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Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study - Trial NCT06339567

Access comprehensive clinical trial information for NCT06339567 through Pure Global AI's free database. This phase not specified trial is sponsored by Fondation Hรดpital Saint-Joseph and is currently Recruiting. The study focuses on Polycystic Ovary Syndrome. Target enrollment is 320 participants.

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NCT06339567
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diagnostic test
Trial Details
ClinicalTrials.gov โ€ข NCT06339567
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Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study

Study Focus

Polycystic Ovary Syndrome

Thrombotic profile

Interventional

diagnostic test

Sponsor & Location

Fondation Hรดpital Saint-Joseph

Paris, France

Timeline & Enrollment

N/A

Feb 08, 2024

Feb 07, 2029

320 participants

Primary Outcome

biological procoagulant profile

Summary

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of women of
 childbearing age. PCOS can be individualized into several phenotypes, taking into account in
 particular the presence of hyperandrogenism, insulin resistance and BMI. Hyperandrogenism and
 insulin resistance appear to be important factors in the development of cardiovascular
 cardiovascular disease. In addition, patients frequently use anti-androgenic and/or
 contraceptive treatments contraceptives, such as combined hormonal contraception (CHC), the
 use of which is associated with an increased cardiovascular and thrombo and venous thrombosis
 (VTE). A meta-analysis published in 2020 by Gariani et al.
 
 based on three large studies, estimated the risk of VTE in women with PCOS after adjustment
 for obesity and hormone therapy. This risk was significantly higher compared with women
 without PCOS (pooled OR 1.89, CI95% 1.60-2.24). No study has looked specifically investigated
 the risk of VTE according to different PCOS phenotypes. Such data would be very useful in
 clinical practice, as it would enable monitoring, contraceptive treatment and anti-androgenic
 anti-androgen treatment according to the PCOS phenotype, while limiting risks. Assessing the
 differences PCOS phenotypes is limited by the large sample size required. required. VTE is a
 rare event in women of childbearing age, and the number of PCOS phenotypes is high.
 
 PCOS phenotypes. Intermediate markers of VTE risk are used in these situations. These markers
 are thrombin generation tests (notably ETP) and their sensitivity to activated protein C
 (nAPCsr) and thrombomodulin (nTMsr), as well as sex-hormone binding globulin (SHBG).

ICD-10 Classifications

Polycystic ovarian syndrome
Ovarian dysfunction, unspecified
Ovarian dysfunction
Other ovarian dysfunction
Neoplasm of uncertain or unknown behaviour: Ovary

Data Source

ClinicalTrials.gov

NCT06339567

Non-Device Trial