Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
ConditionInfertility, Male
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Miami
About this trial
This is a study of infertility which often occurs in men with spinal cord injury. Most men with spinal cord injury have a normal sperm count but abnormally low sperm motility - which means that the sperm does not swim well. This study will determine if a medicine given by mouth will improve sperm motility in men with spinal cord injuries. The medicine is called probenecid.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject has a traumatic spinal cord injury.
Subject is male and is 18 years or older.
Disqualifiers
Subject has been injured less than 1 year.
The subject is known to be azoospermic.
The subject has an indwelling urethral Foley catheter.
Subject is under the age of 18 years.
Trial design
Design model
Parallel
Treatments tested in this trial
Probenecid 500 Milligrams (mg)
DrugParticipants in this group will receive 500 mg of probenecid by mouth twice a day for a total of 90 days.
probenecid 250 Milligrams (mg)
DrugParticipants in this group will receive 250 mg of probenecid by mouth twice a day for a total of 90 days.
Placebo
DrugParticipants in this group will receive a placebo pill by mouth twice a day for a total of 90 days.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Full dose groupExperimental treatment 1 intervention
Group B: Half dose groupExperimental treatment 1 intervention
Group C: Control-placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in total motile sperm count
The total sperm count will be assessed by calculating semen volume times sperm count times sperm motility percentage.The unit of measurement is in Millions.
Time frame
Baseline, up to 6 months post intervention, up to 6 months post follow up.Secondary outcomes
1
Change in percentage sperm DNA fragmentation
The percentage of DNA fragmented sperm in specimen
Time frame
Baseline, up to 6 months post intervention, up to 6 months post follow up.2
Change in percentage of sperm viability
The percentage of viable sperm ion specimen
Time frame
Baseline, up to 6 months post intervention, up to 6 months post follow up.3
Change in semen inflammasome markers
Markers will be measured in picogram/milliliter units
Time frame
Baseline, up to 6 months post intervention, up to 6 months post follow up.4
Number of treatment-related adverse events
Treatment-related adverse events will be assessed by the treating physician using Common Terminology Criteria for Adverse Events 4 (CTCAE 4)
Time frame
Up to 6 months post follow up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov