A Comparison of Two Models Used for Identifying Embryos With the Best Chance of Inducing Pregnancy: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Vitrolife
- 入组人数
- 165
- 试验地点
- 4
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
A pilot study to gather information on clinical pregnancy rates for preparation of the planning of a larger randomized controlled trial comparing two decision support tools: the deep learning tool iDAScore® and the current annotation model, KIDScore™ D5.
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
- •Patients undergoing IVF/ICSI-treatment with controlled ovarian stimulation with gonadotrophins and the intention to treat by transfer of a single day 5 fresh blastocyst on day
- •At least two good quality blastocysts (GQB) on day 5 (3BB or better on the Gardner scale), originating from normally fertilized oocytes (2PN).
排除标准
- •Previous participation in this RCT
- •Concurrent participation in another investigation
- •Intention to perform any form of preimplantation genetic testing
- •Fertility preservation
- •Planned transfer on day 2-4
- •Female age >42 years
- •A reduced likelihood of obtaining two good quality blastocysts on day 5 as evidenced by an AFC <5 (if available, AFC=antral follicle count)
研究组 & 干预措施
Embryo selection supported by KIDScore™ D5
Each embryo reaching at least developmental stage of 3BB will annotated by an embryologist using the parameters required by the KIDScore™ D5. The embryo with the highest KIDScore™ will be selected proposed for transfer.
Embryo selection supported by iDAScore®
Images of all the embryos reaching at least developmental stage of 3BB will be analyzed by iDAScore®. The embryo with the highest iDAScore® will be proposed selected for transfer.
干预措施: iDAScore® (Device)
结局指标
主要结局
Clinical pregnancy rate
时间窗: After 6 weeks of gestation
Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed
次要结局
- Rate of non-viable intrauterine pregnancies per randomized patient(After 6 weeks of gestation)
- Clinical pregnancy rate in patients with maternal age above 35(After 6 weeks of gestation)
- Positive hCG rate per randomized patient(From day 13 following embryo transfer)