An Advanced Decision Support Tool for Gonadotrophin Dose Modulation in Artificial Reproductive Technique.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of Follicles retrieved
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 in reducing medication, testing, and improving outcomes.
详细描述
IAim: A Multi-center Randomized 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 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• All-female patients undergoing IVF with own oocyte
排除标准
- •Endometriosis
- •Uncontrolled Diabetes
- •Uncontrolled thyroid abnormalities Uncontrolled hyperprolactinemia
结局指标
主要结局
Number of Follicles retrieved
时间窗: at the end of cycle (each cycle is 17 days)
Mature follicles retrieved
Total Number of Embryos
时间窗: at the end of cycle (each cycle is 17 days)
Total Number of Embryos fertilized
Number of high-quality blastocyte
时间窗: at the end of cycle (each cycle is 17 days)
Total number of high-quality blastocyte
Number of M2 follicles
时间窗: at the end of cycle (each cycle is 17 days)
Total Number of M2 follicles
Total FSH+HMG Dosage for the complete cycle
时间窗: at the end of cycle (each cycle is 17 days)
Total FSH+HMG Dosage for the complete cycle
Pregnancy rate
时间窗: after the end of cycle(each cycle is 17 days)
pregnancy rate
次要结局
未报告次要终点