Phenotyping of Patients With Polycystic Ovary Syndrome (PCOS) in Alsace, France
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Prevalence of obesity
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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%.
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
Secondary Outcomes
No secondary outcomes reported