NCT00741494已完成不适用
Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI) for Patients Having a Low Versus High Proportion of Hyaluronan Binding Sperm (HBA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biocoat
- 入组人数
- 801
- 试验地点
- 18
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
The purpose of this study is to determine if using microdots of hyaluronan (PICSI) to select sperm for ICSI will result in increased pregnancies especially with men that have a low hyaluronan binding score (HBA).
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IVF patients who require the ICSI procedure and whose care is being managed by the clinical and scientific staff of the participating groups, will be included in the study.
排除标准
- •IVF patients who do not require the ICSI procedure will be excluded from the study. In addition the following groups of patients will also be excluded:
- •Patients using testicular sperm.
- •Patients using donor sperm.
- •Patients where the female partner is over 40 years of age
- •Patients who have an initial HBA score less than or equal to 2%
- •Patients who have a sperm count less than or equal to 10,000 motile sperm per ml.
- •Patients who produce less than 4 Metaphase II oocytes
结局指标
主要结局
Clinical pregnancy rate
时间窗: 8 weeks post ICSI
次要结局
未报告次要终点
研究者
研究点 (18)
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