NCT03725696

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

9 months

First QC Date

October 24, 2018

Last Update Submit

April 7, 2021

Conditions

Bariatric Surgery CandidateSexual Function and Fertility Disorders

Outcome Measures

Primary Outcomes (1)

  • Changes in sperm concentration

    Changes in sperm concentration on semen analysis

    Baseline to 12 months

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

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 AnalysisDiagnostic Test: Hormonal panelProcedure: RYGB Gastric BypassDiagnostic Test: IIEF Survey

Interventions

Semen AnalysisDIAGNOSTIC_TEST

Sperm counts will be determined by semen analysis.

Observational group
Hormonal panelDIAGNOSTIC_TEST

Blood test for LH, FSH, testosterone, and estradiol

Observational group
RYGB Gastric BypassPROCEDURE

Roux-en-Y Gastric Bypass

Observational group
IIEF SurveyDIAGNOSTIC_TEST

International Index of Erectile Function is a validated 5-question survey examining sexual health in men

Observational group

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Semen Analysis

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Scott Lundy, MD PhD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

October 24, 2018

First Posted

October 31, 2018

Study Start

November 1, 2018

Primary Completion

July 31, 2019

Study Completion

December 31, 2020

Last Updated

April 9, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)