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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thrombotic profil | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombotic profile | Diagnostic Test | several thrombotic biological marker will be dosed in blood. (C protein, S protein, CRP us, Factor VIII, TFPI , nAPCsr, SHBG, nTMsr) |
|
| Measure | Description | Time Frame |
|---|---|---|
| biological procoagulant profile | Evaluation of the biological procoagulant profile in women of childbearing age with PCOS, in relation to the presence or absence of insulin resistance, by comparing FTE levels between women with PCOS and women without PCOS. the presence or absence of insulin resistance, by comparing ETP levels between women with PCOS without and with insulin resistance | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Insuline resistance and weight | Estimate the prevalence of overweight, obesity, and insulin resistance in women with with PCOS | 1 year |
| comparison of procoagulant profile depending on insulin resistance |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Paris Saint Joseph | Paris | France | France |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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comparison of procoagulant biomarker for women with or without insulin resistance
| 1 year |
| comparison of procoagulant profile depending on hyperangrogenism | comparison of procoagulant biomarker for women with or without hyperangrogenism | 1 year |
| comparison of procoagulant profile depending on PCOS phenotype | comparison of procoagulant biomarker depending on PCOS phenotype | 1 year |
| comparison of procoagulant profile depending on AMH Rate | comparison of procoagulant biomarker depending on AMH Rate | 1 year |
| comparison of QoL score depending on PCOS phenotype | comparison of PCOS-QoL, SF36 and HADS scores depending on PCOS phenotype | 1 year |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |