Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05903859

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Infertility, Male Central Nervous System Diseases Genital Diseases Genital Diseases, Male Infertility Male Urogenital Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Urogenital Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Emad Ibrahim, MD

PRINCIPAL_INVESTIGATOR

Orrey Padilla

CONTACT

[email protected]

305-243-1491

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Placebo

Drug

Participants in this group will receive a placebo pill by mouth twice a day for a total of 90 days.

Primary outcomes

  1. Change in total motile sperm count

    Time frame: 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 outcomes

  1. Change in percentage sperm DNA fragmentation

    Time frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.

    The percentage of DNA fragmented sperm in specimen

  2. Change in percentage of sperm viability

    Time frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.

    The percentage of viable sperm ion specimen

  3. Change in semen inflammasome markers

    Time frame: Baseline, up to 6 months post intervention, up to 6 months post follow up.

    Markers will be measured in picogram/milliliter units

  4. Number of treatment-related adverse events

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Odaro Ugbo, BSc

CONTACT

[email protected]

305-243-1491

Orrey Padilla

CONTACT

[email protected]

305-243-1491

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jun 15, 2023
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.