Clinical trial NCT03527043: Impact of Escitalopram on Sperm DNA Fragmentation
Official title: Assessing the Impact of Escitalopram on Sperm DNA Fragmentation: A Randomized Placebo Controlled
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sperm DNA Fragmentation
Infertility, Male
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Patients Who Have Abnormal (>7%) TUNEL DNA Fragmentation Levels After 6 Weeks of Treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: Percentage of Patients Who Have Abnormal DNA Fragmentation Levels at 10 Weeks (4 Weeks Following Cessation of Treatment)
timeFrame: 10 weeks
measure: Absolute Change in DNA Fragmentation Percentage
timeFrame: 0 (baseline), 6, 10 weeks
Other outcomes:
measure: Serum Testosterone Measurement
timeFrame: 0 (baseline), 6, 10 weeks
measure: Change in Serum Luteinizing Hormone (LH) (mIU/mL)
timeFrame: 0 (baseline), 6, 10 weeks
measure: Change in Serum Follicle-stimulating Hormone (FSH) (mIU/mL)
timeFrame: 0 (baseline), 6, 10 weeks
measure: Change in Serum Prolactin (ng/mL)
timeFrame: 0 (baseline), 6, 10 weeks
measure: Change in International Index of Erectile Function Survey
timeFrame: 0 (Baseline), 6, 10 weeks
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jonathan Gal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Peter Schlegel, MD
role: PRINCIPAL_INVESTIGATOR
References: