Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in total motile sperm count
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject has a traumatic spinal cord injury.
- •Subject is male and is 18 years or older.
排除标准
- •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.
研究组 & 干预措施
Full dose group
Participants in this group will receive the full dose of probenecid for a total of 90 days.
干预措施: Probenecid 500 Milligrams (mg) (Drug)
Half dose group
Participants in this group will receive half the dose of probenecid for a total of 90 days.
干预措施: probenecid 250 Milligrams (mg) (Drug)
Control-placebo group
Participants in this group will receive a placebo dose (No active ingredient) for a total of 90 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in total motile sperm count
时间窗: 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.
次要结局
- Change in percentage sperm DNA fragmentation(Baseline, up to 6 months post intervention, up to 6 months post follow up.)
- Change in percentage of sperm viability(Baseline, up to 6 months post intervention, up to 6 months post follow up.)
- Change in semen inflammasome markers(Baseline, up to 6 months post intervention, up to 6 months post follow up.)
- Number of treatment-related adverse events(Up to 6 months post follow up.)
研究者
Emad Ibrahim
Associate Professor
University of Miami