NCT02218255Unknown不适用
Eeva™ Pregnancy Pilot Study (PPS)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Clinical Pregnancy
研究概览
简要总结
The purpose of this clinical investigation is to gather pilot data to evaluate the impact of using Eeva™, a time-lapse enabled embryo test, in combination with traditional morphology on clinical pregnancy rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •≤ 40 years
- •≥ 4 diploid embryos (i.e. having 2 PNs)
- •≤ 3 Prior ART cycles (IVF, ICSI and related procedures)
- •All 2PN embryos (for all 3 arms) must be imaged by Eeva
- •Subject willing to comply with study protocol and procedures
- •Subject willing to provide written informed consent
排除标准
- •Preimplantation genetic diagnosis or preimplantation genetic screening
- •Planned "freeze all" cycle (eggs or embryos)
- •Asherman's Syndrome
- •Donor egg
- •Gestational carrier
- •Presence of Hydrosalpinx on ultrasound
- •Concurrent participation in an interventional clinical study
结局指标
主要结局
Clinical Pregnancy
时间窗: 7-8 weeks gestation
次要结局
- Ongoing pregnancy rate(8-12 week gestation)
研究者
研究点 (2)
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