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

Infertility, Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05903859
• Other study ID #: 20230188
• Secondary ID: SC220060
• Status: Recruiting
• Phase: Phase 3
• Start date: January 18, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: January 2024
• Source: University of Miami
• Contact: Odaro Ugbo, BSc
• Phone: 305-243-1491
• Email: oxu32[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2028
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject has a traumatic spinal cord injury.

2. Subject is male and is 18 years or older.

Exclusion Criteria:

1. Subject has been injured less than 1 year.

2. The subject is known to be azoospermic.

3. The subject has an indwelling urethral Foley catheter.

4. Subject is under the age of 18 years.

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. Subject is unable to consent or comprehend the procedures and their implications.

7. Subject has a permanent implanted electrical device, i.e., cardiac pacemaker, phrenic nerve stimulator, spinal cord stimulator, etc.

8. Any subject for whom the procedure or medication is otherwise contraindicated.

9. Subject has hypersensitivity to probenecid.

10. Subject has a history of uric acid kidney stones and/or peptic ulcer.

11. The subject has had a febrile Urinary Tract Infection (UTI) within the 2 months prior to enrollment.

12. The subject is taking methotrexate, aspirin, other salicylates, or anti-inflammatory medicines.

13. The subject has a history of Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Spinal Cord Injuries

Intervention

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

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.