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临床试验/NCT04496284
NCT04496284已完成不适用

Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen

Reproductive Medicine Associates of New Jersey2 个研究点 分布在 1 个国家目标入组 253 人开始时间: 2020年9月5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
253
试验地点
2
主要终点
sustained implantation rate

研究概览

简要总结

The proposed study is a single-blind randomized controlled trial which seeks to characterize implantation rates following embryo vitrification and subsequent warming with both slush nitrogen and liquid nitrogen. After warming, implantation rates and pregnancy outcomes will be assessed.

详细描述

The purpose of this study is to determine if slush nitrogen for embryo vitrification results in higher sustained implantation rates compared to the conventional use of liquid nitrogen. Routine ovarian stimulation, oocyte retrieval and embryology care will ensue. All blastocyst stage embryos will be randomized to either the control (liquid nitrogen) or intervention group (slush nitrogen) and vitrified after trophectoderm biopsy has been performed for PGT-A (preimplantation genetic testing for aneuploidy). A single, chromosomally normal embryo will be transferred in a subsequent frozen embryo transfer cycle per routine. Implantation rates and pregnancy outcomes will be assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

sustained implantation rate

时间窗: approximately 8 weeks gestation age

fetal heart beat present upon discharge at 8 weeks

次要结局

  • clinical pregnancy rate(usually by 5 weeks gestational age)
  • miscarriage rate(1-8 months dependent on gestational age of loss)
  • live birth rate(9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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