Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- biological procoagulant profile
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Thrombotic profil
干预措施: Thrombotic profile (Diagnostic Test)
结局指标
主要结局
biological procoagulant profile
时间窗: one year
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
次要结局
- comparison of procoagulant profile depending on insulin resistance(1 year)
- comparison of procoagulant profile depending on PCOS phenotype(1 year)
- comparison of procoagulant profile depending on AMH Rate(1 year)
- comparison of QoL score depending on PCOS phenotype(1 year)
- Insuline resistance and weight(1 year)
- comparison of procoagulant profile depending on hyperangrogenism(1 year)