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Recruiting NCT05903859

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

Phase III Interventional Infertility, Male

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Probenecid 500 Milligrams (mg), probenecid 250 Milligrams (mg), Placebo.
Who it may be relevant to
Registry conditions: Infertility, Male. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Drug Probenecid 500 Milligrams (mg)
    Participants in this group will receive 500 mg of probenecid by mouth twice a day for a total of 90 days.
  • Drug probenecid 250 Milligrams (mg)
    Participants in this group will receive 250 mg of probenecid by mouth twice a day for a total of 90 days.
  • Drug Placebo
    Participants in this group will receive a placebo pill by mouth twice a day for a total of 90 days.

Primary outcome measures

  • Change in total motile sperm count [Time frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.]
Secondary outcome measures (4)
  • Change in percentage sperm DNA fragmentation [Time frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.]
  • Change in percentage of sperm viability [Time frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.]
  • Change in semen inflammasome markers [Time frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.]
  • Number of treatment-related adverse events [Time frame: Up to 6 months post follow up.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Miami

Publications

  • 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. PMID 28464732

Identifiers

NCT: NCT05903859 · 20230188 · CDMRP-SC220060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗