Assessing the Effect of Abstinence Period on Semen Parameters
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in semen analysis parameters based on different abstinence periods: sperm concentration
研究概览
简要总结
The goal of this study is to learn about the impact of abstinence periods on sperm quality in healthy males 20-45 years of age with no significant comorbidities who are able to produce a semen sample via masturbation. The main question it aims to answer is:
• Do shorter abstinence periods result in improved semen quality?
Participants will provide semen samples for analysis following abstinence periods of 7 days, 5 days, 2 days, 1 day, and 3 hours.
详细描述
Participant Duration: Total length of time on study per subject is 14 days (including 5 days of visit required for sample production). Subjects do not need to complete the visits in order but need to document abstinence period prior to sample production. No follow up will be needed after the study.
Primary Objective: The primary objective is to examine the differences in semen analysis parameters after varying abstinence periods (7 days, 5 days, 2 days, 1 day, 3 hours).
Secondary Objectives: The secondary objective(s) is to assess changes in sperm DNA fragmentation after varying abstinence periods (7 days, 5 days, 2 days, 1 day, 3 hours).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Males, aged 20-45 years
- •Healthy, no significant comorbidities
- •Able to produce a semen sample by masturbation
- •Total sperm count ≥ 1 million sperm
- •Abnormal sperm DNA fragmentation (TUNEL assay value ≥ 20%)
排除标准
- •Age < 20 or > 45 years
- •Significant comorbidities, including significant cardiac, pulmonary, gastrointestinal, hematologic, or neurologic disease
- •Total sperm count < 1 million sperm
- •Aspermia (semen volume = 0)
- •Normal sperm DNA fragmentation (TUNEL assay value < 20%)
研究组 & 干预措施
Healthy Volunteers
Healthy males with no significant comorbidities, aged 20-45 years who are able to produce a semen sample by masturbation.
干预措施: Abstinence followed by semen sample collection. (Other)
结局指标
主要结局
Change in semen analysis parameters based on different abstinence periods: sperm concentration
时间窗: 7 days, 5 days, 2 days, 1 day, 3 hours
The primary objective is to examine the differences in semen analysis parameters (sperm concentration measured in million sperm/mL) after varying abstinence periods (7 days, 5 days, 2 days, 1 day, 3 hours).
Change in semen analysis parameters based on different abstinence periods: volume
时间窗: 7 days, 5 days, 2 days, 1 day, 3 hours
The primary objective is to examine the differences in semen analysis parameters (volume in mL) after varying abstinence periods (7 days, 5 days, 2 days, 1 day, 3 hours).
Change in semen analysis parameters based on different abstinence periods: motility
时间窗: 7 days, 5 days, 2 days, 1 day, 3 hours
The primary objective is to examine the differences in semen analysis parameters (motility measured as a percentage) after varying abstinence periods (7 days, 5 days, 2 days, 1 day, 3 hours).
次要结局
- Change in sperm DNA fragmentation based on different abstinence periods(7 days, 5 days, 2 days, 1 day, 3 hours)