Impact of prednisone on vasectomy reversal outcomes (iPRED study): results from a randomized, controlled clinical trial

Objective: To evaluate the safety and efficacy of prednisone on pregnancy rates and semen concentrations at 1 year after vasectomy reversal.

Design: Randomized, controlled trial (NCT04788823).

Setting: Single medical center specializing in vasectomy reversals.

Patient(s): Men undergoing vasectomy reversal.

Intervention(s): Participants were randomly assigned 1:1:1:1 to Control (no prednisone), Pred High (20 mg prednisone taper, every other month × 3 months), Pred PRN (20 mg prednisone taper × 3 courses maximum if sperm counts were declining or 0), and Pred Low (5 mg/d, every other week × 6 months). Note that Pred High and Pred PRN were stopped prematurely due to interim findings demonstrating lower pregnancy rates.

Main outcome measure(s): Pregnancy rates, semen concentrations, and adverse events. The current study reports outcomes at 1 year.

Result(s): A total of 75 men were enrolled, with 1-year data available in 73 (Control, n = 25; Pred High, n = 14; Pred PRN, n = 11; and Pred Low, n = 23). Baseline factors were similar among cohorts. Pregnancy rates at 12 months were higher in Controls (65%) and Pred Low (67%) compared with Pred High (17%) and Pred PRN (38%). Overall patency at 12 months (sperm at any point) was 99%, with no statistically significant differences noted between groups for patency, median concentrations by month (range, 3-42), or overall median concentrations (median of medians range, 5-16).

Conclusion(s): High-dose (20 mg) prednisone results in decreased pregnancy rates after vasectomy reversal, an effect which is independent of sperm concentration, dose dependent, and persists for months after discontinuation. Prednisone doses (ranging from 5 to 20 mg) do not impact sperm concentrations.

Clinical trial registration number: NCT04788823 (https://clinicaltrials.gov/study/NCT04788823?term=NCT04788823&rank=1).