A Novel Sperm Selection Method Provides Advantages Over Conventional Approaches: Validation Through a Clinical Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Sperm intracellular Calcium
研究概览
简要总结
The goal of this clinical trial is to know if a novel sperm selection device (CA0) has a similar performance than the standard selection method in teratozoospermic and azoospermic men. The main questions it aims to answer are:
Does the CA0 sperm selection device increases the sperm concentration? Does the CA0 sperm selection device increases the sperm motility? What are the differences in sperm membrane potential when CA0 is used? Do intracellular Calcium levels change when CA0 is used? Does CA0 increase fertilization rates? Researchers will compare CA0 to the standard of care for sperm selection (density gradient centrifugation) to see if CA0 has similar performance
Participants will:
Provide a semen sample Have their semen sample analyzed, processed and used for assisted reproduction technologies
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants did not know if their sperm would be selected by density gradient centrifugation ir the novel device (CA0 chamber)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Normozoospermic (18-35 years old) and teratozoospermic (18-60 years old) patients undergoing IVF/ICSI cyles with at least 2 days of sexual abstinence
排除标准
- •Less than 4 oocytes collected during oocyte retrieval
- •Total sperm count less than 30x10^6
结局指标
主要结局
Sperm intracellular Calcium
时间窗: Within 2 hours from the sperm collection
Evaluation of the progesterone-induced intracellular calcium fluorescent peaks after sperm selection
Sperm motility
时间窗: Within 2 hours from the sperm collection
Percentage of progresive, non-progressive and immotile sperm after sperm separation
Sperm concentration
时间窗: Within 2 hours from the sperm collection
Assessment of sperm count after sperm separation
Sperm membrane potential
时间窗: Within 2 hours from the sperm collection
Evaluation of the KCl-induced difference of membrane potential voltage in mV, after sperm selection.
Fertilization rates
时间窗: 17-20 hours after insemination by IVF or ICSI
Determination of the rate of 2 pronucleous, 2 polar bodies zygotes after insemination
次要结局
未报告次要终点
研究者
Liliana Berenice Ramírez Domínguez
Scientific Coordinator
Center of Innovation Technology & Reproductive Medicine