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临床试验/NCT04109846
NCT04109846招募中不适用

Transfer of Aneuploid or Mosaic Embryos Following Preimplantation Genetic Testing

Stanford University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年4月11日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
Pregnancy Rate

研究概览

简要总结

To determine how often embryos reported to be abnormal by preimplantation genetic testing result in liveborn infants. To evaluate whether the pregnancies that result from these embryos are higher risk for complications and whether the resulting babies have higher risk for health or developmental issues in the first five years after birth.

详细描述

Genetic testing modality and results will be recorded

Pregnancy per transfer will be recorded

Patients in the study agree to provide medical records of their pregnancy.

Any genetic testing or fetal testing will be carefully reviewed and recorded by the study team.

For patients with live births, pediatric records will be collected for up to 5 years.

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
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Available aneuploid or mosaic embryos
  • No other acceptable embryos available
  • Willing to travel to Stanford for treatment
  • English language fluency

排除标准

  • Use of international donor eggs or sperm not tested according to FDA guidelines.
  • Living outside the United States
  • Embryos with Triploidy are not eligible for transfer in this protocol

研究组 & 干预措施

Non-euploid Transfer

Experimental

Patients desiring pregnancy who have no acceptable euploid embryos available for transfer who chose to undergo embryo transfer of a non-euploid embryo (either aneuploid or mosaic).

干预措施: Non-euploid embryo transfer (Other)

Euploid Transfer

Active Comparator

Patients desiring pregnancy who are undergoing euploid embryo transfer

干预措施: Euploid Transfer (Other)

结局指标

主要结局

Pregnancy Rate

时间窗: 3 years

Number participants who undergo embryo transfers that lead to a positive pregnancy test

次要结局

  • Live birth rate(4 years)
  • Obstetric complications(4 years)
  • Pediatric Development(7 years 3 months)

研究者

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

Ruth Bunker Lathi

Professor

Stanford University

研究点 (2)

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