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临床试验/NCT01950104
NCT01950104撤回不适用

Comparative Study Between Day 3 Embryo Biopsy and Blastocyst Biopsy in Preimplantation Genetic Screening Cases

IVI Sevilla2 个研究点 分布在 1 个国家开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Live birth rate

研究概览

简要总结

Preimplantation genetic diagnosis (PGS) is a technique that allow us to improve the results of assisted reproduction techniques through the selection of embryos free of chromosomal abnormalities.

At present, it has not been proved that the usage of PGS really improves the live birth rate in IVF cycles. However, it has been stated that the reason of not having better results when using PGS is that the methodology applied is not adequate.

Several authors propose that the optimal methodology for PGS includes the application of comparative genomic hybridization (CGH) arrays for genetic testing and carrying out embryo biopsy at the blastocyst stage. Nevertheless, most IVF centres still applies the day 3 embryo biopsy as a daily routine. Despite this fact, there is a gradual transition towards the usage of blastocyst-stage biopsy instead of day 3 biopsy.

The purpose of this clinical study is analysing the results of the IVF cycles with embryo biopsy for PGS. Live birth rates and other parameters as the pregnancy and implantation rates together with embryo quality will be analysed and compared between two groups of patients undergoing IVF cycles with PGS. In one group the biopsy will be applied in day 3 of the embryo development, while in the other group the embryo biopsy will be fulfilled at the blastocyst stage.

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
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients under 49 years undergoing IVF cycles with PGS for one of the following reasons:
  • Advanced maternal age
  • Recurrent implantation failure
  • Recurrent abortion
  • Severe male-factor infertility

排除标准

  • Not being able to sign the informed consent to participate in the study
  • Patients undergoing preimplantation genetic diagnosis

结局指标

主要结局

Live birth rate

时间窗: 20 months

次要结局

  • Fertilization rate(1 year)
  • Embryo quality(1 year)
  • Implantation rate(1 year)
  • Pregnancy rate(20 months)

研究者

发起方
IVI Sevilla
申办方类型
Other
责任方
Sponsor

研究点 (2)

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