NCT03725696

The Effect of Bariatric Surgery on Spermatogenesis

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bariatric Surgery Candidate
• Sexual Function and Fertility Disorders

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Semen Analysis	Sperm counts will be determined by semen analysis.
DIAGNOSTIC_TEST	Hormonal panel	Blood test for LH, FSH, testosterone, and estradiol
PROCEDURE	RYGB Gastric Bypass	Roux-en-Y Gastric Bypass
DIAGNOSTIC_TEST	IIEF Survey	International Index of Erectile Function is a validated 5-question survey examining sexual health in men

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-07-31
• Completion: 2020-12-31
• First posted: 2018-10-31
• Last updated: 2021-04-09

Locations

1 site across 1 country: United States