An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization for PPOS
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Total Gonadotropin Dosage
研究概览
简要总结
A clinical trial will determine the effectiveness of using the Opt-IVF decision support tool for each patient's personalized and optimal drug dosage profile in the United States.
详细描述
This will be a two-arm randomized clinical trial involving more than 100 patients; one arm will undergo superovulation using dosages predicted by the decision support tool, while the other will undergo the current standard treatment. The research question is whether outcomes of patient dosage treatment using Opt-IVF are better or similar to the current practice. We 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, total number of M2s, Number of embryos, Number of Grade A embryos and Number of Grade A blastocysts.
The trial is for research purposes only. The current tool has not been submitted for any regulatory body approval.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •infertile women
排除标准
- •All female patients who will not undergo IVF or whose cycles will be converted to IUI. Male patients will not be enrolled in this study. No donor cycles.
研究组 & 干预措施
Control
This arm will get dosage prescribed by the doctor
干预措施: Control (Other)
Opt-IVF
This arm patients will get dosage provided by Opt-IVF
干预措施: Opt-IVF (Combination Product)
结局指标
主要结局
Total Gonadotropin Dosage
时间窗: Two weeks after the start of the cycle
Total Gonadotropin Dosage for the cycle
Total Oocytes Retrieved
时间窗: Two weeks after the start of the stimulation cycle
Total Oocytes Retrieved
M2 Oocytes
时间窗: Two weeks after the start of the stimulation cycle
Total M2 Oocytes
Total Embryos Formed
时间窗: Two weeks after the start of stimulation cycle
Total Embryos Formed
Grade A embryos/Blastocytes
时间窗: Three weeks after the start of stimulation cycle
Grade A Day 3 Embryos or Grade A Day 5 Blastocytes
次要结局
- Pregnancy Rates(one month after first transfer)
研究者
Urmila DIwekar
President
Stochastic Research Technologies LLC