Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
25 participants
OBSERVATIONAL
2018-11-01
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bariatric Surgery and Sperm Quality
NCT01842295
Impact of Weight Loss Induced by Bariatric Surgery or Nutritional Management on Sexual Function in Men With Severe Obesity
NCT03528980
The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition
NCT00686972
Bariatric Surgery and Male Reproductive Function
NCT04237311
Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes
NCT01278823
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Semen Analysis
Sperm counts will be determined by semen analysis.
Hormonal panel
Blood test for LH, FSH, testosterone, and estradiol
RYGB Gastric Bypass
Roux-en-Y Gastric Bypass
IIEF Survey
International Index of Erectile Function is a validated 5-question survey examining sexual health in men
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Semen Analysis
Sperm counts will be determined by semen analysis.
Hormonal panel
Blood test for LH, FSH, testosterone, and estradiol
RYGB Gastric Bypass
Roux-en-Y Gastric Bypass
IIEF Survey
International Index of Erectile Function is a validated 5-question survey examining sexual health in men
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Undergoing Roux-en-Y bariatric surgery
Exclusion Criteria
* Prior scrotal surgery
* Known karyotypic abnormalities
18 Years
55 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Cleveland Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Scott Lundy
Resident Physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Scott Lundy, MD PhD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB 16-721
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.