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Recruiting NCT07339930

Phenotyping of Patients With Polycystic Ovary Syndrome

Observational Polycystic Ovary Syndrome (PCOS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Polycystic Ovary Syndrome (PCOS). Basic parameters: 18 years — 49 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Prevalence of obesity [Time frame: Up to 12 months]
  • Biological Indicators of Insulin Resistance [Time frame: Up to 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • ervice d'Endocrinologie, Diabétologie et Nutrition - CHU de Strasbourg - France — Strasbourg

Identifiers

NCT: NCT07339930 · 9772

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗