Risk tool for blood-clotting problems in adolescents and women with PCOS
Construction of a Multi-dimensional Risk Assessment System: a Clinical Study of Polycystic Ovary Syndrome Complicated With Thrombophilia
This project will try to build a risk model to spot decreased protein C or S and other clotting abnormalities in females aged 14–45 who have PCOS.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 14 Years to 45 Years |
| Sex | Female |
| Sponsor | Guangdong Women and Children Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07571096 on ClinicalTrials.gov |
What this trial studies
This is an observational case-control study enrolling females aged 14–45 with PCOS and classifying them by whether they have decreased protein C and/or protein S levels. Researchers will collect endocrine, metabolic, and genetic data and compare the groups using descriptive statistics, univariable tests, and multivariable logistic regression. The goal is to combine those variables into a multidimensional risk assessment model for thrombophilia-related abnormalities. Results are intended to inform risk stratification and individualized management for people with PCOS.
Who should consider this trial
Good fit: Females aged 14 to 45 years diagnosed with PCOS according to the 2023 international guideline (adults) or adolescent-specific criteria are eligible.
Not a fit: People who are outside the 14–45 age range, do not meet the PCOS diagnostic criteria, or whose clotting problems arise from causes not captured by protein C/S measurements likely would not benefit from this model.
Why it matters
Potential benefit: If successful, the model could help clinicians identify which patients with PCOS are at higher risk for clotting abnormalities and guide personalized prevention or treatment.
How similar studies have performed: Prior research has linked PCOS to increased clotting risk, but comprehensive multidimensional risk models focused on protein C and S abnormalities are novel and not yet well validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong
- Guangdong Women and Children Hospital — Guangzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.