Prednisone for Vasectomy Reversal Outcomes

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

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

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

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

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

I am between 18 and 65 years old.

My partner is under 36 years old.

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

+4 more

Exclusion Criteria

I have had a vasectomy reversal.

I am currently taking corticosteroids.

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

+7 more

Participant Groups

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.

4Treatment groups

Experimental Treatment

Active Control

Group I: Prednisone Monthly - ScheduledExperimental Treatment1 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 NeededExperimental Treatment1 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 WeekExperimental Treatment1 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: ControlActive Control1 Intervention

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