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 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT07027332
Eligibility Criteria:
Inclusion Criteria:
* Female participants aged 18 to 45 years
* Voluntary participation and signed informed consent
* For the PCOS group: diagnosis of Polycystic Ovary Syndrome (PCOS) based on the Rotterdam 2003 criteria, including at least two of the following: (1) oligo- or anovulation, (2) clinical or biochemical hyperandrogenism, (3) polycystic ovarian morphology on ultrasound
* For the control group: regular menstrual cycles in the past two years and absence of clinical or biochemical hyperandrogenism
* No history of endocrine, metabolic, hepatic, renal, cardiovascular, or oncologic disease
* Willingness and ability to undergo blood sampling, ultrasound, and FibroScan evaluations
* Ability to comply with study procedures and availability throughout the study period
Exclusion Criteria:
* Pregnancy or lactation
* Use of hormonal contraceptives, insulin sensitizers, or hepatotoxic medications within the past 3 months
* Diagnosis of diabetes mellitus, thyroid dysfunction, Cushing's syndrome, or congenital adrenal hyperplasia
* ALT ≥2 times the upper limit of normal (ULN) or single ALT \>80 U/L at screening
* Positive screening for hepatitis B surface antigen (HBsAg), hepatitis C virus RNA (HCV RNA), or HIV
* History or current diagnosis of liver disease, autoimmune hepatitis, Wilson's disease, or alpha-1 antitrypsin deficiency
* Alcohol intake exceeding 20 grams per day
* Presence of ovarian cysts, endometriomas, or adnexal masses interfering with ultrasound interpretation
* Personal or first-degree family history of liver cancer or any malignancy
* Inability to understand or sign informed consent or to adhere to study requirements
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07027332
Study Brief:
Protocol Section:
NCT07027332