试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- To validate and develop the Eeva Software.
研究概览
简要总结
The purpose of this study is to demonstrate that the Eeva™ System is compatible with the Eeva 12-well Dish.
详细描述
This study is designed to demonstrate that the Eeva System Software successfully tracks the embryo images and identifies the timing of key developmental events using the Eeva 12-well Dish.
This is a prospective, observational, blinded, single arm, nonrandomized, single center clinical study. Images of developing embryos and Eeva predictions will be blinded to embryologists and physicians
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 —（Adult, Older 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 at least 18 years of age.
- •Subject has basal antral follicle count (BAFC) ≥ 12 prior to stimulation cycle.
- •Subjects has basal FSH < 11 IU
- •Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
- •Subject has at least 8 normally fertilized eggs (2PN)
- •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.
- •Any other reason the Investigator believes the subject should not participate in the clinical study.
结局指标
主要结局
To validate and develop the Eeva Software.
时间窗: 3 months
The clinical image data (embryos images) will be used to develop the Eeva System Software. The Eeva software validation will consist in comparing the specificity of the Eeva System Software Blastocyst Prediction from the Eeva 12-well Dish to the specificity of the Eeva System Software from the Eeva 25-well Dish (the specificity of the Eeva System Software from the Eeva 25-well Dish was previously determined during the Eeva System Study TST-1788-r).
次要结局
- Specificity and sensitivity and 95% confidence intervals of the Eeva System Software and the Embryologist Panel (also referred to as Panel) measurements will be computed.(3 months)