NCT06339567

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

Fondation Hôpital Saint-Joseph·ClinicalTrials.gov·diagnostic testRecruiting
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Study focus
Disease/Condition
Polycystic Ovary Syndrome
Drug/Device/Intervention
Thrombotic profile
Study type
Interventional
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
Fondation Hôpital Saint-Joseph
Location
Paris, France
Timeline & enrollment
Phase
N/A
Start date
Feb 08, 2024
End date
Feb 07, 2029
Enrollment
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 syndromeOvarian dysfunction, unspecifiedOvarian dysfunctionOther ovarian dysfunctionNeoplasm of uncertain or unknown behaviour: Ovary
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06339567
Type
Non-Device Trial
About this record

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

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