Risk tool for blood-clotting problems in adolescents and women with PCOS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Guangdong Women and Children Hospital
  Guangzhou, Guangdong, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Polycystic Ovary Syndrome in Type 1 Diabetes

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• DOACs versus VKAs to prevent repeat clots in low‑risk antiphospholipid syndrome

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  Recruiting at 2 sites Infanta Leonor University Hospital · Madrid, Madrid and 1 other locations · NCT07372170

• Detailed health profiling for people with PCOS

  This effort will collect clinical, hormonal (including AMH), and imaging information from adult women seen at Strasbourg University Hospital with suspected or confirmed PCOS to try to better define PCOS types.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.