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 range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Polycystic Ovary Syndrome trials