Improving sperm motility in men with spinal cord injuries
Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
PHASE3 · University of Miami · NCT05903859
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 | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Miami (other) |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT05903859 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 18 and older who have experienced a traumatic spinal cord injury.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Miami, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infertility, Male, Spinal cord injury