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临床试验/NCT03833869
NCT03833869Unknown不适用

The Effect of Assisted Hatching on Implantation Rate in Frozen Blastocyst Transfer - a Prospective Randomized Controlled Study

Wolfson Medical Center1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2019年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
84
试验地点
1
主要终点
Implantation rate

研究概览

简要总结

The current study aims to assess the effect of assisted hatching on the implantation rate of frozen blastocytes.

详细描述

The Zona Pellucida protects the ovum from the penetration of multiple sperm, and from mechanical and physiological damage until the fertilized ovum reaches the uterus. Subsequently, spontaneous hatching occurs, and enables the embryo to attach to the endometrium. The technique of assisted hatching was originally investigated as a means to improve implantation in cases of zona hardening, and is commonly performed in 3-day embryos. In the current study, the investigators aim to investigate the effect of assisted hatching on 5-day frozen embryos.

研究设计

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

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • In-vitro fertilization patients at the investigators' institution, intended to undergo a transfer of a frozen five-day embryo (blastocyte)
  • 18 to 39 years old
  • First to third treatment cycle
  • Patient has previously had a maximum of four embryos transferred.

排除标准

  • Over 40 years old
  • Congenital or acquired uterine malformations
  • Hydrosalpinx
  • Chronic autoimmune diseases
  • Embryo intended to be undergo preimplantation genetic diagnosis

研究组 & 干预措施

Assisted hatching

Experimental

Five-day frozen embryos will undergo assisted hatching prior to embryo transfer

干预措施: Assisted hatching (Procedure)

Control

No Intervention

Five-day frozen embryos will not undergo any additional procedures prior to embryo transfer

结局指标

主要结局

Implantation rate

时间窗: Five to six weeks following embryo transfer

Number of gestational sacs demonstrated on ultrasound divided by the number of embryos transferred (expressed as percentage)

次要结局

  • Early spontaneous abortion(Up to 15 weeks from embryo transfer)
  • Chemical pregnancy(Five to six weeks following embryo transfer)

研究者

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

Hadas Ganer Herman

Principal Investigator

Wolfson Medical Center

研究点 (1)

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