Finasteride and Fertility: Case Report and Review of the Literature

December 2012 | Volume 11 | Issue 12 | Case Reports | 1511 | Copyright © December 2012

Giuseppe Ricci MD, Monica Martinelli BS, Stefania Luppi PhD, Leila Lo Bello MD, Michela De Santis MD,Kristina Skerk MD, and Gabriella Zito MD

Abstract
Although millions of men have taken or are taking finasteride, there are no documented cases of successful pregnancy in the literature after discontinuation of the drug. Early studies did not show significant influence of finasteride on semen parameters, whereas some recent observations have suggested that in subfertile patients, the effects of the drug might be amplified. Therefore, counseling is particularly difficult for men taking finasteride and planning pregnancy. We report the case of a couple whose male partner had used finasteride for approximately 10 years and who presented for primary infertility. The first semen analysis, carried out 3 months after finasteride cessation, revealed severe oligospermia. One month later, sperm concentration increased, and the following month, the couple spontaneously conceived. A healthy baby was delivered at full term. To the best of our knowledge, this is the first case of successful full-term pregnancy and live birth after long-term use of finasteride, which suggests that treatment with finasteride, even after several years, does not prevent normal conception. However, caution should be advised with the use of finasteride in male partners of couples who are attempting to become pregnant.

J Drugs Dermatol. 2012;11(12):1511-1513.

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