Preimplantation Genetic Testing for Aneuploidy by Next-generation Sequencing of Polar Bodies in Advanced Maternal Age With Poor Ovarian Responders: a Randomized Clinical Trial (Preliminary Experiments)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cumulative live birth rate
研究概览
简要总结
This study intends to randomly group the patients with advanced maternal age and poor ovarian response, and the study group will undergo polar body biopsy, and the next-generation sequencing(NGS) technology will be used to evaluate the polar body euploidy and then predict the euploidy of the oocyte. Embryo transfer priority according to the NGS test results and morphological scores. In the control group undergo routine culture and the transfer priority is determined according to the morphological score only. The transfer of frozen embryos at the cleavage or blastocyst stage was permitted. Cumulative live birth rate, miscarriage rate and time required to obtain a live birth up to two ovulatory cycles in a year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 36 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •patients between their 36th and 42st birthdays;
- •absence of any type of genetic abnormality in the patient's personal and family history;
- •MⅡ oocytes: 2-9 .
排除标准
- •treatment involving donor oocytes;
- •any type of genetic abnormality or family history of genetic abnormality in subject or partner;
- •with assisted reproductive technology and pregnancy contraindications and with diseases that have a definite effect on pregnancy;
- •poor embryo quality in previous cycles;
- •Preimplantation genetic testing for aneuploidy(PGT-A) cycles;
- •MⅡ oocytes ≥10 or ≤ 1;
- •three or more previous failed IVF or Intracytoplasmic sperm injection(ICSI) cycles.
结局指标
主要结局
Cumulative live birth rate
时间窗: 22 months
次要结局
- abortion rate(22 months)
- time required to obtained a live birth(22 months)