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出境医 / 临床实验 / Impact of Escitalopram on Sperm DNA Fragmentation

Impact of Escitalopram on Sperm DNA Fragmentation

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).

Condition or disease Intervention/treatment Phase
Sperm DNA Fragmentation Infertility, Male Drug: Escitalopram Other: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessing the Impact of Escitalopram on Sperm DNA Fragmentation: A Randomized Placebo Controlled
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Escitalopram
10mg by mouth daily for 6 weeks
 Drug: Escitalopram
10mg by mouth daily for 6 weeks
Placebo Comparator: Placebo
Matched placebo control by mouth for 6 weeks.
 Other: Placebo
matched placebo control by mouth for 6 weeks
Outcome Measures
Primary Outcome Measures :
  1. Proportion of patients converted from normal to abnormal sperm DNA fragmentation from baseline to 6 weeks [ Time Frame: 0 (baseline), 6 weeks ]
    TUNEL assay for sperm DNA fragmentation


Secondary Outcome Measures :
  1. Absolute change in sperm DNA fragmentation [ Time Frame: 0 (baseline), 6, 10 weeks ]
    TUNEL assay for sperm DNA fragmentation

  2. Changes in sperm motility [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Percentage of motile sperm in semen analysis

  3. Changes in progressive motility [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Percentage of progressive motile sperm in semen analysis

  4. Changes in viability [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Percentage of viable sperm in semen analysis

  5. Changes in concentration [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Sperm concentration (number of sperm/mL) in semen analysis


Other Outcome Measures:
  1. Change in serum testosterone (ng/dL) [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Serum testosterone measurement

  2. Change in serum luteinizing hormone (LH) (mIU/mL) [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Serum Luteinizing hormone measurement

  3. Change in serum follicle-stimulating hormone (FSH) (mIU/mL) [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Serum follicle-stimulating hormone measurement

  4. Change in serum prolactin (ng/mL) [ Time Frame: 0 (baseline), 6, 10 weeks ]
    serum prolactin measurement

  5. Change in International Index of Erectile Function Survey [ Time Frame: 0 (Baseline), 6, 10 weeks ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Contacts
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Contact: Adaobi Onunkwo 646-962-0534 ado2007@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Thomas Flynn    212-746-4739    thf3001@med.cornell.edu   
Contact: Monica Coniglio    2127466676    moc4008@med.cornell.edu   
Principal Investigator: Nahid Punjani, MD         
Sub-Investigator: Marc Goldstein, MD         
Sub-Investigator: James Kashanian, MD         
Sub-Investigator: Peter Schlegel, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Nahid Punjani, MD Weill Medical College of Cornell University
Principal Investigator: Peter Schlegel, MD Weill Medical College of Cornell University
Principal Investigator: Phil Bach, MD Weill Medical College of Cornell University
Tracking Information
First Submitted Date  ICMJE January 19, 2018
First Posted Date  ICMJE May 16, 2018
Last Update Posted Date May 5, 2021
Actual Study Start Date  ICMJE October 1, 2017
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019) 		Proportion of patients converted from normal to abnormal sperm DNA fragmentation from baseline to 6 weeks [ Time Frame: 0 (baseline), 6 weeks ]
TUNEL assay for sperm DNA fragmentation
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018) 		Proportion of patients converted from normal to abnormal sperm DNA fragmentation from baseline to 6 weeks [ Time Frame: 6 weeks ]
TUNEL assay for sperm DNA fragmentation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Absolute change in sperm DNA fragmentation [ Time Frame: 0 (baseline), 6, 10 weeks ]
    TUNEL assay for sperm DNA fragmentation
  • Changes in sperm motility [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Percentage of motile sperm in semen analysis
  • Changes in progressive motility [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Percentage of progressive motile sperm in semen analysis
  • Changes in viability [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Percentage of viable sperm in semen analysis
  • Changes in concentration [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Sperm concentration (number of sperm/mL) in semen analysis
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • Absolute change in sperm DNA fragmentation from baseline to 6 and 10 weeks [ Time Frame: 0, 6, 10 weeks ]
    TUNEL assay for sperm DNA fragmentation
  • Changes in sperm motility from baseline to 6 and 10 weeks [ Time Frame: 0, 6, 10 weeks ]
    Percentage of motile sperm in semen analysis
  • Changes in progressive motility from baseline to 6 and 10 weeks [ Time Frame: 0, 6, 10 weeks ]
    Percentage of progressive motile sperm in semen analysis
  • Changes in viability from baseline to 6 and 10 weeks [ Time Frame: 0, 6, 10 weeks ]
    Percentage of viable sperm in semen analysis
  • Changes in concentration from baseline to 6 and 10 weeks [ Time Frame: 0, 6, 10 weeks ]
    Sperm concentration (number of sperm/mL) in semen analysis
Current Other Pre-specified Outcome Measures
 (submitted: April 22, 2019)
  • Change in serum testosterone (ng/dL) [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Serum testosterone measurement
  • Change in serum luteinizing hormone (LH) (mIU/mL) [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Serum Luteinizing hormone measurement
  • Change in serum follicle-stimulating hormone (FSH) (mIU/mL) [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Serum follicle-stimulating hormone measurement
  • Change in serum prolactin (ng/mL) [ Time Frame: 0 (baseline), 6, 10 weeks ]
    serum prolactin measurement
  • Change in International Index of Erectile Function Survey [ Time Frame: 0 (Baseline), 6, 10 weeks ]
    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)
Original Other Pre-specified Outcome Measures
 (submitted: May 15, 2018)
  • Change in serum testosterone (ng/dL) from baseline to 6 and 10 weeks [ Time Frame: 0, 6, 10 weeks ]
    Serum testosterone measurement
  • Change in serum luteinizing hormone (LH) (mIU/mL) from baseline to 6 and 10 weeks [ Time Frame: 0, 6, 10 weeks ]
    Serum Luteinizing hormone measurement
  • Change in serum follicle-stimulating hormone (FSH) (mIU/mL) from baseline to 6 and 10 weeks [ Time Frame: 0, 6, 10 weeks ]
    Serum follicle-stimulating hormone measurement
  • Change in serum prolactin (ng/mL) from baseline to 6 and 10 weeks [ Time Frame: 0, 6, 10 weeks ]
    serum prolactin measurement
  • Change in International Index of Erectile Function Survey from baseline to 6 and 10 weeks [ Time Frame: 0, 6, 10 weeks ]
    International Index of Erectile Function Survey
 
Descriptive Information
Brief Title  ICMJE Impact of Escitalopram on Sperm DNA Fragmentation
Official Title  ICMJE Assessing the Impact of Escitalopram on Sperm DNA Fragmentation: A Randomized Placebo Controlled
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Sperm DNA Fragmentation
  • Infertility, Male
Intervention  ICMJE
  • Drug: Escitalopram
    10mg by mouth daily for 6 weeks
  • Other: Placebo
    matched placebo control by mouth for 6 weeks
Study Arms  ICMJE
  • Experimental: Escitalopram
    10mg by mouth daily for 6 weeks
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo
    Matched placebo control by mouth for 6 weeks.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2019) 		70
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2018) 		45
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Adaobi Onunkwo 646-962-0534 ado2007@med.cornell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03527043
Other Study ID Numbers  ICMJE 1608017504
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nahid Punjani, MD Weill Medical College of Cornell University
Principal Investigator: Peter Schlegel, MD Weill Medical College of Cornell University
Principal Investigator: Phil Bach, MD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP