total testosterone)
* signs of chronic anovulation
* ultrasound signs: the number of follicles in the ovary ≥ 20 and / or ovarian volume ≥ 10 ml in any ovary in the case of gynecological age 8 or more years after menarche.
Exclusion Criteria:
* The presence of hyperprolactinemia
* Cushing's syndrome
* Ongenital hyperplasia of the adrenal cortex
* Hypothyroidism
* Androgen-producing tumors
* Regular use of drugs and dietary supplements that affect the function of the ovaries
* Adrenal glands
* Metabolism of carbohydrates
* Lipids
* Microbiota composition during the 2 months preceding the study
* Pregnancy
* Lactation
* Significant comorbidities
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
44 Years
Study:
NCT05272657
Study Brief:
Protocol Section:
NCT05272657