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

Launched by UNIVERSITY OF MIAMI · Jun 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for infertility in men who have experienced a spinal cord injury. Many of these men have normal sperm counts, but their sperm often struggles to swim effectively, which makes it harder to conceive a child. The researchers are testing a medicine called probenecid, taken by mouth, to see if it can help improve the swimming ability of sperm in these men.

To be eligible for this study, participants must be male, at least 18 years old, and have a traumatic spinal cord injury. However, those who have had their injury for less than a year or have certain medical conditions that could complicate the study, such as severe illnesses or specific medications, will not be able to participate. If you join the trial, you will take the medication and be monitored to see if it helps improve your sperm motility. This study aims to provide valuable information that could assist men with spinal cord injuries who want to start a family.

Gender

MALE

Eligibility 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.