INTRODUCTION
Finasteride is a specific and potent inhibitor of the type 2,
5α-reductase enzyme that inhibits the conversion of testosterone
to dihydrotestosterone.1 The US Food and Drug
Administration (FDA) approved finasteride's use in men with
androgenic alopecia (AGA) in December 1997, and currently, finasteride is widely utilized by dermatologists for the treatment
of this condition.2
Since 30% of men are affected by AGA by the age of 30 years3 and
finasteride influences the metabolism of androgens, concerns
have been raised about its adverse effects, especially in men of
reproductive age. A recent review including 9 randomized controlled
trials (n=3,570) has concluded that the only adverse effect
associated with finasteride therapy was erectile dysfunction (ED),
suggesting that 1 in every 80 patients treated will experience ED.4
Unfortunately, the studies included in this review did not consider
finasteride's effects on fertility. Only 2 randomized studies
have addressed this issue.5,6 Overstreet et al5 found that at the
FDA-approved dose for AGA (1 mg daily), finasteride does not adversely
affect sperm parameters. Instead, a significant influence
on motility was observed in a randomized controlled trial where
men received 5 mg of finasteride daily, the dose approved by the
FDA for the treatment of benign prostatic hyperplasia.6 However,
both studies involved potentially fertile men and did not provide
any data about finasteride's effects on conception. To date, no fullterm
pregnancy or live birth during use of or after cessation of
finasteride therapy has been documented.
We report the case of a patient who presented to our center
for primary infertility and demonstrated severe oligospermia.
The patient had taken finasteride for approximately 10 years.
We reviewed the literature on finasteride's effects on male
fertility, searching in the Ovid/Medline, PubMed, and Google
Scholar databases for all articles published in English, French,
German, and Italian between January 1950 and December
2011. The following terms were used: finasteride, male fertility,
infertility, spermatozoa, semen, and pregnancy. We also
reviewed all the references cited in those papers.
CASE REPORT
Approval to report this case was obtained from the institutional
review board of the Institute for Maternal and Child Health
IRCCS Burlo Garofolo in Trieste, Italy.
A couple presented to our Assisted Reproduction Unit for primary
infertility of 18 months' duration. The woman, aged 36
years, had no history of ovulation disorders, endometriosis,
pelvic inflammatory disease, pelvic surgery, or other conditions
potentially interfering with fertility. Her menstrual cycles were
regular. Pelvic examination and transvaginal ultrasound did not
reveal any pathology. The man, aged 37 years, was a nonsmoker
and nondrinker. He had no history of occupational exposure
to heat, radiation, or chemicals. He had previously undergone
surgery for hiatal hernia repair as well as saphenectomy. He
was being treated with 15 mg of oral lansoprazole daily for a
