Healthy Clinical Trial
Official title:
Effect of Selective Serotonin Reuptake Inhibitor Antidepressants on Semen Parameters
According to the National Institute of Mental Health, depressive disorders afflict over six
million U.S. men annually. Most cases of moderate or severe depression are treated with
antidepressants, including monoamine oxidase inhibitors, tricyclic antidepressants, and,
more recently, selective serotonin reuptake inhibitors (SSRIs) and antidepressants with
modest serotonin and norepinephrine reuptake inhibition but unknown mechanism-of-action.
Over the past two years, prescribing data show a steady increase in antidepressant
dispensing rates (especially including serotonin reuptake inhibitors) for adults. SSRIs are
known to have an effect on ejaculatory function and are therapeutically used for treatment
of premature (rapid) ejaculation. However, few studies have evaluated the potential impact
of antidepressant medications on male fertility, and no studies have been published with
respect to the impact of newer antidepressants, such as SSRIs, on male fertility. In the
high-volume male infertility practice at New York Hospital-Cornell Medical Center, several
patients have presented who have had a clear temporal association between SSRI use and
impairment in sperm motility and/or sperm transport (emission). These men have shown
improvement in sperm counts and motility after discontinuation of antidepressant
medications.
We propose a crossover pilot study of normal healthy males to ascertain possible effects of
SSRIs on semen parameters. After initial screening semen analyses, subjects will take the
SSRI paroxetine for five weeks. Serial semen analyses will be obtained while on medication
and one month after discontinuation of medication. Comparisons between semen parameters on
and off medication will be used to evaluate the frequency and significance of semen analysis
changes during SSRI treatment.
n/a
Observational Model: Case-Only, Time Perspective: Prospective
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