Eeva Continued Access Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 3
- 主要终点
- User questionnaire of Eeva System usability and reports of device malfunctions.
研究概览
简要总结
User questionnaire of Eeva System usability and reports of device malfunctions.
详细描述
This study is designed to evaluate the use of Eeva by IVF laboratory staff during routine procedures. The fertilized eggs will be placed in an Eeva dish and the development of the embryos will be monitored by the Eeva system in a standard incubator. On day 3 of embryo culture, Eeva blastocyst prediction data will be printed from the system to be used to assist the embryologist in selecting the best embryo(s). The performance of the system will be summarized and the user feedback from the embryologists will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs
- •Subject is ≥ 18 and ≤ 40 years of age.
- •Subject has basal antral follicle count (AFC) ≥ 8 prior to stimulation cycle.
- •Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
- •Subject has ≥ 5 normally fertilized eggs (2 PN)
- •Willing to have all 2PN embryos monitored by Eeva
- •Willing to comply with study protocol and procedures and able to speak English.
- •Willing to provide written informed consent.
排除标准
- •Reinseminated eggs.
- •History of cancer.
- •Gestational carriers.
- •Planned preimplantation genetic diagnosis or preimplantation genetic screening.
- •Previously enrolled in this study
- •Concurrent participation in another clinical study.
结局指标
主要结局
User questionnaire of Eeva System usability and reports of device malfunctions.
时间窗: Participants will be followed through ongoing pregnancy, at approximately 10-12 weeks gestational age.
次要结局
未报告次要终点