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临床试验/NCT03503877
NCT03503877已完成不适用

Aneuploidy Rates and Morphokinetic Parameters in Sibling Embryos Cultured in Distinct Culture Media

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年2月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Aneuploidy Rates

研究概览

简要总结

Embryonic aneuploidy is the underlying etiology for the majority of failed implantation and miscarriage. Preimplantation genetic screening (PGS) with transfer of a euploid embryo has been advocated as a strategy for increasing live birth rates with a single embryo transfer. Culturing embryos to the blastocyst stage for trophectoderm biopsy is a requirement for PGS. Several commercially-available single-step embryonic culture media with varying composition have been established for use in the IVF laboratory. Early reports have suggested differences in clinical outcomes, such as aneuploidy and miscarriage rates, with distinct culture media currently in standard use. However, there have been no clinical trials demonstrating the superiority of any one commercially-available culture media formulation. As a result, clinics use media with varying composition based upon familiarity and cost.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, 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
是

入选标准

  • •All subjects planning blastocyst culture for preimplantation genetic screening (PGS) will be offered enrollment.
  • •Antral Follicle Count (AFC) >8 Male and female partner > 18 years of age

排除标准

  • •Female partner age >42 years of age Cleavage stage biopsy

研究组 & 干预措施

SAGE Media

Other

SAGE single-step MEDIA

干预措施: EmbryoScope Plus (Device)

SAGE Media

Other

SAGE single-step MEDIA

干预措施: SAGE MEDIA (Other)

GLOBAL Media

Other

LIFE GLOBAL single-step MEDIA

干预措施: EmbryoScope Plus (Device)

GLOBAL Media

Other

LIFE GLOBAL single-step MEDIA

干预措施: GLOBAL MEDIA (Other)

结局指标

主要结局

Aneuploidy Rates

时间窗: Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment

number of embryos with abnormal chromosome number over total number of embryos biopsied (%)

次要结局

  • Embryo Quality(2 weeks from start of IVF treatment)
  • Embryo Morphokinetics(2 weeks from start of IVF treatment)
  • Embryonic Mosaicism(Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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