SSRI Effects on Semen Parameters in Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Selective Serotonin Reuptake Inhibitor Antidepressants on Semen Parameters

Conditions
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Healthy

Intervention / Treatment
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* Drug: paroxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal, healthy male volunteers, ages 18-65 Must be able to swallow pills Exclusion Criteria: Known sexual dysfunction Tobacco use Prescription medications History of psychiatric disorders Previous chemotherapy or radiation treatment History of seizure disorder Alcohol use greater than 2 ounces daily Illicit drug use Azoospermia on screening semen analysis Varicocele Currently attempting to achieve pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paroxetine|paroxetine 10-40mg daily x 5 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semen Volume | measured in mL | 2 months post initial visit | 
| Sperm Concentration | number of sperm per cubic centimeter of semen | 2 months post initial visit | 
| Sperm Motility | percent of sperm with movement | 2 months post initial visit | 
| Sperm Morphology | percent of sperm with normal shape | 2 months post initial visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human volunteers