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临床试验/NCT02407730
NCT02407730已完成不适用

EFFects of Thrombophilia on the Outcomes of Assisted Reproduction

G. d'Annunzio University1 个研究点 分布在 1 个国家目标入组 687 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
687
试验地点
1
主要终点
Live birth rate

研究概览

简要总结

Both hereditary and acquired thrombophilia have been associated with recurrent miscarriage and pregnancy complications. Thrombophilia could favor the development of thrombosis of the maternal vasculature and obstacle placentation. Some studies have suggested a role of thrombophilia in the failure of assisted reproductive techniques although this association has been recently questioned. The scope of this study is to evaluate the effect of thrombophilia on the implantation rate and live birth rate in women undergoing ART.

Design: prospective, observational study Primary end-point: live birth rate. Secondary end-points: implantation rate, venous thromboembolic events during ART up to 6 weeks post-partum

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women undergoing ART
  • age 18 years or older

排除标准

  • ongoing anticoagulant therapy
  • previous venous thromboembolism
  • no informed consent

结局指标

主要结局

Live birth rate

时间窗: Participants will be followed for the duration of the pregnancy, an expected average of 9 months

次要结局

  • implantation rate(Participants will be followed from the implantation to the ultrasonography to document the gestational sac, an expected average of 7 weeks)

研究者

发起方
G. d'Annunzio University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcello Di Nisio

Principal Investigator

G. d'Annunzio University

研究点 (1)

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