Weight Loss Surgery and Male Fertility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in semen analyses and reproductive hormone measurements
研究概览
简要总结
A correlation between obesity and male fertility has been observed in a few clinical studies. Normal weight men appear to have higher sperm concentrations and sperm motility when compared to obese men, suggesting that weight loss might improve sperm function. However, there also are reported cases of severe male factor infertility following weight loss surgery in previously fertile men. The aim of this study is to determine if there are differences in the semen analyses and hormone levels of men obtained before and after undergoing weight loss (bariatric) surgery.
This will direct future research and treatment.
详细描述
We will recruit 60 subjects for this study. Volunteers will provide pre-operative semen and blood samples prior to undergoing weight-reduction surgery.
Those with normal pre-operative sperm samples will be invited to continue participating in the study by providing subsequent post-operative semen samples and hormonal testing over a two year time period.
It is estimated to take approximately one year to enroll the desired 60 subjects. The study will conclude two years from the last enrollment.
The main analysis will be a comparison of sperm concentrations over time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult male subjects between the ages of 18-65 undergoing bariatric surgery
排除标准
- •Subjects with abnormal sperm analysis
结局指标
主要结局
Changes in semen analyses and reproductive hormone measurements
时间窗: 2 years
次要结局
- Trends in semen analysis & reproductive hormone parameters over the two-year data collection period, Changes in semen analysis & reproductive hormone parameters as a function of BMI(2 years)