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SSRI Impact On Sperm Quality: A Randomized Placebo Controlled Trial

Clinical Trial Details

This study will test the effect of the oral medication, escitalopram, on male fertility in comparison to a placebo (pills with no study drug). Escitalopram is approved by the U.S. Food and Drug Administration (FDA) and is a commonly prescribed anti-depressant among men of reproductive age. Escitalopram is thought to have negative effects on male fertility but has never been assessed in comparison to a placebo or for healthy individuals.

Participants will be randomized into one of the study groups to receive either a placebo or escitalopram for 6 weeks. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

Prior to taking the first pill, all participants will receive semen and blood testing, as well as take two questionnaires. Upon completion of taking the pills, participants will come back to the office twice more for the same tests and questionnaires. 

All participants must engage in sexual activity (either with a partner or via self-stimulation) at least once per week during the study. Total study participation is expected to last 10 weeks.

Key Eligibility: 
  1. Open to healthy men 18-65 years of age with normal semen analyses that are willing to engage in at least weekly sexual activity, with a partner or alone for the duration of the 10- week study
  2. Participants must not have any psychiatric history of depression, bipolar, mania, or suicidal ideation.

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Thomas Flynn
thf3001@med.cornell.edu

Grace Tan
212-746-3208
grt2008@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1608017504

ClinicalTrials.gov:

NCT03527043

Sponsor:

1608017504

Status

Open to Enrollment

Age Group

Adult

Sponsor