Infertility, Male Clinical Trial
Official title:
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).
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 |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
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 |
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