The Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Cumulative clinical pregnancy rate
研究概览
简要总结
This is a randomized controlled trial comparing density gradient centrifugation and microfluidic sperm sorting in patients undergoing intrauterine insemination to evaluate cumulative pregnancy outcomes.
详细描述
Study participants will be randomized to either standard sperm preparation (density gradient centrifugation) versus sperm preparation with the Zymot Multi sperm preparation device for their three month intrauterine insemination treatment course. Patients will follow standard treatment plans designed by their fertility physician and will be followed until referred for prenatal care at 8-10 weeks of pregnancy to determine pregnancy outcomes.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing intrauterine insemination
- •Patient assigned female at birth with age <41
排除标准
- •Any significant disease or psychiatric disorder that would interfere with the consenting process
- •Prior intrauterine insemination
- •Use of frozen donor sperm
- •Non-English speaker
研究组 & 干预措施
Density gradient centrifugation
Patients will undergo sperm preparation by density gradient centrifugation
干预措施: Density gradient centrifugation (Other)
Zymot sperm separation device
Patients will undergo sperm preparation by the Zymot sperm separation device
干预措施: Zymot Multi sperm separation device (Device)
结局指标
主要结局
Cumulative clinical pregnancy rate
时间窗: 3 treatment cycles, an average of 5 months
The clinical pregnancy rate by treatment group over the course of IUI treatment
次要结局
未报告次要终点