Phenotyping of Patients With Polycystic Ovary Syndrome (SOPK)

January 5, 2026 updated by: University Hospital, Strasbourg, France

Phenotyping of Patients With Polycystic Ovary Syndrome (PCOS) in Alsace, France

Polycystic ovary syndrome (PCOS) is the leading endocrine disorder of the reproductive system, affecting 10 to 13% of women of childbearing age. However, there is a significant delay in diagnosis, which may be due to considerable clinical heterogeneity and a lack of information among the general population. The diagnosis is made when two of the three Rotterdam criteria established in 2003 and revised in 2023 are met, namely: 1) menstrual cycle disorders (oligoanovulation) - 2) clinical or biological hyperandrogenism - 3) OPK morphological appearance or elevated anti-Müllerian hormone (AMH) levels, after exclusion of differential diagnoses. PCOS is a condition that carries a risk of metabolic complications and fertility problems due to dysovulation. Patients have an impaired quality of life and are at greater risk of anxiety and depression, which should be screened for systematically.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • ervice d'Endocrinologie, Diabétologie et Nutrition - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Thibault BAHOUGNE, MD
        • Principal Investigator:
          • Ombeline VILLETTE, MD

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

No

Sampling Method

Non-Probability Sample

Study Population

Adult woman (≥18 years and <50 years) who consulted at the Strasbourg University Hospitals for suspected PCOS or for any other endocrinological condition that led to the discovery of PCOS.

Description

Inclusion Criteria:

  • Adult woman (≥18 years and <50 years)
  • Subject who consulted at the Strasbourg University Hospitals for suspected PCOS or for any other endocrinological condition that led to the discovery of PCOS.

Exclusion Criteria:

  • Final diagnosis excluding PCOS.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of obesity
Time Frame: Up to 12 months

The prevalence of obesity indicates the proportion of obese individuals in a population (a country, a region, a school, etc.) at a given time.

It is often expressed as a percentage.

Example:

If, in a region of 1,000 inhabitants, 200 people are obese,

→ the prevalence of obesity is 20%.
Up to 12 months
Biological Indicators of Insulin Resistance
Time Frame: Up to 12 months

Biological Indicators of Insulin Resistance:

  1. Fasting Blood Glucose (Blood Sugar) Measured after 8-12 hours of fasting. Normal: ~0.70 to 1.00 g/L (3.9-5.6 mmol/L) Abnormal: ≥1.00 g/L may suggest a disorder

  2. Fasting Insulin Indicates how much insulin the body produces at rest.

    Normal (approx.): 2 to 10 µIU/mL High: > 10-12 µIU/mL → suspected insulin resistance

  3. HOMA-IR Index (most commonly used)

Calculated with:

fasting blood glucose × fasting insulin ÷ 22.5 (in mmol/L)

Common interpretation:

< 2: normal insulin sensitivity 2-2.9: possible insulin resistance

≥ 3: probable insulin resistance
Up to 12 months

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

September 17, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 17, 2026

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9772

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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