Amory · The Journal of clinical endocrinology and metabolism 2007 · randomized controlled trial · n=99

The effect of 5alpha-reductase inhibition with dutasteride and finasteride on semen parameters and serum hormones in healthy men.

Cited 245 times in the scientific literature.

Level 2 - randomized trial

Individual randomized controlled trial

PubMed 17299062 · doi:10.1210/jc.2006-2203 · record verified 2026-08-29

What was done

In a double-blind, placebo-controlled randomized trial, 99 healthy men were assigned to receive dutasteride 0.5 mg daily (n = 33), finasteride 5 mg daily (n = 34), or placebo (n = 32) for 52 weeks, followed by a 24-week untreated follow-up period. Blood and semen samples collected at baseline, 26 weeks, 52 weeks, and 24 weeks post-treatment were evaluated for testosterone, dihydrotestosterone (DHT), total sperm count, sperm concentration, semen volume, motility, and morphology.

What was found

Dutasteride and finasteride significantly suppressed serum DHT compared with placebo (dutasteride: -94%; finasteride: -73%; P < 0.001) and transiently increased serum testosterone. Total sperm count compared to baseline significantly decreased at 26 weeks (dutasteride: -28.6%; finasteride: -34.3%), but reductions were not statistically significant at 52 weeks (dutasteride: -24.9%; finasteride: -16.2%) or at 24-week follow-up (dutasteride: -23.3%; finasteride: -6.2%). At 52 weeks, semen volume was decreased (dutasteride: -29.7%, significant; finasteride: -14.5%, not significant) and sperm concentration showed non-significant decreases (dutasteride: -3.2%; finasteride: -7.4%). Both treatments caused a significant 6% to 12% reduction in sperm motility during treatment and at follow-up. Neither drug affected sperm morphology.

Why it matters

This study provides randomized evidence that 5alpha-reductase inhibition causes mild, largely reversible declines in sperm count, semen volume, and motility in healthy men without altering sperm morphology.

Limits

The study had a modest sample size (n = 99 across three arms) and evaluated only healthy men, limiting generalizability to men with pre-existing subfertility or oligospermia. Actual clinical fertility and pregnancy rates were not assessed, and sperm motility remained reduced through the 24-week recovery period.

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