NCT07146815

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
Last Updated

August 28, 2025

Status Verified

July 1, 2025

Enrollment Period

2.3 years

First QC Date

July 29, 2025

Last Update Submit

August 25, 2025

Conditions

NAFLD (Nonalcoholic Fatty Liver Disease)Polycystic Ovarian Syndrome (PCOS)

Outcome Measures

Primary Outcomes (2)

  • Prevalence of NAFLD

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

    Baseline and at follow-up 1 year later.

  • Prevalence of NAFLD in PCOS

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

    Baseline

Study Arms (2)

PCOS group

OTHER

Screening of women with PCOS

Diagnostic Test: FibroScanDiagnostic Test: MRI PDFF

Control group

OTHER

Screening of women without PCOS

Diagnostic Test: FibroScanDiagnostic Test: MRI PDFF

Interventions

FibroScanDIAGNOSTIC_TEST

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

Control groupPCOS group
MRI PDFFDIAGNOSTIC_TEST

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

Control groupPCOS group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseasePolycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 28, 2025

Study Start

November 29, 2022

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

August 28, 2025

Record last verified: 2025-07

Locations

BE(1)