Validation of a Noninvasive Chromosome Screening (NICS) Method Using the Culture Medium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Presence of Mosaicism
研究概览
简要总结
This study aims to validate a non-invasive method of chromosomal screening (NICS), based on the Multiple Annealing and Looping Based Amplification Cycles- Next-generation Sequencing (MALBAC-NGS) technology, in order to determine the chromosomal endowment of a blastocyst from the DNA of the embryonic culture medium.
The chromosomal status of the embryo from an embryo biopsy of trophoectoderm will be established (usual clinical practice), the chromosomal endowment from the DNA of the embryonic culture medium will be determined, and the results using the NICS and the conventional invasive method (Preimplantation Genetic Testing for Aneuploidy [PGT-A]) will be compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Treatment by oocyte donation or own oocyte nd preimplantation genetic screening of aneuploidies (PGT-A).
- •Embryonic cryopreservation.
- •Informed consent signature
排除标准
- •Embryo transfer without embryo freezing
- •Embryonic block.
- •Bad embryo quality.
结局指标
主要结局
Presence of Mosaicism
时间窗: At Day 5-6 after FIV
Presence of mosaicism
Quality value of NICS DLRS
时间窗: At Day 5-6 after FIV
Quality value of noninvasive chromosome screening (NICS) derivative Log Ratio Spread (DLRS)
次要结局
未报告次要终点
研究者
Belen Lledo
Principal investigator
Instituto Bernabeu