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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 90 (estimated) |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | January 18, 2024 |
| Main results expected | May 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | March 2, 2026 |
| Trial ID | NCT05903859 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
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.