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临床试验/NCT04188444
NCT04188444已完成不适用

Thrombotic Profile of Ovarian Stimulation Protocols in Reproductive Medical Assistance: a Prospective Cohort Study

University Hospital, Geneva2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2017年3月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Casini Alessandro

Principal Investigator

University Hospital, Geneva

研究点 (2)

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