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N/A N=35

SSRI Effects on Semen Parameters in Men

Healthy

Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Semen Volume — 2.55 mL

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
paroxetine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Male
Sponsor
Weill Medical College of Cornell University
Primary completion
Sep 2007

Outcome Measures

OutcomeResultp-value
PRIMARY
Semen Volume
2.55
PRIMARY
Sperm Concentration
75
PRIMARY
Sperm Motility
50.21
PRIMARY
Sperm Morphology
20.24

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00385762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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