Retrograde Ejaculation and Sexual Dysfunction in Men With Diabetes Mellitus
October 3, 2016 updated by: Jens Fedder, Odense University Hospital
Diabetic men and controls are examined for retrograde ejaculation, and erectile dysfunction is registered with a validated questionaire (International Index of Erectile Function-15).
Concentration, total number of sperm and motility is determined in freshly delivered ejaculates and postejaculatory urine.
Our hypothetis is that diabetics exhibit significantly higher rate of retrograde ejaculation than healthy controls.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Odense, Denmark, 5000
- Fertility Clinic, Odense University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
26 years to 51 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Diabetic men and non-diabetic men in Denmark.
Description
Inclusion Criteria:
- Men 30-55 years of age
- Men registered in a Diabetic Biobank including 6000 diabetics and 6000 controls
Exclusion Criteria:
- Men who do not understand Danish
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Diabetic men
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Non-diabetic men
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Retrograde ejaculation (a minimum of a total of 1 million sperm in postejaculatory urine)
Time Frame: The examination program for each patient was finished within one day.
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The examination program for each patient was finished within one day.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Erectile dysfunction
Time Frame: The examination program (including a questionaire on erectile dysfunction) for each patient was finished within one day.
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The examination program (including a questionaire on erectile dysfunction) for each patient was finished within one day.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
November 27, 2012
First Submitted That Met QC Criteria
December 4, 2012
First Posted (Estimate)
December 6, 2012
Study Record Updates
Last Update Posted (Estimate)
October 4, 2016
Last Update Submitted That Met QC Criteria
October 3, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lab.Reprod.Biol.-Horsens-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.