Phenotyping of Patients With Polycystic Ovary Syndrome

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Prevalence of obesity — 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 — 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

Trial sites (1)

More University Hospital, Strasbourg, France trials in France

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