Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Rate of clinical pregnancy
研究概览
简要总结
The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates.
详细描述
The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates, as compared to a matched case control group that used morphology grading only to select embryos for transfer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
入排标准
- 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.
- •IVF cycle attempts ≤
- •Egg age ≤ 40 years.
- •Planned Day 3 embryo transfer.
- •At least 5 normally fertilized eggs (2PN).
- •All 2PN embryos must be imaged by Eeva.
- •Normal uterine cavity as evaluated by standard methods.
- •Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
- •Willing to comply with study protocol and procedures.
- •Willing to provide written informed consent.
排除标准
- •Planned preimplantation genetic diagnosis.
- •Planned "freeze all" cycle (oocytes or embryos).
- •Concurrent participation in another clinical study.
结局指标
主要结局
Rate of clinical pregnancy
时间窗: 5-8 weeks gestational age
To compare the rate of clinical pregnancy at approximately 5-8 weeks gestational age for the Day 3 embryo transfers that used Eeva predictions with morphology grading to that for Day 3 embryo transfers using morphology grading only (from a matched concurrent control group at each clinical site comprised of year 2011-2013 patients).
次要结局
- Ongoing Pregnancy Rate (gestational week 10-12)(Gestational age week 10-12)
- Multiple pregnancy rate(Gestational weeks 5-8 and 10-12)
- Implantation rate (# of implanted embryos out of # of total embryos transferred)(5-8 weeks gestational age.)
- Spontaneous miscarriage rate(Gestational age week 10-12)