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

June 16, 2025 updated by: Bezmialem Vakif University

Assesment of Liver Functions in Women With Polycystic Ovary Syndrome Using Fibroscan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective, cross-sectional study was conducted at Bezmialem Vakif University Hospital. The study included 36 women between the ages of 18 and 45. Eighteen participants were diagnosed with Polycystic Ovary Syndrome (PCOS) according to the Rotterdam 2003 criteria, which require at least two of the following features: oligo- or anovulation, clinical or biochemical hyperandrogenism, or polycystic ovarian morphology, with other endocrine disorders excluded. The remaining 18 participants, matched for age and body mass index (BMI), constituted the healthy control group.

All evaluations were conducted according to a standardized protocol approved by the university ethics committee. Each participant underwent physical examination and anthropometric assessment, including measurement of height, weight, waist and hip circumferences, and calculation of BMI and waist-to-hip ratio. Clinical hyperandrogenism was assessed using the modified Ferriman-Gallwey score by an experienced gynecologist. Participants were also evaluated for acne and androgenic alopecia. Pelvic ultrasonography was performed transabdominally or transvaginally between days 2 and 5 of the menstrual cycle, depending on anatomical and personal factors. Ovarian volume was calculated using the ellipsoid formula, and participants with structural abnormalities or dominant follicles larger than 10 mm were excluded.

Fasting venous blood samples were collected after a 13-hour overnight fast. Biochemical tests included fasting glucose, insulin, lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides), liver function tests including AST (aspartate aminotransferase), ALT (alanine aminotransferase), ALP (alkaline phosphatase), GGT (gamma-glutamyl transferase), and bilirubin fractions. Renal function markers included creatinine, blood urea nitrogen, and estimated glomerular filtration rate. Additional measurements included albumin, uric acid, and platelet count. Thyroid function was assessed with thyroid-stimulating hormone (TSH), free triiodothyronine (free T3), and free thyroxine (free T4). Hormonal assays, performed between days 3 and 5 of the menstrual cycle, included follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), anti-Müllerian hormone (AMH), total and free testosterone, sex hormone-binding globulin (SHBG), prolactin, and the free androgen index. Insulin resistance was calculated using the HOMA-IR formula.

Liver steatosis and stiffness were measured using Vibration-Controlled Transient Elastography (FibroScan®, Echosens, Paris) following at least 12 hours of fasting. All procedures were performed by a senior hepatologist blinded to the clinical and laboratory findings. CAP (Controlled Attenuation Parameter) values were used to evaluate hepatic fat content, and liver stiffness was measured in kilopascals (kPa). Measurements followed strict quality control standards including a minimum of 10 valid acquisitions, a success rate of 60% or higher, and an interquartile-to-median ratio of 0.30 or lower. CAP and stiffness cut-off values were applied according to published clinical thresholds.

To exclude secondary hepatic or endocrine conditions, all participants were screened for viral hepatitis (HBsAg, Anti-HCV, HCV RNA), HIV (Anti-HIV ELISA), and abnormal thyroid or renal function. Individuals with a history of liver disease, viral hepatitis, hepatotoxic drug use, ALT levels greater than twice the upper limit of normal for more than three months, or a personal or first-degree family history of liver cancer or autoimmune liver disorders were excluded. Pregnant or breastfeeding women were also not included.

The aim of this study is to evaluate whether PCOS independently contributes to hepatic steatosis, beyond known factors such as obesity and insulin resistance, and to assess the clinical utility of FibroScan as a non-invasive liver assessment tool in this patient population.

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34035
        • Bezmialem Vakıf University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This single-center, cross-sectional, comparative study was conducted at Bezmialem Vakif University Hospital. The study population consists of women aged 18 to 45 years diagnosed with PCOS according to Rotterdam criteria and age- and BMI-matched healthy controls without endocrine or metabolic disorders.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PCOS Group
Women aged 18 to 45 diagnosed with Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria. Participants presented with symptoms such as menstrual irregularities, acne, or hirsutism. Exclusion criteria included alcohol consumption >20 g/day, liver disease history, pregnancy, lactation, and medication affecting liver/metabolism. Evaluations included anthropometric measurements (BMI, waist and hip circumference, waist-to-hip ratio), laboratory analyses (fasting glucose, insulin, lipid profile, liver enzymes, bilirubin fractions), hormonal assays (FSH, LH, AMH, estradiol, total and free testosterone, SHBG), ovarian ultrasonography (transabdominal or transvaginal), and liver assessment via FibroScan elastography. No interventions were administered as this was an observational study.
Diagnostic test: FibroScan® (Echosens, Paris, France)
A non-invasive liver elastography device used for clinical assessment. Liver steatosis and stiffness are measured in participants using the FibroScan device.
Control Group ( Healthy, NON PCOS)
Age and BMI matched healthy women aged 18 to 45 with regular menstruation for at least two years, no clinical signs of hyperandrogenism, and no history of endocrine, hepatic, renal, cardiovascular, or oncologic diseases. Participants underwent the same evaluations as the PCOS group, including anthropometric measurements, laboratory and hormonal assays, ovarian ultrasonography, and FibroScan liver elastography. No interventions were administered.
Diagnostic test: FibroScan® (Echosens, Paris, France)
A non-invasive liver elastography device used for clinical assessment. Liver steatosis and stiffness are measured in participants using the FibroScan device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver Steatosis Measured by Controlled Attenuation Parameter (CAP)
Time Frame: At baseline (single time point during study visit)
Non-invasive quantification of hepatic steatosis in women with PCOS and controls using FibroScan elastography.
At baseline (single time point during study visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver Stiffness Measurement (E)
Time Frame: At baseline (single time point during study visit)
Assessment of liver fibrosis via liver stiffness measurement using FibroScan in PCOS and control groups.
At baseline (single time point during study visit)
Insulin Resistance Index (HOMA-IR)
Time Frame: At baseline (single time point during study visit)
Calculated insulin resistance based on fasting glucose and insulin levels in study participants.
At baseline (single time point during study visit)
Hormonal Profiles (FSH, LH, AMH, Total and Free Testosterone)
Time Frame: At baseline (single time point during study visit)
Measurement of key reproductive hormone levels by electrochemiluminescence immunoassay to assess endocrine function in PCOS and control groups.
At baseline (single time point during study visit)
Ovarian Volume
Time Frame: At baseline (single time point during study visit)
Ovarian volume measured by standardized transabdominal or transvaginal ultrasonography using the ellipsoid formula.
At baseline (single time point during study visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Principal Investigator: Zeynep Gayhan, Medicine, Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2024

Primary Completion (Actual)

January 30, 2025

Study Completion (Actual)

March 8, 2025

Study Registration Dates

First Submitted

May 28, 2025

First Submitted That Met QC Criteria

June 16, 2025

First Posted (Actual)

June 18, 2025

Study Record Updates

Last Update Posted (Actual)

June 18, 2025

Last Update Submitted That Met QC Criteria

June 16, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-54022451-050.04-153866

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

At this time, a definitive plan for sharing individual participant data (IPD) has not been finalized. The study team acknowledges the importance of data sharing for scientific transparency and collaboration and will evaluate the feasibility and ethical considerations related to IPD sharing following study completion. Any future plans for data sharing will comply with applicable privacy regulations and institutional policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Polycystic Ovary Syndrome

Clinical Trials on FibroScan® (Echosens, Paris, France)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe