SSRI Effects on Semen Parameters in Men

Completed

• Conditions: Healthy

• Registration Number: NCT00385762
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2006-10-09
• Study First Submitted QC: 2006-10-10
• Study First Posted: 2006-10-11
• Study Start: 2007-01
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Results First Submitted: 2017-02-17
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-19
• Last Update Submitted: 2017-04-19
• Results First Posted: 2017-08-02
• Last Update Posted: 2017-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Semen Volume	2 months post initial visit	measured in mL
Sperm Concentration	2 months post initial visit	number of sperm per cubic centimeter of semen
Sperm Morphology	2 months post initial visit	percent of sperm with normal shape
Sperm Motility	2 months post initial visit	percent of sperm with movement

Trial Locations

Locations (1)

Department of Urology, Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States