Infertility, Male
Conditions
Keywords
Spinal cord injury
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.
Interventions
DRUGProbenecid 500 Milligrams (mg)
Participants in this group will receive 500 mg of probenecid by mouth twice a day for a total of 90 days.
DRUGprobenecid 250 Milligrams (mg)
Participants in this group will receive 250 mg of probenecid by mouth twice a day for a total of 90 days.
DRUGPlacebo
Participants in this group will receive a placebo pill by mouth twice a day for a total of 90 days.
Sponsors
University of Miami
Congressionally Directed Medical Research Programs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in total motile sperm count | Baseline, up to 6 months post intervention, up to 6 months post follow up. | The total sperm count will be assessed by calculating semen volume times sperm count times sperm motility percentage.The unit of measurement is in Millions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in percentage sperm DNA fragmentation | Baseline, up to 6 months post intervention, up to 6 months post follow up. | The percentage of DNA fragmented sperm in specimen |
| Change in percentage of sperm viability | Baseline, up to 6 months post intervention, up to 6 months post follow up. | The percentage of viable sperm ion specimen |
| Change in semen inflammasome markers | Baseline, up to 6 months post intervention, up to 6 months post follow up. | Markers will be measured in picogram/milliliter units |
| Number of treatment-related adverse events | Up to 6 months post follow up. | Treatment-related adverse events will be assessed by the treating physician using Common Terminology Criteria for Adverse Events 4 (CTCAE 4) |
Countries
United States
Contacts
CONTACTOdaro Ugbo, BSc
CONTACTOrrey Padilla
PRINCIPAL_INVESTIGATOREmad Ibrahim, MD
University of Miami
Outcome results
None listed