Sperm DNA FragmentationPhase 2NCT03527043
Impact of Escitalopram on Sperm DNA Fragmentation
A Phase 2 study testing Escitalopram in people with Sperm DNA Fragmentation and Infertility, Male, run by Weill Medical College of Cornell University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sperm DNA Fragmentation, Infertility, Male
- What is being tested?
- Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 31 May 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Sperm DNA Fragmentation, Infertility, Male
- Being tested
- Escitalopram, Placebo
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
10mg by mouth daily for 6 weeks
PlaceboOther
matched placebo control by mouth for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Experimental | 10mg by mouth daily for 6 weeks Receives: Drug: Escitalopram |
| Placebo | Placebo comparator | Matched placebo control by mouth for 6 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Have Abnormal (>7%) TUNEL DNA Fragmentation Levels After 6 Weeks of Treatment
TUNEL assay for sperm DNA fragmentation,Percentage of patients who have abnormal (>7%) TUNEL DNA fragmentation levels after 6 weeks of treatment
Measured: 6 weeks
Secondary outcomes (2)
Percentage of Patients Who Have Abnormal DNA Fragmentation Levels at 10 Weeks (4 Weeks Following Cessation of Treatment)
Tunnel assay of the DNA fragmentation, Percentage of patients who have abnormal DNA fragmentation levels at 10 weeks (4 weeks following cessation of treatment)
Measured: 10 weeks
Absolute Change in DNA Fragmentation Percentage
Absolute change in DNA fragmentation percentage across treatment groups from baseline
Measured: 0 (baseline), 6, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start1 Oct 2017
- Primary completion4 Apr 2023
- Study completion31 May 2024
Why it stopped: funding stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sperm DNA FragmentationStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Gal, MD, Principal investigator, Weill Medical College of Cornell UniversityPeter Schlegel, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527043
- Sponsor's protocol ID
- 1608017504
- Status last verified
- Jul 2025
- First submitted
- 19 Jan 2018
- Last updated
- 6 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Escitalopram on Sperm DNA Fragmentation: A Randomized Placebo Controlled
- ClinicalTrials.gov ID
- NCT03527043
- Acronym / sponsor ID
- 1608017504
- Conditions
- Sperm DNA Fragmentation, Infertility, Male
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding stopped
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Posted 25 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Experimental | Drug: Escitalopram10mg by mouth daily for 6 weeks |
| Placebo | Placebo comparator | Other: PlaceboMatched placebo control by mouth for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escitalopram10mg by mouth daily for 6 weeks | Drug | Escitalopram |
| Placebomatched placebo control by mouth for 6 weeks | Other | Placebo |
Primary outcome
Percentage of Patients Who Have Abnormal (>7%) TUNEL DNA Fragmentation Levels After 6 Weeks of Treatment
Time frame: 6 weeks
TUNEL assay for sperm DNA fragmentation,Percentage of patients who have abnormal (>7%) TUNEL DNA fragmentation levels after 6 weeks of treatment
2 secondary outcomes
Percentage of Patients Who Have Abnormal DNA Fragmentation Levels at 10 Weeks (4 Weeks Following Cessation of Treatment)
Time frame: 10 weeks
Absolute Change in DNA Fragmentation Percentage
Time frame: 0 (baseline), 6, 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Gal, MD principal investigator
Weill Medical College of Cornell University
Peter Schlegel, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Escitalopram in people with Sperm DNA Fragmentation and Infertility, Male, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Who Have Abnormal (>7%) TUNEL DNA Fragmentation Levels After 6 Weeks of Treatment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.