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Phenotyping of Patients With Polycystic Ovary Syndrome

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07339930
Acronym
SOPK
Enrollment
100
Registered
2026-01-14
Start date
2025-09-17
Completion date
2026-09-17
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

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

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.

Interventions

None listed

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of obesityUp to 12 monthsThe 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%.
Biological Indicators of Insulin ResistanceUp to 12 monthsBiological 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

Countries

France

Contacts

Primary ContactThibault BAHOUGNE, MD
thibault.bahougne@chru-strasbourg.fr33 3.88.12.78.99

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026