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NCT Number: NCT07339930

Phenotyping of Patients With Polycystic Ovary Syndrome

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.

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ervice d'Endocrinologie, Diabétologie et Nutrition - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Ombeline VILLETTE, MD

PRINCIPAL_INVESTIGATOR

Thibault BAHOUGNE, MD

CONTACT

[email protected]

33 3.88.12.78.99

Thibault BAHOUGNE, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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%.

  2. Biological Indicators of Insulin Resistance

    Time frame: Up to 12 months

    Biological Indicators of Insulin Resistance:

    • 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
    • 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

    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Thibault BAHOUGNE, MD

CONTACT

[email protected]

33 3.88.12.78.99

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: SOPK

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

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.

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