Phenotyping of Patients With Polycystic Ovary Syndrome
ConditionPolycystic Ovary Syndrome (PCOS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-49
SponsorUniversity Hospital, Strasbourg, France
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Final diagnosis excluding PCOS.
Trial 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.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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%.
Time frame
Up to 12 months2
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
Time frame
Up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov