Clinical trial NCT00385762: SSRI Effects on Semen Parameters in Men
Official title: Effect of Selective Serotonin Reuptake Inhibitor Antidepressants on Semen Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Human volunteers
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2006-10-11
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

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.

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

Primary outcomes:
measure: Semen Volume
timeFrame: 2 months post initial visit
measure: Sperm Concentration
timeFrame: 2 months post initial visit
measure: Sperm Motility
timeFrame: 2 months post initial visit
measure: Sperm Morphology
timeFrame: 2 months post initial visit
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Department of Urology, Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Peter N. Schlegel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: