Prednisone for Vasectomy Reversal Outcomes

Overseen By Holli Burgon

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Charitable Union for the Research and Education of Peyronie's Disease

Must not be taking: Corticosteroids, Testosterone

Disqualifiers: Diabetes, Hypertension, Renal insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the drug Prednisone for vasectomy reversal outcomes?

One study suggests that Prednisone, a corticosteroid, may improve semen quality after vasectomy reversal, although data is limited and more research is needed to confirm its effectiveness. ^{1 2 3 4 5}

Is prednisone safe for use in humans?

Prednisone is a corticosteroid that has been commonly used in various medical treatments, and while specific safety data for its use after vasectomy reversal is limited, it is generally considered safe for human use when prescribed by a doctor. ^{1 2 4 5 6}

How does the drug prednisone improve vasectomy reversal outcomes?

Prednisone, a corticosteroid, may help improve semen parameters after vasectomy reversal by reducing inflammation and swelling, which can contribute to partial or complete blockage of the reconnected vas deferens (the tube that carries sperm). This approach is unique because it targets the inflammatory response, which is not typically addressed by other treatments for vasectomy reversal. ^{1 2 4 7 8}

Research Team

Benjamin Green

Principal Investigator

The Male Fertility and Peyronie's Clinic

Eligibility Criteria

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

My partner is under 36 years old.

The participant's partner does not have any known problems with fertility.

I am a man planning my first vasectomy reversal at the Male Fertility and Peyronie's Clinic.

Exclusion Criteria

I have had a vasectomy reversal.

I am currently taking corticosteroids.

I have had a fungal infection that spread throughout my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive prednisone treatment according to one of three protocols or no treatment for up to 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

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.

Participant Groups

Group I: Prednisone Monthly - Scheduled Experimental Treatment 1 Intervention

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 II: Prednisone Monthly - As Needed Experimental Treatment 1 Intervention

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 III: Prednisone Every Other Week Experimental Treatment 1 Intervention

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 IV: Control Active Control 1 Intervention

Group 1 will represent controls and will not receive prednisone in the 3-year post-op period.

Who Is Running the Clinical Trial?

Charitable Union for the Research and Education of Peyronie's Disease

Lead Sponsor

Trials

6

Recruited

920+

References

1. Canada pubmed.ncbi.nlm.nih.gov

Prednisone after vasectomy reversal may improve semen parameters: one institution's experience. [2021]

2. Singapore pubmed.ncbi.nlm.nih.gov

Impact of surgical volume and resident involvement on patency rates after vasectomy reversal-A 14-year experience in an open access system. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[Efficacy of microsurgical vasectomy reversal on patients after vasectomy]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Vasectomy reversal outcomes in men previously on testosterone supplementation therapy. [2015]

5. Brazil pubmed.ncbi.nlm.nih.gov

Portable model for vasectomy reversal training. [2020]

6. China pubmed.ncbi.nlm.nih.gov

Vasectomy reversal: a clinical update. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Practice patterns in vasectomy reversal surgery: results of a questionnaire study among practicing urologists. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Factors predicting successful microsurgical vasectomy reversal. [2009]