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临床试验/NCT03725696
NCT03725696终止不适用

The Effect of Bariatric Surgery on Spermatogenesis

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
25
试验地点
1
主要终点
Changes in sperm concentration

研究概览

简要总结

Little is known about the effects of weight loss surgery on male reproductive health. This study will investigate the effect of bariatric surgery on male infertility by evaluating sexual health, blood hormone levels, and semen parameters before and after roux-en-y bariatric surgery.

详细描述

Obesity is a worldwide epidemic that has numerous health consequences including male infertility. Prior studies have shown a variety of health benefits with bariatric surgery, including an improvement/resolution in diabetes and a significant improvement in serum testosterone levels. Based upon preliminary data from the literature, the investigators hypothesize that bariatric surgery is associated with a transient decrease followed by a robust long-term improvement in semen parameters including DNA fragmentation and oxidative stress. To test this hypothesis, the investigators propose a prospective observational study examining changes in hormone and semen parameters over the 12 months following Roux-en-Y gastric bypass surgery. The investigators will correlate these changes to weight loss, changes in subjective sexual function, and advanced semen parameters including DNA fragmentation. If successful, this study will conclusively identify a new modifiable cause for male infertility and suggest an additional medical indication for bariatric surgery in obese infertile men.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Men aged 18-55
  • Undergoing Roux-en-Y bariatric surgery

排除标准

  • History of undescended testes
  • Prior scrotal surgery
  • Known karyotypic abnormalities

结局指标

主要结局

Changes in sperm concentration

时间窗: Baseline to 12 months

Changes in sperm concentration on semen analysis

次要结局

  • Weight loss(Baseline to 12 months)
  • Changes in sexual health(Baseline to 12 months)
  • Changes in reproductive hormones(Baseline to 12 months)
  • Changes in seminal oxidative stress(Baseline to 12 months)
  • Changes in sperm morphology(Baseline to 12 months)
  • Changes in seminal DNA fragmentation(Baseline to 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Scott Lundy

Resident Physician

The Cleveland Clinic

研究点 (1)

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