Preimplantation Genetic Screening for Aneuploidy in Embryos After in Vitro Fertilization in Women Over 35: a Prospective Controlled Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical implantation rate per embryo transferred
研究概览
简要总结
In view of insufficient evidence to routinely use Preimplantation Genetic Screening (PGS) to improve success rates after IVF, we test the hypothesis that patients with advanced maternal age (AMA) have a higher implantation rate (IR) after embryo transfer (ET) of chromosomally normal embryos following PGS compared to patients who had an ET without PGS.
In a randomized controlled trial (RCT) in patients with AMA (≥ 35 years), the clinical IR per embryo transferred will be compared after ET on day 5 or 6 between the PGS group (embryo biopsy and analysis of chromosomes 13, 16, 18, 21, 22, X and Y) and the control group without PGS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All couples with a medical indication for IVF and with a female age of at least 35 years are invited to participate in the study.
排除标准
- •Cycles were excluded from the study if ≤ 2 fertilized oocytes were available on day 1 after oocyte retrieval (OR), or if ≤ 2 ≥ 6c stage embryos were available on day 3 after OR.
研究组 & 干预措施
PGS group
干预措施: Preimplantation genetic screening after embryo biopsy (Procedure)
control group
结局指标
主要结局
Clinical implantation rate per embryo transferred
时间窗: end of study
次要结局
- Pregnancy rate per transfer(end of study)