NCT07027332Completed
Liver Stiffness And Steatosis Assessment In Women With Polycystic Ovary Syndrome Using Fibroscan
Assesment of Liver Functions in Women With Polycystic Ovary Syndrome Using Fibroscan
Source: ClinicalTrials.gov · Last updated 18 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 36 (actual)
- First submitted
- 28 May 2025
- Start date
- 29 May 2024
- Primary completion date
- 30 Jan 2025
- Lead sponsor
- Bezmialem Vakif University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07027332
What you commit to
- Study type: Observational
- Participants enrolled: 36
- From 29 May 2024 to the primary completion date, 30 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of hormonal contraceptives, insulin sensitizers, or hepatotoxic medications within the past 3 months
Other illness
- Diagnosis of diabetes mellitus, thyroid dysfunction, Cushing's syndrome, or congenital adrenal hyperplasia
- 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
- Personal or first-degree family history of liver cancer or any malignancy
Lab values
- ALT ≥2 times the upper limit of normal (ULN) or single ALT \>80 U/L at screening
Other
- Pregnancy or lactation
- Alcohol intake exceeding 20 grams per day
- Presence of ovarian cysts, endometriomas, or adnexal masses interfering with ultrasound interpretation
- Inability to understand or sign informed consent or to adhere to study requirements
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bezmialem Vakıf University Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.