RECRUITING

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

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Conditions

Infertility, MaleSpinal cord injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2024-01-18
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05903859

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject has a traumatic spinal cord injury.
  2. 2. Subject is male and is 18 years or older.
  1. 1. Subject has been injured less than 1 year.
  2. 2. The subject is known to be azoospermic.
  3. 3. The subject has an indwelling urethral Foley catheter.
  4. 4. Subject is under the age of 18 years.
  5. 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. 6. Subject is unable to consent or comprehend the procedures and their implications.
  7. 7. Subject has a permanent implanted electrical device, i.e., cardiac pacemaker, phrenic nerve stimulator, spinal cord stimulator, etc.
  8. 8. Any subject for whom the procedure or medication is otherwise contraindicated.
  9. 9. Subject has hypersensitivity to probenecid.
  10. 10. Subject has a history of uric acid kidney stones and/or peptic ulcer.
  11. 11. The subject has had a febrile Urinary Tract Infection (UTI) within the 2 months prior to enrollment.
  12. 12. The subject is taking methotrexate, aspirin, other salicylates, or anti-inflammatory medicines.
  13. 13. The subject has a history of Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Contacts and Locations

Study Contact

Odaro Ugbo, BSc
CONTACT
305-243-1491
oxu32@miami.edu
Orrey Padilla
CONTACT
305-243-1491
oxp210@med.miami.edu

Principal Investigator

Emad Ibrahim, MD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Emad Ibrahim, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-18
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2024-01-18
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • Spinal cord injury

Additional Relevant MeSH Terms

  • Infertility, Male