CompletedNot Applicable

Liver Stiffness And Steatosis Assessment In Women With Polycystic Ovary Syndrome Using Fibroscan

Turkey (Türkiye)36 participantsStarted 2024-05-29

Plain-language summary

Polycystic Ovary Syndrome (PCOS) is a complex endocrine and metabolic disorder prevalent among women of reproductive age. It is closely associated with insulin resistance, obesity, and metabolic dysfunction, often leading to hepatic steatosis (fatty liver). This single-center, cross-sectional, case-control study evaluates liver function in PCOS patients using FibroScan, a non-invasive elastography technique. Eighteen women diagnosed with PCOS according to Rotterdam criteria and 18 age- and BMI-matched healthy controls aged 18-45 years were included. The study aims to determine whether PCOS independently affects hepatic steatosis and to assess the clinical applicability of FibroScan in this population. The results may inform early metabolic risk detection and improve multidisciplinary management strategies for PCOS.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 interpretatio…

What they're measuring

Liver Steatosis Measured by Controlled Attenuation Parameter (CAP)

Timeframe: At baseline (single time point during study visit)

Trial details

NCT IDNCT07027332

SponsorBezmialem Vakif University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-30