A Phase IV, Prospective, Randomized, Exploratory, Multicenter, Eeva™ Trial (Time Lapse Eeva - TiLE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 976
- 试验地点
- 23
- 主要终点
- Implantation Rate
研究概览
简要总结
The purpose of the study was to explore the added value of adjunctive use of Early Embryo Viability Assessment (Eeva) with morphological grading in identifying optimal embryos for transfer.
详细描述
This study is a Phase IV, open label, prospective, randomized, exploratory, multicenter study. Subjects were randomized in 2:1 ratio to two treatment groups: in the experimental group, embryos were assessed for embryo transfer (ET) with Eeva and morphological grading, while in the control group embryos were assessed with morphological grading only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •All infertile subjects treated with In vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI)
- •Subject age less than or equal to (<=) 40 years
- •Less than or equal to (<=) 3 failed IVF/ICSI cycles
- •At least 4 normally fertilized eggs (2 pronuclei [2PN]) in current cycle
- •Normal uterine cavity
- •Fertilization using only ejaculated sperm (fresh or frozen)
- •Subject must have read and signed the Informed Consent Form
排除标准
- •Have clinically significant systemic disease
- •Have abnormal, undiagnosed gynecological bleeding
- •Have any contraindication to Controlled Ovarian Stimulation (COS) for assisted reproductive technologies (ART) and to gonadotropins to be used in ART
- •Egg donor cycle
- •Planned "freeze all" cycle (oocytes or embryos)
- •Concurrent participation in another clinical trial
研究组 & 干预措施
Early Embryo Viability Assessment + Morphological Grading
Embryos of subjects randomized in this group were assessed using Early Embryo Viability Assessment (Eeva) System and morphological grading to identify optimal embryos for transfer.
干预措施: Eeva (Device)
Morphological Grading
Embryos of subjects randomized in this group were assessed only using morphological grading to identify optimal embryos for transfer.
结局指标
主要结局
Implantation Rate
时间窗: Gestational Weeks 5 to 8
Implantation rate was calculated by dividing the number of intrauterine gestational sacs by the number of embryos transferred multiplied by 100.
次要结局
- Clinical Pregnancy Rate(Gestational Weeks 5 to 8)
- Number of Subjects With Ongoing Pregnancy Status(Gestational Weeks 10 to 12)
- Multiple Pregnancy Rate(Gestational Weeks 5 to 8)
- Utilization Rate(Day 3 or Day 5/6 of embryo culture)
- Spontaneous Miscarriage Rate(Gestational Weeks 10 to 12)