Prospective Observational Study Utilizing the Eeva™ System 2.2.1 for Ongoing Collection of Development and Validation Data
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 7
- 主要终点
- Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit.
研究概览
简要总结
The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.
详细描述
The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.
Primary Objectives Include:
To collect imaging data on embryos followed to blastocyst stage (Day 5-6)
Secondary Objectives Include:
To collect enrollment data: demographics, IVF and pregnancy history To collect Day 3, Day 5 and Day 6 embryo morphology data To collect pregnancy test and outcome data To collect pre-implantation genetic screening (PGS) data (if applicable) To collect Frozen Embryo Transfer (FET) data (if applicable)
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •Women undergoing in vitro fertilization treatment using their own eggs
- •Fresh or Frozen Blastocyst (Day 5-6) transfer
- •At least 5 diploid (2PN) embryos at fertilization check
- •Willing to have all 2PN embryos imaged by Eeva
- •Willing to comply with study protocol and procedures
- •Willing to provide written informed consent
排除标准
- •Freeze-all due to ovarian hyperstimulation syndrome (OHSS)
- •Use of donor egg / gestational carrier
- •Fertilization using surgically removed sperm
- •History of cancer
- •Assisted Hatching (AH) on Day 3
结局指标
主要结局
Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit.
时间窗: 36 months
次要结局
未报告次要终点