Construction of a Multi-dimensional Risk Assessment System: a Clinical Study of Polycystic Ovary Syndrome Complicated With Thrombophilia

Recruiting now

Conditions studied: Polycystic Ovary Syndrome (PCOS), Thrombophilia

In brief

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.

Key facts

Study ID

NCT07571096

Run by

Guangdong Women and Children Hospital

People needed

100

Starts

2025-03-04

Expected to finish

2027-03-17

Last updated by the study team

2026-07-30

Who can join

Age: 14 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Irregular menstrual cycles are defined as follows: more than 1 year and less than 3 years after menarche, menstrual cycles shorter than 21 days or longer than 45 days; more than 3 years after menarche to perimenopause, menstrual cycles shorter than 21 days or longer than 35 days, or fewer than 8 cycles per year; any cycle longer than 90 days more than 1 year after menarche; or primary amenorrhea by age 15 years or more than 3 years after thelarche
• No use within 3 months before blood sampling of anticoagulant drugs, procoagulant drugs, oral contraceptives, or other medications that may affect sex hormones, insulin, glucose metabolism, or coagulation function

You may not qualify if…

• Confirmed pregnancy
• Hematologic disease
• History of malignant tumor
• Use of medications within 12 weeks before enrollment that may interfere with study assessments
• Disorders that may cause hyperandrogenism or ovulatory dysfunction, including congenital adrenal hyperplasia, Cushing syndrome, functional hypothalamic amenorrhea, thyroid disease, hyperprolactinemia, or primary ovarian insufficiency
• Disorders that may affect protein C or protein S levels, including antiphospholipid syndrome, liver disease, or tumor-related conditions
• In adolescents, polycystic ovarian morphology alone will not be used to establish the diagnosis of PCOS

Where it is running

• Guangdong Women and Children Hospital — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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