The Effect of Bariatric Surgery on Spermatogenesis

Bariatric Surgery Candidate Clinical Trial

Official title:

The Effect of Bariatric Surgery on Spermatogenesis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03725696
• Other study ID #: IRB 16-721
• Status: Terminated
• Start date: November 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: December 31, 2020
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Men aged 18-55

• Undergoing Roux-en-Y bariatric surgery

Exclusion Criteria:

• History of undescended testes

• Prior scrotal surgery

• Known karyotypic abnormalities

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Sexual Function and Fertility Disorders

Intervention

Diagnostic Test:
• Semen Analysis
Sperm counts will be determined by semen analysis.
• 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

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in sperm concentration	Changes in sperm concentration on semen analysis	Baseline to 12 months
Secondary	Weight loss	Change in weight following bariatric surgery	Baseline to 12 months
Secondary	Changes in sexual health	Change in International Index of Erectile Function (IIEF) score, a validated questionnaire with scores ranging from 1 (significant erectile dysfunction to 30 (no erectile dysfunction).	Baseline to 12 months
Secondary	Changes in reproductive hormones	Changes in FSH, LH, testosterone, and estrogen blood levels	Baseline to 12 months
Secondary	Changes in seminal oxidative stress	Changes in seminal reactive oxygen species	Baseline to 12 months
Secondary	Changes in sperm morphology	Changes in percent normal sperm morphology on semen analysis	Baseline to 12 months
Secondary	Changes in seminal DNA fragmentation	Changes in seminal DNA fragmentation rate on semen analysis	Baseline to 12 months