Randomized Investigation With an AI Powered Medical Device to Select the First Dose of FSH for Controlled Ovarian Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Number of MII oocytes
研究概览
简要总结
The study aims to evaluate the effectiveness of an individualized FSH dosing model called IDoser in controlled ovarian stimulation (COS) for assisted reproduction. The randomized, controlled, multicenter trial involves 236 first cycle IVF patients, who will be assigned to either the intervention arm (using the IDoser model) or the control arm (standard clinician-determined dosing). The primary outcome is the number of mature oocytes retrieved, with the hypothesis of non-inferiority for the intervention arm. Secondary outcomes include cycle cancellations, risk of ovarian hyperstimulation syndrome (OHSS), and pregnancy and live birth rates.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded to arm allocation. The research team will also be blinded, with the exception of the data coordinator. The medical team, with the exception of the ones assigned to care for the participants, will also be blinded to arm allocation. The embryology laboratory team will also be blinded.
入排标准
- 年龄范围
- 18 Years 至 51 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •First IVF cycles
- •Use of autologous oocytes
- •Use of FSH on the first day of stimulation (which can be combined with luteinizing hormone, LH).
排除标准
- •Natural ovarian stimulation cycles (without Controlled ovarian stimulation)
- •Cycles where FSH is not measured in International Units (IU).
结局指标
主要结局
Number of MII oocytes
时间窗: 3 weeks (from enrollment to oocyte pick-up)
Total number of mature MII oocytes retrieved at oocyte pick-up
次要结局
- Live birth rate(44 weeks (from enrollment to baby delivery))
- OHSS risk(3 weeks (from enrollment to oocyte pick-up))
- Cycle cancellation rate(3 weeks (from enrollment to oocyte pick-up))
- Clinical pregnancy rate(10 weeks (from enrollment to detection of fetal heart beat))