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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-SC220060 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| Congressionally Directed Medical Research Programs | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full dose group | Experimental | Participants in this group will receive the full dose of probenecid for a total of 90 days. |
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| Half dose group | Experimental | Participants in this group will receive half the dose of probenecid for a total of 90 days. |
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| Control-placebo group | Placebo Comparator | Participants in this group will receive a placebo dose (No active ingredient) for a total of 90 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probenecid 500 Milligrams (mg) | Drug | Participants in this group will receive 500 mg of probenecid by mouth twice a day for a total of 90 days. |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Odaro Ugbo, BSc | Contact | 305-243-1491 | oxu32@miami.edu | |
| Orrey Padilla | Contact | 305-243-1491 | oxp210@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Emad Ibrahim, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28464732 | Result | 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. |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| probenecid 250 Milligrams (mg) | Drug | Participants in this group will receive 250 mg of probenecid by mouth twice a day for a total of 90 days. |
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| Placebo | Drug | Participants in this group will receive a placebo pill by mouth twice a day for a total of 90 days. |
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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. |
| D052801 |
| Male Urogenital Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |