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临床试验/NCT03157765
NCT03157765撤回不适用

A Randomized Study on the Value of an Endometrial Scratch Prior to a Frozen Embryo Transfer Cycle in the Treatment of Recurrent Implantation Failure

Brown Fertility0 个研究点开始时间: 2017年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
clinical pregnancy rate

研究概览

简要总结

Patients with a history of recurrent implantation failure who are planning a frozen embryo transfer (FET) are enrolled into the program. Patients are randomized to an endometrial biopsy prior to starting estrogen to prepare for the transfer of warmed vitrified embryos or to routine care.

详细描述

Patients who failed to achieve a clinical pregnancy after embryo transfer of at least three high quality embryos in at least two IVF or FET cycles and for whom their last failed cycle was a frozen embryo transfer are offered the opportunity to enroll in this study. All patients will follow our routine FET protocol.

On a randomized basis, selected patients will undergo an endometrial biopsy using a Pipelle disposable device in the week prior to starting estrogen to prepare her endometrium.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •At least two prior consecutive failed IVF or FET cycles with transfer of at least 3 high quality embryos and with last cycle a FET cycle

排除标准

  • •Alternate explanation for implantation failure (e.g., intrauterine pathology)

研究组 & 干预措施

EMB intervention

Experimental

These patients receive and endometrial biopsy

干预措施: endometrial biopsy (Procedure)

Routine care

No Intervention

These patient receive routine care

结局指标

主要结局

clinical pregnancy rate

时间窗: within 6 months after recruitment

Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers

Implantation rate

时间窗: within 6 months after recruitment

Sacs seen in early ultrasound divided by the number of embryos transferred

次要结局

  • ongoing pregnancy rate(within 18 months of recruitment)
  • biochemical pregnancy rate(within 6 months after recruitment)
  • miscarriage rate(within 18 months after recruitment)

研究者

发起方
Brown Fertility
申办方类型
Other
责任方
Sponsor

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