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Trial Title:
Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study
NCT ID:
NCT06339567
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Thrombotic profile
Description:
several thrombotic biological marker will be dosed in blood. (C protein, S protein, CRP
us, Factor VIII, TFPI , nAPCsr, SHBG, nTMsr)
Arm group label:
Thrombotic profil
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).
Criteria for eligibility:
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).
Gender:
Female
Minimum age:
18 Years
Maximum age:
35 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpital Paris Saint Joseph
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Juliette COURTIADE MAHLER
Email:
jcourtiade@ghpsj.fr
Contact backup:
Last name:
Hélène Beaussier, pharmaD
Email:
hbeaussier@ghpsj.fr
Start date:
February 8, 2024
Completion date:
February 7, 2029
Lead sponsor:
Agency:
Fondation Hôpital Saint-Joseph
Agency class:
Other
Source:
Fondation Hôpital Saint-Joseph
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06339567
