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Impact of Escitalopram on Sperm DNA Fragmentation

Primary Purpose

Sperm DNA Fragmentation, Infertility, Male

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Placebo
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sperm DNA Fragmentation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Escitalopram

Placebo

Arm Description

10mg by mouth daily for 6 weeks

Matched placebo control by mouth for 6 weeks.

Outcomes

Primary Outcome Measures

Proportion of patients converted from normal to abnormal sperm DNA fragmentation from baseline to 6 weeks
TUNEL assay for sperm DNA fragmentation

Secondary Outcome Measures

Absolute change in sperm DNA fragmentation
TUNEL assay for sperm DNA fragmentation
Changes in sperm motility
Percentage of motile sperm in semen analysis
Changes in progressive motility
Percentage of progressive motile sperm in semen analysis
Changes in viability
Percentage of viable sperm in semen analysis
Changes in concentration
Sperm concentration (number of sperm/mL) in semen analysis

Full Information

First Posted
January 19, 2018
Last Updated
April 17, 2023
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT03527043
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sperm DNA Fragmentation, Infertility, Male

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
10mg by mouth daily for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo control by mouth for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
10mg by mouth daily for 6 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
matched placebo control by mouth for 6 weeks
Primary Outcome Measure Information:
Title
Proportion of patients converted from normal to abnormal sperm DNA fragmentation from baseline to 6 weeks
Description
TUNEL assay for sperm DNA fragmentation
Time Frame
0 (baseline), 6 weeks
Secondary Outcome Measure Information:
Title
Absolute change in sperm DNA fragmentation
Description
TUNEL assay for sperm DNA fragmentation
Time Frame
0 (baseline), 6, 10 weeks
Title
Changes in sperm motility
Description
Percentage of motile sperm in semen analysis
Time Frame
0 (baseline), 6, 10 weeks
Title
Changes in progressive motility
Description
Percentage of progressive motile sperm in semen analysis
Time Frame
0 (baseline), 6, 10 weeks
Title
Changes in viability
Description
Percentage of viable sperm in semen analysis
Time Frame
0 (baseline), 6, 10 weeks
Title
Changes in concentration
Description
Sperm concentration (number of sperm/mL) in semen analysis
Time Frame
0 (baseline), 6, 10 weeks
Other Pre-specified Outcome Measures:
Title
Change in serum testosterone (ng/dL)
Description
Serum testosterone measurement
Time Frame
0 (baseline), 6, 10 weeks
Title
Change in serum luteinizing hormone (LH) (mIU/mL)
Description
Serum Luteinizing hormone measurement
Time Frame
0 (baseline), 6, 10 weeks
Title
Change in serum follicle-stimulating hormone (FSH) (mIU/mL)
Description
Serum follicle-stimulating hormone measurement
Time Frame
0 (baseline), 6, 10 weeks
Title
Change in serum prolactin (ng/mL)
Description
serum prolactin measurement
Time Frame
0 (baseline), 6, 10 weeks
Title
Change in International Index of Erectile Function Survey
Description
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)
Time Frame
0 (Baseline), 6, 10 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grace Tan
Phone
212-746-3208
Email
grt2008@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Marinaro, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Schlegel, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Flynn
Phone
212-746-4739
Email
thf3001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Jessia Marinaro, MD
Phone
2127465470
Email
jam9375@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Jessica Marinaro, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Escitalopram on Sperm DNA Fragmentation

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