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临床试验/NCT03810157
NCT03810157Unknown不适用

Does Laser-assisted Hatching(LAH) May Improve the Pregnancy Outcomes in Human?

Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2018年12月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
1,200
试验地点
1
主要终点
Efficacy of LAH in ART

研究概览

简要总结

A defect in the hatching stage is considered an important cause of implantation failure. Therefore, assisted hatching (AH), which involves artificial disruption of the zona pellucida, has been proposed as a method for improving the capacity of the embryo to implant. But the advantage of using laser to facilitate the hatching process of embryos in ART practice is debatable, and an optimum strategy for performing LAH remains elusive. Therefore, the aim of this study was to evaluate the effects of laser-assisted hatching(LAH) on clinical outcomes. Patients were randomly divided into control and LAH groups. The zona pellucida was thinned or drilled with a diode laser. Relevant parameters are recorded to evaluate the validity of LAH in ART.

详细描述

Hatching is a very important process for successful implantation involving the breaking of the embryo out of the zona pellucida at the blastocyst stage. Inadequate hatching of the blastocyst might lead to implantation failure in ART. Currently, a variety of AH techniques have been used including zona thinning and the opening or complete removal of the zona by laser. But the advantage of using laser to facilitate the hatching process of embryos in ART practice is debatable, and an optimum strategy for performing LAH remains elusive. Therefore, the investigator aim to discuss the effectiveness of LAH in ART.

In this study, patients were randomly divided into control and LAH groups. A quarter of zona pellucida of the cleavage-stage embryo was thinned to 6.6 μm. All operation was performed in the empty region without contact to the blastomere in order to minimize the blastomere damage. The ZP of blastocyst was drilled with laser, the ZP opening 20% of its initial length. The operation was performed in the opposite region of ICM in order to minimize the damage. In the control group, embryos were transplanted without LAH. The rate of clinical pregnancy, live-birth, miscarriage, multiple gestation were evaluated. This research intends to discuss whether LAH can improve the clinical outcomes in ART, and further choice the appropriate LAH action site.

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
Single (Participant)

入排标准

年龄范围
22 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients undergoing IVF/ICSI-ET cycle;
  • The zone pellucida of the cleavage-stage embryo is thicker than 8 μm.

排除标准

  • Number of embryos transferred per cycle >2;
  • The transferred embryos including fresh and frozen cycle in the same cycle;
  • Embryos developed from the frozen-thawed oocytes.

研究组 & 干预措施

Laser-assisted hatching system

Experimental

Embryos were exposed to a dose of laser energy focused outside the zona pellucida by aser-assisted hatching system.

干预措施: Laser-assisted hatching system (Device)

Control group

No Intervention

Nothing is done.

结局指标

主要结局

Efficacy of LAH in ART

时间窗: 6 months

Assess the clinical pregnancy

次要结局

  • Feasibility of LAH in ART(1 year)

研究者

发起方
Tang-Du Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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