Evaluation of the Alife Hera System as an Adjunctive Tool for the Prioritization of Embryos Deemed Suitable for Transfer: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- Alife Health
- 入组人数
- 440
- 试验地点
- 14
- 主要终点
- Primary Endpoint
研究概览
简要总结
To evaluate the clinical pregnancy rate (pregnancy defined as fetal heartbeat at 6-8 weeks) with the adjunctive use of the Hera System (Hera System used with traditional morphological grading) with embryos already deemed suitable for transfer compared to trained embryologists using standard morphology criteria alone.
详细描述
To evaluate the clinical pregnancy rate (pregnancy defined as fetal heartbeat at 6-8 weeks) with the adjunctive use of the Hera System (Hera System used with traditional morphological grading) with embryos already deemed suitable for transfer compared to trained embryologists using standard morphology criteria alone.
To evaluate the performance and utilization of the Hera System as an adjunctive embryo grading and prioritization tool in an embryology lab setting with trained embryologists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •>21 and < 43 years of age
- •Women undergoing in vitro fertilization treatment using their own eggs
- •At least 8 eggs retrieved
- •Fertilization using only ejaculated sperm including donor sperm (fresh or frozen)
- •Single embryo transfer (SET)
- •Willing to comply with study protocol and procedures and be able to speak English
- •Willing to provide written informed consent
排除标准
- •Gestational carriers
- •Use of re-inseminated eggs
- •Use of donor eggs
- •History of cancer
- •Fertilization using surgically removed sperm
- •Transfer of multiple (more than one) embryos at once
- •Participants undergoing IVF with intent to bank embryos (i.e. no intention of embryo transfer for at least 6 months following egg retrieval)
- •Concurrent participation in another clinical study that might interfere with the study results in either study
结局指标
主要结局
Primary Endpoint
时间窗: up to 8 weeks
The primary study endpoint is clinical pregnancy - defined as a fetal heartbeat at 6-8 weeks.
次要结局
- Incidence of disagreement(week 1)
- User Experience(through study completion at 8 weeks)