NCT04969822已完成不适用
Will Embryo Selection Through Use of Artificial Intelligence (iDA) Perform Equally Compared to Day 5 Morphology?
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Vitrolife
- 入组人数
- 1,066
- 试验地点
- 28
- 主要终点
- Clinical Pregnancy Rate
研究概览
简要总结
A non-inferiority, prospective parallel group, multi-center, randomized controlled trial to investigate whether selection of a single blastocyst for transfer using the deep learning tool, iDA, results in non-inferior clinical pregnancy rate compared to trained embryologists using standard morphology criteria.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women undergoing IVF or ICSI with controlled ovarian stimulation with gonadotrophins and the intention to treat by either transfer of a single fresh embryo on day 5 or in case of a freeze all cycle, the first rewarmed embryo.
- •Age: Up to and including the 42nd completed birthday on the day of randomization.
- •Has at least two early blastocysts on day 5.
排除标准
- •Treatment involving donated eggs
- •Intention to perform any form of preimplantation genetic testing
- •The use of IMSI or polarized light in the ICSI process
- •The use of assisted hatching prior to randomization
- •Previous participation in this RCT
- •Where the cycle is carried out for fertility preservation
- •If a day 2-4 transfer is planned
- •Has a reduced likelihood of obtaining two early blastocysts on day 5 as evidenced by either: an AMH level of <3pmol/L or AFC <5 (if available)
结局指标
主要结局
Clinical Pregnancy Rate
时间窗: After 7-9 weeks of gestation
Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed
次要结局
- Live Birth Rate(9 months)
- Positive hCG Rate Per Randomized Patient(Tested on day 9-13 following embryo transfer)
- Rate of Non-viable Pregnancies(After 7-9 weeks of gestation)
- Ongoing Pregnancy Rate(After 7-9 weeks of gestation)
研究者
研究点 (28)
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