Clinical trial NCT06339567: Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study
Official title: Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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).


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).

Primary outcomes:
measure: biological procoagulant profile
timeFrame: one year
Secondary outcomes:
measure: Insuline resistance and weight
timeFrame: 1 year
measure: comparison of procoagulant profile depending on insulin resistance
timeFrame: 1 year
measure: comparison of procoagulant profile depending on hyperangrogenism
timeFrame: 1 year
measure: comparison of procoagulant profile depending on PCOS phenotype
timeFrame: 1 year
measure: comparison of procoagulant profile depending on AMH Rate
timeFrame: 1 year
measure: comparison of QoL score depending on PCOS phenotype
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Paris Saint Joseph
Study officials:
References: