Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03527043
Other study ID # 1608017504
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04142112 - Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation N/A
Recruiting NCT04955782 - Abstinence Period and Semen Quality
Recruiting NCT05506722 - Using of Testes Shocker in Improving the Spermatogenesis and Sperms Activity N/A
Not yet recruiting NCT03988361 - Selection of Non Apoptotic Human Sperm for in Vitro Fertilization by Using Magnetic Activated Cell Sorting (MACS)
Completed NCT03319654 - Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle N/A
Not yet recruiting NCT05597631 - G-IVF and Sperm Parameters N/A
Completed NCT05919186 - Effects of Antioxidant Supplementation of Culture Media on IVF Embryos N/A
Recruiting NCT03588949 - Role of Nutritional Support in Idiopathic Male Infertility N/A
Completed NCT02932865 - Modern Analyses of the Semen in Evaluating Male Fertility and Treatment Options of Male Infertility
Completed NCT02310087 - Oral Astaxanthin and Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures N/A
Completed NCT00385346 - Expressive Writing in Male Infertility N/A
Completed NCT04509583 - The Role of Micro Nutrient Supplement in Improvement of the Sperm DNA Fragmentation N/A
Recruiting NCT04144244 - Comparison of the Effect of Microchip and Density Gradient Methods in Intrauterine Insemination Cycles N/A
Recruiting NCT04452305 - Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting N/A
Completed NCT05461079 - Sperm Phenotype and Differentially Methylated Regions
Recruiting NCT05205733 - Expanding Fertility Care to Poor and Low Resourced Settings Study N/A
Completed NCT03960229 - The Evaluation of the Effect of Microfluidic Sperm Sorting Chip 'Labs-on-a-chip' on IVF Success in Male Factor N/A
Not yet recruiting NCT06050031 - Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility
Not yet recruiting NCT03090438 - IVF Outcomes After Varicocele Repair N/A
Recruiting NCT03968367 - To Study the Effect of Magnetic Activated Sperm Sorting on the Outcome of in Vitro Fertilization-embryo Transplantation N/A