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临床试验/NCT01397487
NCT01397487Unknown早期 1 期

Effects of the Blastomere Biopsy of Day 3 Human Embryos on Blastocyst Percentage, Cell Number of Obtained Blastocyst and Implantation Rate

Fundacion Para La Investigacion Hospital La Fe2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2011年7月1日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
发起方
入组人数
22
试验地点
2
主要终点
Blastocyst percentage

研究概览

简要总结

The aim of this study to evaluate the effect of embryo biopsy on blastocyst development and implantation rate.

详细描述

Preimplantation genetic diagnosis (PGD) was initially developed to prevent monogenic diseases. However, its use has been extended to improve pregnancy rates in assisted reproductive techniques (ART). These new indications has been called screening for aneuploidy (PGS, preimplantation genetic screening). The current indications for PGS include advanced maternal age, recurrent miscarriage, repeated implantation failure, severe male factor infertility, previous aneuploid pregnancy, poor embryo quality, chemotherapy and radiotherapy and elective single embryo transfer to avoid multiple pregnancies. Nevertheless, the results obtained in the last decade have failed to clearly demonstrate any benefit of PGS in these indications and there are no studies evaluating the effect that biopsy could produce on embryos.

Markers of embryo quality are still very limited and are based on subjective morphological parameters (such as cell number, size and degree of fragmentation) or on the study of embryonic development by measuring the percentage of embryos reaching the blastocyst stage after 120 hours of in vitro culture. Counting the cell number of blastocysts involves the staining and subsequent nuclei counting, which is incompatible with later embryo transfer. A valid alternative to avoid nuclear staining would be a morphometric study using optical sections of different focal planes of the blastocyst and three dimensional (3D) virtual reconstructions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • No relevant medical history.
  • Age < 35 years old.
  • Unexplained infertility, tubal or male cause of infertility.
  • Between 6 and 8 embryos on day 3 of embryo culture.

排除标准

  • 未提供

研究组 & 干预措施

one single arm

Other

All patients are included to complete a biopsy of half part of the embryos

干预措施: Blastomere biopsy (Procedure)

结局指标

主要结局

Blastocyst percentage

时间窗: after 120 hours of culture

次要结局

  • Number of cells of blastocyst measured by morphometric analysis(after 120 hours of culture)
  • Implantation rate(after one month of embryo transfer.)

研究者

发起方
Fundacion Para La Investigacion Hospital La Fe
申办方类型
Other

研究点 (2)

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