Thrombotic Profile of Ovarian Stimulation Protocols in Reproductive Medical Assistance: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Change in normalized APC sensitivity ratio
研究概览
简要总结
The aim of this study is to assess the impact of different protocols used for ovarian stimulation during in vitro fertilization procedures (IVF) on prothrombotic biomarkers (blood coagulation markers associated with thromboembolic events) in the units of reproductive medicine in two university hospitals (HUG, Geneva and CHUV, Lausanne).
详细描述
HEMO-STIM is a prospective multicentric cohort study of subfertile women undergoing ART. It is an epidemiologic observational study. All women older than 18 years attending the reproductive medicine unit (UMREG, Geneva, HUG or UMR, Lausanne, CHUV) and undergoing an IVF have been and will be recruited consecutively and included. The type of stimulation protocol used is recorded.
All measurements (specific haemostasis test with a thrombin generation assay before and after adjunction of APC) that are part of the study will be performed in the HUG laboratories in order to limit inter-dosage variability.
The 1st blood test will be performed at inclusion in the absence of any hormonal treatment (T1). A 2nd blood test will be performed on the day of ovulation triggering (T2). A 3rd blood test will be performed 7 days after ovulation triggering (T3).
The comparison of different protocols has never been performed and data on the effect of antagonist protocols for IVF on haemostasis are lacking. The measurement of intermediate biomarkers of thromboembolic risk during different IVF stimulation protocols (agonists and antagonists) would allow the comparison of their thrombotic profile and to optimize the risk/benefit ratio during ART by prescribing protocols at lower vascular risk, in particular in women identified as being at risk for thromboembolic events.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 43 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women older than 18 years
- •Sub-fertile and undergoing IVF
排除标准
- •>43 years old
结局指标
主要结局
Change in normalized APC sensitivity ratio
时间窗: T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation
Haemostasis parameters: thrombin Generation Assay
次要结局
- Change in fibrinolysis assay(T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation)
研究者
Casini Alessandro
Principal Investigator
University Hospital, Geneva
