Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04788823 |
| Other study ID # |
CUREPD 102 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
February 24, 2021 |
| Est. completion date |
February 2026 |
Study information
| Verified date |
September 2023 |
| Source |
Charitable Union for the Research and Education of Peyronie's Disease |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
1. Determine impact of prednisone on semen parameters post vasectomy reversal (evaluated
both using prednisone as a combined cohort as well as via 3 separate protocols).
2. Determine impact of prednisone on pregnancy rates post vasectomy reversal (evaluated
both using prednisone as a combined cohort as well as via 3 separate protocols).
3. Assess adverse events with prednisone utilization
Description:
1. Introduction
This document is a protocol for a randomized, controlled clinical trial. This study will be
carried out in accordance with the procedures described in this protocol, applicable United
States government regulations and Western International Review Board policies and procedures.
1.1 Background and Clinical Need for the Current Study
Currently, vasectomy reversals are a common surgical treatment performed to restore fertility
in men who have previously undergone vasectomies. Post-operatively, sperm are seen in the
ejaculate in the majority of men undergoing a reversal, however, sperm counts commonly
fluctuate over time. In a percentage of men, counts will ultimately decline to 0 over time.
Although the exact cause of this decline is unknown, it is felt to be secondary to tissue
remodeling and/or inflammation leading to stenosis of the anastomotic repair. To address this
issue, clinicians have used prednisone for several decades. Despite the long-standing use,
very few publications have assessed the overall efficacy of this therapy on improving
outcomes. The objective of the current study is to perform a much more robust assessment as
to the true risks and benefits of this therapy in improving post-operative outcomes.
1.2 Investigational Treatments
Men who are post vasectomy reversal will be treated with either no therapy (control) or one
of three separate protocols with prednisone.
1.3 Preliminary Data
A very limited amount of data exists regarding the efficacy of corticosteroids in improving
outcomes post vasectomy reversal. The earliest known study involved the use of cortisone in 8
dogs who underwent vasovasostomy procedures. Results showed that 63% of vasa were patent in
the steroid group compared to 43% in control animals (not statistically significant). A
second study administered prednisone to 20 men post vasectomy reversal and compared against
20 men who had previously undergone reversal but were not treated with prednisone. Results
showed improved sperm counts (statistically significant) without statistically significant
differences in pregnancy rates. And finally, a third study performed a retrospective analysis
in 89 men who underwent reversals over a period of 11 years. Results demonstrated increases
in total motile sperm counts, with greater improvements noted among men who exhibited the
presence of sperm at the time of prednisone administration compared to those with 0 sperm.
These data are limited by several factors. The first study listed also performed a pathologic
analysis and failed to demonstrate any differences in the extent of fibrosis. The second
study was performed in a sequential manner, where outcomes may have just been reflective of
learning curve improvements, and improvements were no longer present after the steroid was
discontinued. The third study was retrospective in nature, and therefore is limited by
significant biases (i.e. only men with low counts received the treatment, which leads to an
effect bias). All series were very small and lacked statistical power.
Despite these limited data, the use of prednisone post vasectomy reversal is a common,
widespread practice among reversal surgeons.
1.4 Study Rationale and Risk Analysis (Risks to Benefits Ratio)
The study is currently designed to address an important clinical question. Specifically, does
the addition of prednisone post-operatively lead to improved semen and pregnancy outcomes.
Additionally, does the addition of prednisone lead to temporary or permanent improvements.
Regarding potential risks, the use of prednisone will be limited to shorter durations of
therapy. Potential risks in a young, healthy population are low. Specifically, an analysis of
men 20-64 found that the risks of prednisone include 3 GI bleeds per 100 person years, <1
with a severe infection, and <1 with heart failure. Our study will not include as high of a
dosage or duration of therapy shown in this prior risk study, and as such, the true risks are
anticipated to be small (if any).
