Prednisone for Vasectomy Reversal Outcomes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether prednisone, a type of medication, can improve semen quality and increase pregnancy rates after a vasectomy reversal. It compares different methods of using prednisone to determine the most effective approach, while also monitoring for side effects. Men who have undergone a vasectomy reversal for the first time and wish to restore fertility with their partner may be suitable candidates for this study. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using corticosteroids or have used testosterone within the past year.
What is the safety track record for prednisone?
Research shows that prednisone is generally safe to use. It has improved sperm counts after vasectomy reversal, potentially increasing pregnancy chances. However, some studies noted that higher doses might lower pregnancy rates, so finding the right dose is important.
Prednisone, a well-known medication for various health issues, is usually well-tolerated. Like any medication, it can have side effects. Common ones include mood changes, increased appetite, and trouble sleeping. Most people do not experience severe side effects, especially with the lower doses often used in these studies.
Overall, prednisone has been used safely for many years, and the doses in these trials are similar to those in past research. This suggests that most participants should tolerate the treatment well.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about using prednisone for improving vasectomy reversal outcomes because it offers a novel approach by potentially reducing inflammation and improving sperm recovery. Unlike other treatments that may not specifically address the inflammatory response after surgery, prednisone is a corticosteroid that directly targets inflammation, which could be a key factor in enhancing fertility restoration. The trial explores different dosing strategies: one group takes prednisone every other week, another receives it monthly based on semen analysis results, and a third group follows a scheduled monthly regimen. These varied dosing plans might provide flexibility and effectiveness tailored to individual needs, potentially leading to better patient outcomes.
What evidence suggests that this trial's treatments could be effective for vasectomy reversal outcomes?
Research has shown that prednisone might influence the success of vasectomy reversals in various ways. Some studies suggest that high doses of prednisone can reduce the chances of pregnancy after the procedure. However, another study found that prednisone can increase sperm counts, although this did not necessarily lead to more pregnancies. Overall, results are mixed, with improvements in sperm counts but not in pregnancy rates. In this trial, participants will join different groups; some will receive prednisone in varying dosages and schedules, while others will not. Those considering participation should consider these findings regarding prednisone's possible effects.12467
Who Is on the Research Team?
Benjamin Green
Principal Investigator
The Male Fertility and Peyronie's Clinic
Are You a Good Fit for This Trial?
This trial is for men aged 18-65 who want to restore fertility after a vasectomy, have previously fathered a child, and are undergoing their first vasectomy reversal. Their partner must be under 36 with no known fertility issues and not on birth control recently. Men can't join if they've had chemotherapy, testosterone use within the last year, kidney problems, diabetes, high blood pressure or only one testicle.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive prednisone treatment according to one of three protocols or no treatment for up to 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Prednisone
Trial Overview
The study is looking at how prednisone affects sperm count and quality after a man has his vasectomy reversed. It also aims to see if prednisone changes the chances of getting pregnant post-reversal. The effects will be studied across different ways of using prednisone.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Group 2 will receive 3, one-month courses of prednisone (20 mg daily x 1 week, 10 mg daily x 1 week, 5 mg x 2 weeks). These will be given at the beginning of months 0, 2, and 4 and will be self-administered.
Group 3 will receive a maximum of 3, one-month courses of prednisone (20 mg daily x 1 week, 10 mg daily x 1 week, 5 mg x 2 weeks). These will be administered based on sequential semen analyses. If a semen analysis demonstrates a drop in concentration from a prior analysis or if it shows a 0 concentration, the course will be administered.
Group 4 will receive alternating 1 week dosages of prednisone (1 week on, 1 week off - 5 mg daily only) for a total of 24 weeks
Group 1 will represent controls and will not receive prednisone in the 3-year post-op period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Charitable Union for the Research and Education of Peyronie's Disease
Lead Sponsor
Citations
Impact of prednisone on vasectomy reversal outcomes ...
High-dose (20 mg) prednisone results in decreased pregnancy rates after vasectomy reversal, an effect which is independent of sperm concentration, dose ...
Impact of prednisone on vasectomy reversal outcomes ...
High-dose (20 mg) prednisone results in decreased pregnancy rates after vasectomy reversal, an effect which is independent of sperm concentration, dose ...
The Impact of Prednisone on Semen Parameters and ...
Results showed improved sperm counts (statistically significant) without statistically significant differences in pregnancy rates. And finally, a third study ...
Impact of prednisone on vasectomy reversal outcomes ...
High-dose (20 mg) prednisone results in decreased pregnancy rates after vasectomy reversal, an effect which is independent of sperm concentration, dose ...
RESULTS FROM A RANDOMIZED, CONTROLLED TRIAL
CONCLUSIONS: Prednisone taper protocols appear to reduce the likelihood for pregnancy following vasectomy reversal. Use of low-dose prednisone ...
(074) Safety and Efficacy Varying Doses of Prednisone Post ...
Prednisone taper protocols appear to reduce the likelihood for pregnancy following vasectomy reversal. Use of low-dose prednisone results in non-statistically ...
Prednisone after vasectomy reversal may improve semen ...
Our results demonstrate that prednisone is safe and may be effective in improving semen parameters after vasectomy reversal in men with suspected scarring or.
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