Bariatric Surgery CandidateNCT03725696
The Effect of Bariatric Surgery on Spermatogenesis
An observational study of Bariatric Surgery Candidate and Sexual Function and Fertility Disorders, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Bariatric Surgery Candidate, Sexual Function and Fertility Disorders
- What is being tested?
- Semen Analysis, Hormonal panel and RYGB Gastric Bypass
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Men aged 18-55
- Undergoing Roux-en-Y bariatric surgery
Who cannot join
- History of undescended testes
- Prior scrotal surgery
- Known karyotypic abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Semen Analysis, Hormonal panel, RYGB Gastric Bypass, IIEF Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semen AnalysisDiagnostic test
Sperm counts will be determined by semen analysis.
Hormonal panelDiagnostic test
Blood test for LH, FSH, testosterone, and estradiol
RYGB Gastric BypassProcedure or surgery
Roux-en-Y Gastric Bypass
IIEF SurveyDiagnostic test
International Index of Erectile Function is a validated 5-question survey examining sexual health in men
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Semen Analysis; Diagnostic Test: Hormonal panel; Procedure: RYGB Gastric Bypass; Diagnostic Test: IIEF Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sperm concentration
Changes in sperm concentration on semen analysis
Measured: Baseline to 12 months
Secondary outcomes (6)
Weight loss
Change in weight following bariatric surgery
Measured: 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).
Measured: Baseline to 12 months
Changes in reproductive hormones
Changes in FSH, LH, testosterone, and estrogen blood levels
Measured: Baseline to 12 months
Changes in seminal oxidative stress
Changes in seminal reactive oxygen species
Measured: Baseline to 12 months
Changes in sperm morphology
Changes in percent normal sperm morphology on semen analysis
Measured: Baseline to 12 months
Changes in seminal DNA fragmentation
Changes in seminal DNA fragmentation rate on semen analysis
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 Nov 2018
- Primary completion31 Jul 2019
- Study completion31 Dec 2020
Why it stopped: •Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Lundy, The Cleveland Clinic
- Investigators
- Scott Lundy, MD PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725696
- Sponsor's protocol ID
- IRB 16-721
- Status last verified
- Apr 2021
- First submitted
- 24 Oct 2018
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bariatric Surgery on Spermatogenesis
- ClinicalTrials.gov ID
- NCT03725696
- Acronym / sponsor ID
- IRB 16-721
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: •Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Diagnostic Test: Semen Analysis, Diagnostic Test: Hormonal panel, Procedure: RYGB Gastric Bypass, Diagnostic Test: IIEF SurveyPatients 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Men aged 18-55
- Undergoing Roux-en-Y bariatric surgery
Key exclusion criteria (3 listed)
- History of undescended testes
- Prior scrotal surgery
- Known karyotypic abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semen AnalysisSperm counts will be determined by semen analysis. | Diagnostic test | Observational group |
| Hormonal panelBlood test for LH, FSH, testosterone, and estradiol | Diagnostic test | Observational group |
| RYGB Gastric BypassRoux-en-Y Gastric Bypass | Procedure or surgery | Observational group |
| IIEF SurveyInternational Index of Erectile Function is a validated 5-question survey examining sexual health in men | Diagnostic test | Observational group |
Primary outcome
Changes in sperm concentration
Time frame: Baseline to 12 months
Changes in sperm concentration on semen analysis
6 secondary outcomes
Weight loss
Time frame: Baseline to 12 months
Changes in sexual health
Time frame: Baseline to 12 months
Changes in reproductive hormones
Time frame: Baseline to 12 months
Changes in seminal oxidative stress
Time frame: Baseline to 12 months
Changes in sperm morphology
Time frame: Baseline to 12 months
Changes in seminal DNA fragmentation
Time frame: Baseline to 12 months
Results and safety
The study was stopped early (reason given: •Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Lundy, MD PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and Sexual Function and Fertility Disorders, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: •Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sperm concentration (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.