NCT07571096Recruiting
Construction of a Multi-dimensional Risk Assessment System: a Clinical Study of Polycystic Ovary Syndrome Complicated With Thrombophilia
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 30 Apr 2026
- Start date
- 4 Mar 2025
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- Guangdong Women and Children Hospital
- NCT number
- NCT07571096
What you commit to
- Study type: Observational
- Planned participants: 100
- From 4 Mar 2025 to the primary completion date, 1 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of medications within 12 weeks before enrollment that may interfere with study assessments
Other illness
- Hematologic disease
- History of malignant tumor
- 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
Other
- Confirmed pregnancy
- In adolescents, polycystic ovarian morphology alone will not be used to establish the diagnosis of PCOS
Who the study is looking for
- 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
Age in the registry: 14 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangdong Women and Children Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.