Clinical trial NCT05903859: Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
Official title: Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Infertility, Male
Keywords: Spinal cord injury
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-06-15
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Change in total motile sperm count
timeFrame: Baseline, up to 6 months post intervention, up to 6 months post follow up.
Secondary outcomes:
measure: Change in percentage sperm DNA fragmentation
timeFrame: Baseline, up to 6 months post intervention, up to 6 months post follow up.
measure: Change in percentage of sperm viability
timeFrame: Baseline, up to 6 months post intervention, up to 6 months post follow up.
measure: Change in semen inflammasome markers
timeFrame: Baseline, up to 6 months post intervention, up to 6 months post follow up.
measure: Number of treatment-related adverse events
timeFrame: Up to 6 months post follow up.
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Emad Ibrahim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ibrahim E, Aballa TC, Lynne CM, Brackett NL. Oral probenecid improves sperm motility in men with spinal cord injury. J Spinal Cord Med. 2018 Sep;41(5):567-570. doi: 10.1080/10790268.2017.1320875. Epub 2017 May 2.