Impact of Escitalopram on Sperm DNA Fragmentation

Infertility, Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03527043
• Other study ID #: 1608017504
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2017
• Est. completion date: February 2029

Study information

• Verified date: March 2024
• Source: Weill Medical College of Cornell University
• Contact: Grace Tan
• Phone: 212-746-3208
• Email: grt2008[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 2029
• Est. primary completion date: December 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Sperm DNA Fragmentation

Intervention

Drug:
• Escitalopram
10mg by mouth daily for 6 weeks

Other:
• Placebo
matched placebo control by mouth for 6 weeks

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in serum testosterone (ng/dL)	Serum testosterone measurement	0 (baseline), 6, 10 weeks
Other	Change in serum luteinizing hormone (LH) (mIU/mL)	Serum Luteinizing hormone measurement	0 (baseline), 6, 10 weeks
Other	Change in serum follicle-stimulating hormone (FSH) (mIU/mL)	Serum follicle-stimulating hormone measurement	0 (baseline), 6, 10 weeks
Other	Change in serum prolactin (ng/mL)	serum prolactin measurement	0 (baseline), 6, 10 weeks
Other	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
Primary	Proportion of patients converted from normal to abnormal sperm DNA fragmentation from baseline to 6 weeks	TUNEL assay for sperm DNA fragmentation	0 (baseline), 6 weeks
Secondary	Absolute change in sperm DNA fragmentation	TUNEL assay for sperm DNA fragmentation	0 (baseline), 6, 10 weeks
Secondary	Changes in sperm motility	Percentage of motile sperm in semen analysis	0 (baseline), 6, 10 weeks
Secondary	Changes in progressive motility	Percentage of progressive motile sperm in semen analysis	0 (baseline), 6, 10 weeks
Secondary	Changes in viability	Percentage of viable sperm in semen analysis	0 (baseline), 6, 10 weeks
Secondary	Changes in concentration	Sperm concentration (number of sperm/mL) in semen analysis	0 (baseline), 6, 10 weeks