A Randomized Clinical Trial for Advanced Decision Support Tool, Opt-IVF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Number of Grade A embryos
研究概览
简要总结
Aim: A Clinical trial to determine the effectiveness of using the proposed decision support tool for each patient's customized optimal drug dosage profile. This will be a two-arm clinical trial involving 200 patients; one arm will undergo superovulation using dosages predicted by the decision support tool while the other arm will undergo current standard treatment. The investigators will compare the outcomes of the two groups of patients in terms of the numbers and percentage of mature follicles retrieved at the end of each cycle, total FSH and HMG dosages used, and the number of required testing days for that cycle. The patients considered will include all ages, with and without PCOS, and low, average, and high responders.
详细描述
Objectives/Aims
Aim: A Clinical trial to determine the effectiveness of using the proposed decision support tool for each patient's customized optimal drug dosage profile.
Subject Enrollment
The recruitment plan designed is study-specific and site-specific. The investigators plan to recruit patients by reaching into the center's own database of patients. This 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Only care provider Dr. Patel will know the identity of each patient.
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
- •women between 18 to 50 years of age
排除标准
- •men and children
结局指标
主要结局
Number of Grade A embryos
时间窗: At the end of cycle 1 (each cycle is 17 days)
average number of grade A embryos per cycle
Number of mature oocytes retrieved
时间窗: At the end of cycle 1 (each cycle is 17 days)
average oocytes retrieved
Number of Metaphase 2 follicles
时间窗: At the end of cycle 1 (each cycle is 17 days)
average number of M2s obtained per cycle
Number of Ultrasounds
时间窗: At the end of cycle 1 (each cycle is 17 days)
average number of ultrasounds per cycle
Number of Embryos
时间窗: At the end of cycle 1 (each cycle is 17 days)
average number of Embryos per cycle
Total per cycle dosage
时间窗: At the end of cycle 1 (each cycle is 17 days)
Average dosage per cycle
次要结局
- Pregnancy rate(0-3 months)