RecruitingPhase 3

Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)

United States90 participantsStarted 2024-01-18

Plain-language summary

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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Subject has a traumatic spinal cord injury.
✓. Subject is male and is 18 years or older.

Exclusion criteria

✕. 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.
✕. Subject has an unstable medical condition including, but not limited to, Crohn's disease, ulcerative colitis, colon cancer or has other conditions deemed to be exclusionary per the Investigator.
✕. Subject is unable to consent or comprehend the procedures and their implications.
✕. Subject has a permanent implanted electrical device, i.e., cardiac pacemaker, phrenic nerve stimulator, spinal cord stimulator, etc.
✕. Any subject for whom the procedure or medication is otherwise contraindicated.

What they're measuring

Change in total motile sperm count

Timeframe: Baseline, up to 6 months post intervention, up to 6 months post follow up.

Trial details

NCT IDNCT05903859

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-31

Contact for this trial

Odaro Ugbo, BSc

305-243-1491 oxu32@miami.edu

View on ClinicalTrials.gov More Infertility, Male trials