PolyCystic Ovary Syndrome as Suggested Risk Group for Non-Alcoholic Fatty Liver Disease

To study the prevalence, non-invasive diagnostics and evolution of non-alcoholic-fatty-liver-disease (NAFLD) in patients with polycystic ovary syndrome (PCOS)

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Key information

Conditions

NAFLD (Nonalcoholic Fatty Liver Disease) Adnexal Diseases Cysts Digestive System Diseases Endocrine System Diseases Fatty Liver Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Liver Diseases Neoplasms Non-alcoholic Fatty Liver Disease Ovarian Cysts Ovarian Diseases Polycystic Ovarian Syndrome (PCOS) Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults (i.e. older than 18 years of age)
The diagnosis of PCOS based on expert opinion (i.e. according to Rotterdam criteria)
Able to understand patients information concerning this study
Able to give written informed consent

Exclusion criteria

Excessive alcohol use: ≥ 2u (20g)/day for females
Exclusion of other causes of liver disease
Secondary causes of liver steatosis
Other causes of endocrinological disease
Diseases that might mimic PCOS

Treatment and study plan

FibroScan

Diagnostic Test

Performance of a FibroScan measurement to determine the prevalence of liver steatosis.

MRI PDFF

Diagnostic Test

Performance of an MRI-PDFF to determine amount of liver steatosis.

Primary outcomes

Prevalence of NAFLD

Time frame: Baseline and at follow-up 1 year later.

To study the prevalence of NAFLD in a population diagnosed with PCOS measured with Controlled Attenuation Parameter (CAP)
Prevalence of NAFLD in PCOS

Time frame: Baseline

To measure the prevalence of NAFLD in women with PCOS using the MRI-PDFF technique.

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Registry information

Acronym: P-CORIGA

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Aug 28, 2025
Registry last updated: Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed