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

NCT07027332 | Completed

• 1 other identifier: E-54022451-050.04-153866
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycystic Ovary Syndrome; Non-Alcoholic Fatty Liver Disease

Keywords

fibroscan; infertility; Polycystic Ovary Syndrome; Hepatic Steatosis

Outcome Measures

Primary Outcomes (1)

• Liver Steatosis Measured by Controlled Attenuation Parameter (CAP)

  Non-invasive quantification of hepatic steatosis in women with PCOS and controls using FibroScan elastography.

  At baseline (single time point during study visit)

Secondary Outcomes (4)

• Liver Stiffness Measurement (E)

  At baseline (single time point during study visit)

• Insulin Resistance Index (HOMA-IR)

  At baseline (single time point during study visit)

• Hormonal Profiles (FSH, LH, AMH, Total and Free Testosterone)

  At baseline (single time point during study visit)

• Ovarian Volume

  At baseline (single time point during study visit)

Study Arms (2)

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)

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)

Interventions

FibroScan® (Echosens, Paris, France) DIAGNOSTIC_TEST

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); PCOS Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Istanbul, 34035, Turkey (Türkiye)

Location

Related Publications (7)

• Kara O, Arsoy HA, Keskin M. Relationship between nonalcoholic fatty liver disease and hyperandrogenemia in adolescents with polycystic ovary syndrome. Clin Exp Pediatr. 2023 Sep;66(9):395-402. doi: 10.3345/cep.2023.00353. Epub 2023 Jun 14.

  PMID: 37321582 BACKGROUND

• Macut D, Tziomalos K, Bozic-Antic I, Bjekic-Macut J, Katsikis I, Papadakis E, Andric Z, Panidis D. Non-alcoholic fatty liver disease is associated with insulin resistance and lipid accumulation product in women with polycystic ovary syndrome. Hum Reprod. 2016 Jun;31(6):1347-53. doi: 10.1093/humrep/dew076. Epub 2016 Apr 12.

  PMID: 27076501 BACKGROUND

• Taranto DOL, Guimaraes TCM, Couto CA, Candido AL, Azevedo RCS, Mattos FS, Elias MLC, Reis FM, Rocha ALL, Faria LC. Nonalcoholic fatty liver disease in women with polycystic ovary syndrome: associated factors and noninvasive fibrosis staging in a single Brazilian center. Arch Endocrinol Metab. 2020 May-Jun;64(3):235-242. doi: 10.20945/2359-3997000000242.

  PMID: 32555989 BACKGROUND

• Petta S, Ciresi A, Bianco J, Geraci V, Boemi R, Galvano L, Magliozzo F, Merlino G, Craxi A, Giordano C. Insulin resistance and hyperandrogenism drive steatosis and fibrosis risk in young females with PCOS. PLoS One. 2017 Nov 21;12(11):e0186136. doi: 10.1371/journal.pone.0186136. eCollection 2017.

  PMID: 29161258 BACKGROUND

• Chen W, Pang Y. Metabolic Syndrome and PCOS: Pathogenesis and the Role of Metabolites. Metabolites. 2021 Dec 14;11(12):869. doi: 10.3390/metabo11120869.

  PMID: 34940628 BACKGROUND

• Migacz M, Pluta D, Baranski K, Krajewski B, Madej P, Holecki M. Using non-invasive indicators to screen the PCOS population for liver disease - a single-centre study. Endokrynol Pol. 2025;76(1):94-99. doi: 10.5603/ep.101901.

  PMID: 40071805 BACKGROUND

• Chakraborty S, Ganie MA, Masoodi I, Jana M; Shalimar; Gupta N, Sofi NY. Fibroscan as a non-invasive predictor of hepatic steatosis in women with polycystic ovary syndrome. Indian J Med Res. 2020 Apr;151(4):333-341. doi: 10.4103/ijmr.IJMR_610_18.

  PMID: 32461397 RESULT

Related Links

• Study examining the relationship between nonalcoholic fatty liver disease and hyperandrogenemia in adolescents with PCOS.
• Research on the association of NAFLD with insulin resistance and lipid accumulation in women with PCOS.

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Non-alcoholic Fatty Liver Disease; Infertility; Fatty Liver

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Liver Diseases; Digestive System Diseases

Study Officials

• Zeynep Gayhan, Medicine

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 18, 2025
• Study Start: May 29, 2024
• Primary Completion: January 30, 2025
• Study Completion: March 8, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

TU (1)