Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 and up Men only

Improving sperm motility in men with spinal cord injuries

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

Run by University of Miami · NCT05903859 · Data updated 2026-11-12

This study is testing if a medication called probenecid can help improve sperm movement in men with spinal cord injuries who are struggling with infertility.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment90 (estimated)
SponsorUniversity of Miami
Academic / other
Drugs / interventionsmethotrexate
Locations1 site (Miami, Florida)
StatusRecruiting
StartedJanuary 18, 2024
Main results expectedMay 31, 2027
Study endsDecember 31, 2028
Registry record updatedMarch 2, 2026
Trial IDNCT05903859 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are men aged 18 and older who have experienced a traumatic spinal cord injury.

Probably not a fit

Patients who are azoospermic or have had their spinal cord injury for less than one year may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on addressing infertility in men who have sustained spinal cord injuries, a condition that often results in normal sperm counts but low sperm motility. The research will evaluate the effectiveness of probenecid, administered orally, in enhancing sperm motility among these men. Participants will be assigned to receive either probenecid at different dosages or a placebo to assess the drug's impact on reproductive function. The study aims to provide insights into potential treatments for infertility in this specific population.

Why it matters

Potential benefit: If successful, this study could lead to improved fertility options for men with spinal cord injuries.

How similar studies have gone: While there is limited data on the specific use of probenecid for this purpose, similar studies addressing male infertility in spinal cord injury patients have shown promise.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

1. Subject has been injured less than 1 year.
2. The subject is known to be azoospermic.
3. The subject has an indwelling urethral Foley catheter.
4. Subject is under the age of 18 years.
5. 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.
6. Subject is unable to consent or comprehend the procedures and their implications.
7. Subject has a permanent implanted electrical device, i.e., cardiac pacemaker, phrenic nerve stimulator, spinal cord stimulator, etc.
8. Any subject for whom the procedure or medication is otherwise contraindicated.
9. Subject has hypersensitivity to probenecid.
10. Subject has a history of uric acid kidney stones and/or peptic ulcer.
11. The subject has had a febrile Urinary Tract Infection (UTI) within the 2 months prior to enrollment.
12. The subject is taking methotrexate, aspirin, other salicylates, or anti-inflammatory medicines.
13. The subject has a history of Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Where it's running

  • University of Miami
    Miami, Florida, United States
    Recruiting

Study contacts

  • Principal investigator: Emad Ibrahim, MD — University of Miami
  • Study coordinator: Odaro Ugbo, BSc
  • Email: oxu32@miami.edu
  • Phone: 305-243-1491

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.