Construction of a Multi-dimensional Risk Assessment System: a Clinical Study of Polycystic Ovary Syndrome Complicated With Thrombophilia
Recruiting · NCT07571096 · Observational (researchers observe without assigning treatment) · Lead sponsor: Guangdong Women and Children Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
14 Years to 45 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
1 location listed.
- Guangdong Women and Children Hospital - Guangzhou, Guangdong, China