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临床试验/NCT02915276
NCT02915276Unknown早期 1 期

Comparison of Genomic DNA Analysis Between Blastocoele Fluid and Trophectoderm Biopsy in Human Embryos

Center for Reproductive an Genetic Health2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
早期 1 期
发起方
入组人数
250
试验地点
2
主要终点
Number of blastocyst with genomic DNA present in the blastocoelic cavity

研究概览

简要总结

For the purpose of this study, the investigators will perform the removal of trophectoderm (TE) the cells as required for the purpose of pre-implantation genetic screening, in order to perform the genetic analysis. Additionally, the investigators will remove the blastocoelic fluid (BF) and perform additional genetic analysis on the embryo in order to determine the agreement of the genetics results between TE cells and BF.

详细描述

The human embryo (fertilised egg) develops from a single cell and goes through several developmental stages in order to prepare for implantation inside the womb. During the fifth and sixth day post fertilisation, the embryo becomes a blastocyst. It consists of 100-150 cells and has two cell types. The inner cell mass (ICM) will give rise to the baby and the trophectoderm cells will become the placenta. The trophectoderm (TE) cells surround the ICM. Following the formation of the two cell types, the TE cells start producing fluid. The progressive accumulation of fluid leads to the formation of a cavity that expands to form the blastocele cavity. This cavity contains fluid is known as blastocoelic fluid (BF). The fluid can contain proteins, cells and genetic material. Traditionally to make a genetic diagnosis or when to screen embryos for abnormal chromosome number, cells are removed (biopsy) from the trophectoderm. In experienced hands, this is a very safe procedure and causes minimal damage to the embryo. However, recent studies have shown that blastocoele fluid may contain genetic material which can be aspirated (drawn out) from the blastocole cavity (blastocentesis) and used for genetic analysis of an embryo. This is potentially less invasive and harmful to the embryo. The aim of this study is to compare genetic analysis obtained following blastocentesis versus trophectoderm cell biopsy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Couples undergoing assisted reproduction for pre-implantation genetic diagnosis

排除标准

  • Any other couples undergoing assisted reproduction

结局指标

主要结局

Number of blastocyst with genomic DNA present in the blastocoelic cavity

时间窗: Twelve months

次要结局

未报告次要终点

研究者

发起方
Center for Reproductive an Genetic Health
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Kalliopi Loutradi

Deputy Head of Embryology

Center for Reproductive an Genetic Health

研究点 (2)

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