Phenotyping of Patients With Polycystic Ovary Syndrome

NCT07339930 | Recruiting

• 1 other identifier: 9772
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

Polycystic ovary syndrome (PCOS); Polycystic Ovary; Endocrine disorder; Menstrual cycle disorders; Anti-Müllerian hormone (AMH)

Outcome Measures

Primary Outcomes (2)

• Prevalence of obesity

  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

  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

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Final diagnosis excluding PCOS.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Endocrine System Diseases

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders

Central Study Contacts

Thibault BAHOUGNE, MD

CONTACT

33 3.88.12.78.99; thibault.bahougne@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 14, 2026
• Study Start: September 17, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 17, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

FR (1)