The Effect of Bariatric Surgery on Spermatogenesis

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.

Study Overview

• Status: Terminated
• Conditions: Bariatric Surgery Candidate; Sexual Function and Fertility Disorders
• Intervention / Treatment: Diagnostic test: Semen Analysis; Diagnostic test: Hormonal panel; Procedure: RYGB Gastric Bypass; Diagnostic test: IIEF Survey

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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men between the ages of 18 and 50 scheduled for bariatric surgery who meet the above enrollment criteria will be offered enrollment in the study at the time of their preoperative clinic visit.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational group; Patients who are booked for RYGB gastric bypass surgery and enroll in the study will undergo semen analysis, sexual health questionnaire (IIEF survey), and a blood hormonal panel before and after surgery.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in sperm concentration	Changes in sperm concentration on semen analysis	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	Change in weight following bariatric surgery	Baseline to 12 months
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
Changes in reproductive hormones	Changes in FSH, LH, testosterone, and estrogen blood levels	Baseline to 12 months
Changes in seminal oxidative stress	Changes in seminal reactive oxygen species	Baseline to 12 months
Changes in sperm morphology	Changes in percent normal sperm morphology on semen analysis	Baseline to 12 months
Changes in seminal DNA fragmentation	Changes in seminal DNA fragmentation rate on semen analysis	Baseline to 12 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Scott Lundy, MD PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: IRB 16-721

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No