An Advanced Decision Tool Opt-IVf for Personalized Medicine for IVF Using Modeling and Optimization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Number of Mii Follicles
研究概览
简要总结
A multi-center randomized clinical trial is proposed to study the effectiveness of the advanced decision support tool Opt-IVF for ALL PROTOCOLS in reducing medication, testing, and improving outcomes.
详细描述
Aim: A Multi-center Randomized Clinical trial to determine the effectiveness of using the proposed decision support tool for ALL PROTOCOLS for each patient's customized optimal drug dosage profile.
Subject Enrollment
There are 13 centers involved in this trial. The recruitment plan designed is study-specific and site-specific. The investigators plan to recruit patients by reaching into the each center's own database of patients. Each center carries out on average 800 IVF cycles per year. PIs anticipate easier recruitment since they are not excluding any IVF patients, whether they are low, high, or average responders undergoing any protocol or patients with PCOS or not. The in-reach activities to be used include:
Chart review from site patient database Establishing an internal referral network with all physicians within the site Educational meetings with providers and physicians Educational sessions with patients and relatives Financial assistance to patients undergoing the intervention Training staff to facilitate ICF process by o Effectively conveying risks and benefits Creating an open environment Monthly calls to site physicians and staff to convey success stories
The retention activities include:
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
The investigator and outcomes assessor Dr. Urmila Diwekar will only know the de-identified patient details in each arm after the treatment.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •• All-female patients undergoing IVF with own oocyte
排除标准
- 未提供
结局指标
主要结局
Number of Mii Follicles
时间窗: at the end of cycle (each cycle is 17 days)
Number of Mii Follicles
Number of Grade A embryos
时间窗: at the end of cycle (each cycle is 17 days)
Number of Grade A embryos
Number of Follicles retrieved
时间窗: at the end of cycle (each cycle is 17 days)
Mature follicles retrieved
Clinical Pregnancy Rate
时间窗: One month after implantation
Clinical Pregnancy Rate
Total number of Embryos
时间窗: at the end of cycle (each cycle is 17 days)
Total number of Embryos
Total FSH+HMG Dosage in IUI for the complete cycle
时间窗: at the end of cycle (each cycle is 17 days)
Total FSH+HMG Dosage in IUI for the complete cycle
次要结局
未报告次要终点