Impact of Escitalopram on Sperm DNA Fragmentation

NCT ID: NCT03527043

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2024-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Escitalopram

10mg by mouth daily for 6 weeks

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

10mg by mouth daily for 6 weeks

Placebo

Matched placebo control by mouth for 6 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

matched placebo control by mouth for 6 weeks

Interventions

Escitalopram

10mg by mouth daily for 6 weeks

Intervention Type: DRUG

Placebo

matched placebo control by mouth for 6 weeks

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Gal, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Peter Schlegel, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1608017504

Identifier Type: -

Identifier Source: org_study_id