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临床试验/NCT05216068
NCT05216068已完成不适用

Investigation and Diagnosis of the Chromosome Variation in Donated/abandoned Blastocyst

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2021年12月1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
发起方
入组人数
57
试验地点
2
主要终点
Blastocyst aneuploidy rate

研究概览

简要总结

Blastocysts derived from patients seeking infertility treatment were generated by in vitro fertilization and embryo culture as previously described, and were evaluated using the Gardner system. As part of the embryo selection process, cells of TE biopsy were collected, and blastocysts were vitrified. The clinical TE biopsies were subjected to whole genome amplification (WGA) with SurePlex reagents (Illumina) followed by NGS-based PGT-A using Illumina's VeriSeq kit (Illumina) on a MiSeq system (Illumina) according to the manufacturer's protocol.

详细描述

Collected 200 donate abandonment embryos (well-developed blastocysts) for research under the National Assisted Reproduction Act of Taiwan.

  1. Collected 200 donate abandonment embryos: Five to six days after egg retrieval, well-developed embryos (called blastocysts).
  2. Blastocysts derived from patients seeking infertility treatment were generated.
  3. Embryos biopsies for PGT-A (by use of NGS platforms from our institute) will be used for the validation of our Lab QC embryo.
  4. To standardize the operating procedures
  5. Paper writing.

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
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • the surplus blastocysts
  • parents consent to donate the embryos

排除标准

  • not agree to participate in this program
  • whose embryo morphology and quality do not meet the technical requirements for genetic testing

研究组 & 干预措施

donated abandonment embryos

Other

Embryos biopsies for PGT-A (by use of NGS platforms from our institute) will be used for the validation of our Lab QC.

干预措施: NGS (Diagnostic Test)

结局指标

主要结局

Blastocyst aneuploidy rate

时间窗: 28 days

anormal Karyotype according to human genome 19 or updated version

次要结局

  • Whole genome amplification rate(7 days)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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