Impact of Escitalopram on Sperm DNA Fragmentation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sperm DNA Fragmentation, Infertility, Male

Intervention / Treatment
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* Drug: Escitalopram
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram<br>10mg by mouth daily for 6 weeks | Drug: Escitalopram<br>* 10mg by mouth daily for 6 weeks<br>|
| Placebo Comparator: Placebo<br>Matched placebo control by mouth for 6 weeks. | Other: Placebo<br>* matched placebo control by mouth for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in sperm DNA fragmentation | TUNEL assay for sperm DNA fragmentation | 0 (baseline), 6, 10 weeks | 
| Changes in sperm motility | Percentage of motile sperm in semen analysis | 0 (baseline), 6, 10 weeks | 
| Changes in progressive motility | Percentage of progressive motile sperm in semen analysis | 0 (baseline), 6, 10 weeks | 
| Changes in viability | Percentage of viable sperm in semen analysis | 0 (baseline), 6, 10 weeks | 
| Changes in concentration | Sperm concentration (number of sperm/mL) in semen analysis | 0 (baseline), 6, 10 weeks |