Aneuploidy Rates and Morphokinetic Parameters in Sibling Embryos Cultured in Distinct Culture Media
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Aneuploidy Rates
研究概览
简要总结
Embryonic aneuploidy is the underlying etiology for the majority of failed implantation and miscarriage. Preimplantation genetic screening (PGS) with transfer of a euploid embryo has been advocated as a strategy for increasing live birth rates with a single embryo transfer. Culturing embryos to the blastocyst stage for trophectoderm biopsy is a requirement for PGS. Several commercially-available single-step embryonic culture media with varying composition have been established for use in the IVF laboratory. Early reports have suggested differences in clinical outcomes, such as aneuploidy and miscarriage rates, with distinct culture media currently in standard use. However, there have been no clinical trials demonstrating the superiority of any one commercially-available culture media formulation. As a result, clinics use media with varying composition based upon familiarity and cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All subjects planning blastocyst culture for preimplantation genetic screening (PGS) will be offered enrollment.
- •Antral Follicle Count (AFC) >8 Male and female partner > 18 years of age
排除标准
- •Female partner age >42 years of age Cleavage stage biopsy
研究组 & 干预措施
SAGE Media
SAGE single-step MEDIA
干预措施: EmbryoScope Plus (Device)
SAGE Media
SAGE single-step MEDIA
干预措施: SAGE MEDIA (Other)
GLOBAL Media
LIFE GLOBAL single-step MEDIA
干预措施: EmbryoScope Plus (Device)
GLOBAL Media
LIFE GLOBAL single-step MEDIA
干预措施: GLOBAL MEDIA (Other)
结局指标
主要结局
Aneuploidy Rates
时间窗: Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment
number of embryos with abnormal chromosome number over total number of embryos biopsied (%)
次要结局
- Embryo Quality(2 weeks from start of IVF treatment)
- Embryo Morphokinetics(2 weeks from start of IVF treatment)
- Embryonic Mosaicism(Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment)
