Impact of Escitalopram on Sperm DNA Fragmentation

Assessing the Impact of Escitalopram on Sperm DNA Fragmentation: A Randomized Placebo Controlled

Double-blind placebo-controlled randomized trial of daily escitalopram for 6 weeks in healthy men with normal semen analyses and no psychiatric history of depression, bipolar, mania or suicidal ideation. Hormone profiles, semen analysis, sperm DNA fragmentation, and sexual function will be measured at baseline, after 6 weeks of therapy, and 4 weeks after discontinuation of therapy (10 weeks into study).

Study Overview

• Status: Terminated
• Conditions: Infertility, Male; Sperm DNA Fragmentation
• Intervention / Treatment: Drug: Escitalopram; Other: Placebo

Detailed Description

SSRI medications, specifically escitalopram is a very commonly prescribed medication among men of reproductive age. Significant evidence exists that they may be harmful for paternal fertility potential in both animal and human studies. However, high quality data is lacking, particularly among commonly used SSRI's such as escitalopram. As such, it is important to properly evaluate the potential effect of escitalopram in a randomized placebo controlled fashion. Results will be important in guiding urologists, psychiatrists and family practitioners regarding discussion surrounding SSRI use in their patients interested in fertility.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Normal semen analyses, or semen analyses with at least 5 million sperm
• Normal TUNEL value (<7%)
• Willing to engage in at least weekly sexual activity, with a partner or alone for the duration of the 10-week study

Exclusion Criteria:

• Azoospermia or severe oligospermia (<5million sperm per semen analysis)
• Presently attempting to conceive pregnancy
• Sexual dysfunction preventing ability to provide semen analysis throughout study or engage in weekly sexual activity
• Current psychiatric disorder including: bipolar, mania, depression, generalized anxiety, social phobia, panic attacks, obsessive compulsive disorder, and schizophrenia.
• Family history of bipolar disorder, or suicide (including 2nd degree relatives)
• Present use of psychotropic agents (prescription or herbal) or anticonvulsants
• Use of sleeping pills
• Alcohol consumption greater that 2oz/day
• Use of illicit drugs
• Inability to read, follow instructions or complete questionnaires in English.
• Use of hormonal medications in past 3 months (androgens, androgen blockade, anabolic steroids, estrogens, herbal)
• Use of medications to enhance sexual function
• History of chemotherapy or pelvic radiation
• Use of Monoamine Oxidase inhibitors (MAOi's) or tricyclic antidepressants (TCAs) within 14 days
• Liver disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Escitalopram; 10mg by mouth daily for 6 weeks	Drug: Escitalopram; 10mg by mouth daily for 6 weeks
Placebo Comparator: Placebo; Matched placebo control by mouth for 6 weeks.	Other: Placebo; matched placebo control by mouth for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Who Have Abnormal (>7%) TUNEL DNA Fragmentation Levels After 6 Weeks of Treatment	TUNEL assay for sperm DNA fragmentation,Percentage of patients who have abnormal (>7%) TUNEL DNA fragmentation levels after 6 weeks of treatment	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Who Have Abnormal DNA Fragmentation Levels at 10 Weeks (4 Weeks Following Cessation of Treatment)	Tunnel assay of the DNA fragmentation, Percentage of patients who have abnormal DNA fragmentation levels at 10 weeks (4 weeks following cessation of treatment)	10 weeks
Absolute Change in DNA Fragmentation Percentage	Absolute change in DNA fragmentation percentage across treatment groups from baseline	0 (baseline), 6, 10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in International Index of Erectile Function Survey	International Index of Erectile Function (IIEF) Survey. Severe Erectile Dysfunction (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no Erectile Dysfunction (22-25)	0 (Baseline), 6, 10 weeks
Serum Testosterone Measurement	Change in serum testosterone (ng/dL)	0 (baseline), 6, 10 weeks
Change in Serum Luteinizing Hormone (LH) (mIU/mL)	Serum Luteinizing hormone measurement, Change in serum luteinizing hormone (LH) (mIU/mL)	0 (baseline), 6, 10 weeks
Change in Serum Follicle-stimulating Hormone (FSH) (mIU/mL)	Serum follicle-stimulating hormone measurement,Change in serum follicle-stimulating hormone (FSH) (mIU/mL)	0 (baseline), 6, 10 weeks
Change in Serum Prolactin (ng/mL)	serum prolactin measurement,Change in serum prolactin (ng/mL)	0 (baseline), 6, 10 weeks

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Peter Schlegel, MD, Weill Medical College of Cornell University; Principal Investigator: Jonathan Gal, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): April 4, 2023
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Infertility; Infertility, Male; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Neurotransmitter Uptake Inhibitors; Serotonin Agents; Selective Serotonin Reuptake Inhibitors; Escitalopram
• Other Study ID Numbers: 1608017504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes