About this trial
This observational case-control study aims to develop a multidimensional risk assessment model for thrombophilia-related abnormalities in females with polycystic ovary syndrome (PCOS). The study will analyze endocrine, metabolic, and genetic factors associated with decreased protein C and/or protein S levels in participants with PCOS. The results are expected to provide evidence for risk stratification and individualized management in this population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female participants aged 14 to 45 years
Diagnosis of polycystic ovary syndrome (PCOS)
For adult participants, PCOS diagnosed according to the 2023 international evidence-based guideline. After exclusion of related disorders, diagnosis is based on ovulatory dysfunction and/or irregular menstrual cycles together with clinical hyperandrogenism, biochemical hyperandrogenism, or polycystic ovarian morphology on ultrasound where appropriate
For adolescent participants, PCOS diagnosed according to adolescent-specific recommendations. After exclusion of related disorders, both ovulatory dysfunction and/or irregular menstrual cycles and clinical or biochemical hyperandrogenism are required
Disqualifiers
Confirmed pregnancy
Hematologic disease
History of malignant tumor
Use of medications within 12 weeks before enrollment that may interfere with study assessments
Trial population
Female participants aged 14 to 45 years with polycystic ovary syndrome will be enrolled. Participants will be classified according to the presence or absence of decreased protein C and/or protein S levels.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Decreased protein C and/or protein S levels
Assessment of decreased protein C and/or protein S levels in women with polycystic ovary syndrome at study enrollment based on laboratory testing.
Sponsors and contacts
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