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

Study Overview
=================
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.

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

Conditions
-----------------
Infertility, Male

Intervention / Treatment
-----------------
* Drug: Probenecid 500 Milligrams (mg)
* Drug: probenecid 250 Milligrams (mg)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a traumatic spinal cord injury. Subject is male and is 18 years or older. Exclusion Criteria: Subject has been injured less than 1 year. The subject is known to be azoospermic. The subject has an indwelling urethral Foley catheter. Subject is under the age of 18 years. 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. Subject is unable to consent or comprehend the procedures and their implications. Subject has a permanent implanted electrical device, i.e., cardiac pacemaker, phrenic nerve stimulator, spinal cord stimulator, etc. Any subject for whom the procedure or medication is otherwise contraindicated. Subject has hypersensitivity to probenecid. Subject has a history of uric acid kidney stones and/or peptic ulcer. The subject has had a febrile Urinary Tract Infection (UTI) within the 2 months prior to enrollment. The subject is taking methotrexate, aspirin, other salicylates, or anti-inflammatory medicines. The subject has a history of Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full dose group<br>Participants in this group will receive the full dose of probenecid for a total of 90 days. | Drug: Probenecid 500 Milligrams (mg)<br>* Participants in this group will receive 500 mg of probenecid by mouth twice a day for a total of 90 days.<br>|
| Experimental: Half dose group<br>Participants in this group will receive half the dose of probenecid for a total of 90 days. | Drug: probenecid 250 Milligrams (mg)<br>* Participants in this group will receive 250 mg of probenecid by mouth twice a day for a total of 90 days.<br>|
| Placebo Comparator: Control-placebo group<br>Participants in this group will receive a placebo dose (No active ingredient) for a total of 90 days. | Drug: Placebo<br>* Participants in this group will receive a placebo pill by mouth twice a day for a total of 90 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total motile sperm count | 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. | Baseline, up to 6 months post intervention, up to 6 months post follow up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percentage sperm DNA fragmentation | The percentage of DNA fragmented sperm in specimen | Baseline, up to 6 months post intervention, up to 6 months post follow up. | 
| Change in percentage of sperm viability | The percentage of viable sperm ion specimen | Baseline, up to 6 months post intervention, up to 6 months post follow up. | 
| Change in semen inflammasome markers | Markers will be measured in picogram/milliliter units | Baseline, up to 6 months post intervention, up to 6 months post follow up. | 
| Number of treatment-related adverse events | Treatment-related adverse events will be assessed by the treating physician using Common Terminology Criteria for Adverse Events 4 (CTCAE 4) | Up to 6 months post follow up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal cord injury