Efficacy Evaluation of a Novel Diagnostic Assay Which is the Basis for Seaforia Diagnostic System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Semen Quality as determined by the following parameters: Semen volume
研究概览
简要总结
Evaluation of specificity and sensitivity of Seaforia- an vitro diagnostic system for evaluating semen quality.
详细描述
Quantities assessment of semen quality as defined by:
Semen volume, semen pH, leukocytes concentration, sperm cells concentration, motile sperm cell concentration, total motile sperm cells threshold and sperm cells morphology
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Capable and willing to sign a consent form and participate in the study
- •20<Age<45
排除标准
- 未提供
结局指标
主要结局
Semen Quality as determined by the following parameters: Semen volume
时间窗: The same day as sevan evaluation according to the gold standard
Semen pH
时间窗: The same day as sevan evaluation according to the gold standard
Sperm cells concentration
时间窗: The same day as sevan evaluation according to the gold standard
Motile sperm cell concentration
时间窗: The same day as sevan evaluation according to the gold standard
Sperm cells morphology
时间窗: The same day as sevan evaluation according to the gold standard
Leukocytes concentration
时间窗: The same day as sevan evaluation according to the gold standard
Total motile sperm cells threshold
时间窗: The same day as sevan evaluation according to the gold standard
次要结局
未报告次要终点