NCT03527043

Impact of Escitalopram on Sperm DNA Fragmentation

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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).

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.

Conditions

• Sperm DNA Fragmentation
• Infertility, Male

Interventions

Type	Name	Description
DRUG	Escitalopram	10mg by mouth daily for 6 weeks
OTHER	Placebo	matched placebo control by mouth for 6 weeks

Timeline

• Start date: 2017-10-01
• Primary completion: 2023-04-04
• Completion: 2024-05-31
• First posted: 2018-05-16
• Last updated: 2025-08-06
• Results posted: 2025-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study