Evaluating blood clot risks in different types of PCOS
Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study
This study is testing how different types of Polycystic Ovary Syndrome (PCOS) affect the risk of blood clots in women aged 18 to 35.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Fondation Hôpital Saint-Joseph Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06339567 on ClinicalTrials.gov |
What this trial studies
This study investigates the venous thrombotic biological profile associated with various phenotypes of Polycystic Ovary Syndrome (PCOS) in women aged 18 to 35. It aims to understand how factors like hyperandrogenism and insulin resistance contribute to the risk of cardiovascular diseases and venous thromboembolism (VTE) in these patients. Participants must have ceased hormonal contraception or insulin-sensitizing treatments for at least three months prior to inclusion. The study will analyze the thrombotic profiles of these women to identify potential risks linked to their specific PCOS phenotype.
Who should consider this trial
Good fit: Ideal candidates are French-speaking women aged 18 to 35 with a strong suspicion of PCOS who have not used hormonal contraception or insulin-sensitizing treatments for at least three months.
Not a fit: Patients who are currently pregnant, breastfeeding, or have a history of venous thromboembolism or thrombophilia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better risk assessment and management strategies for women with PCOS, particularly regarding cardiovascular health.
How similar studies have performed: While studies have indicated increased VTE risks in women with PCOS, this specific investigation into different phenotypes is novel and has not been extensively explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be between 18 and 35 years of age at the time of inclusion; * Able to give non-opposition * Strong suspicion of PCOS according to 2023 recommendations * Have stopped hormonal contraception for at least 3 months or insulin-sensitizing treatment for at least 3 months. * Fasting for at least 12 hours. * Be affiliated to a health insurance scheme. * French-speaking Exclusion Criteria: * Already included in a type 1 interventional research protocol (RIPH1). * Be under guardianship or curatorship * Deprived of liberty * Under court protection * Pregnant (positive urine or blood pregnancy test), or within 3 months of post-partum or post abortum, or breastfeeding (or within 3 months of weaning) * Using hormonal contraception or insulin-sensitizing therapy (a wash-out of at least 3 months before inclusion). * Have a personal history of VTE or known thrombophilia. * Current anticoagulant or antiaggregant treatment or treatment stopped less than one month before inclusion. * Have a severe personal medical history in the previous 6 weeks (fracture, infection, hospitalization, surgery, cardiovascular event, cancer).
Where this trial is running
Paris
- Hôpital Paris Saint Joseph — Paris, France (Recruiting)
Study contacts
- Study coordinator: Justine Hugon Rodin, MD
- Email: jhugon@ghpsj.fr
- Phone: +33144127883
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.