Infertility, MalePhase 2NCT03038867
Impact of Duloxetine on Male Fertility
A Phase 2 study testing Duloxetine in people with Infertility, Male and Depression, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The investigators are conducting a placebo-controlled, randomized control trial with duloxetine in healthy, fertile men not previously on any antidepressants. Participants will be randomized to either the duloxetine or placebo groups for 6 weeks. 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
- Infertility, Male, Depression
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2016to 31 Aug 2018
- 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
- Healthy men aged 18-65 years old;
- normal or borderline semen analysis (sperm concentration > 10 million/mL, sperm motility > 30%, sperm morphology > 3%);
- willing to engage in sexual activity (alone or with a partner) at least once per week for the duration of the study;
- capable of providing semen sample.
Who cannot join
- Clinically detected varicocele;
- oligoasthenoteratospermia or azoospermia on semen analysis;
- ongoing attempts to initiate pregnancy;
- current sexual dysfunction (classified as moderate or worse on IIEF);
- history of seizure disorder;
- history of previous chemotherapy or radiation therapy;
Show all 15Show fewer
- current psychiatric history or history of bipolar disorder;
- family history of bipolar disorder, depression, or suicide;
- use of any psychotropic medications or anticonvulsants;
- use of sleeping pills more than once per week;
- use of any hormonal medications on a daily or intermittent basis during the preceding 3 months;
- use of medications which may affect hormone measures and/or sexual function;
- inability to read, follow instructions, or complete questionnaires in English;
- consumption of tobacco or illicit drugs;
- consumption of >2oz of alcohol daily.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are conducting a placebo-controlled, randomized control trial with duloxetine in healthy, fertile men not previously on any antidepressants. Participants will be randomized to either the duloxetine or placebo groups for 6 weeks. The investigators will assess changes in sperm DNA fragmentation at 0, 2, 6, 8, and 10 weeks. Other outcomes measured will include semen parameters (sperm concentration, motility, morphology), hormone levels (testosterone, estrogen, prolactin, LH, FSH), and sexual function (IIEF and MSHQ) surveys.
Read the detailed description
Antidepressant medications are commonly prescribed in the USA not only for depression, but also for anxiety disorders such as generalized anxiety disorder and obsessive-compulsive disorder, premature ejaculation, post-traumatic stress disorder, and neuropathic pain. Despite being widely prescribed in the United States in men of reproductive age, the impact of antidepressants on fertility has not been extensively studied.
After noticing worsened semen parameters in men on anti-depressants, the investigators performed the first prospective study to demonstrate a deleterious impact of selective serotonin reuptake inhibitors (SSRI) on sperm DNA integrity, which has been linked to reproductive outcomes. Further small studies have corroborated the negative impact of SSRIs on male fertility, as assessed by semen parameters and/or sperm DNA integrity.
No studies have examined the impact of a newer, but similar, class of antidepressant - the serotonin-norepinephrine reuptake inhibitor (SNRI). Like SSRIs, SNRIs inhibit the reuptake of serotonin, but also act on norepinephrine. The use of SNRIs has increased recently due to their slightly improved efficacy profile when compared to SSRIs. Duloxetine is an SNRI and is one of the most commonly prescribed anti-depressants in the United States.
The investigators are conducting this trial to determine whether or not the administration of duloxetine will result in a deterioration in sperm DNA fragmentation in healthy, fertile men.
- Conditions
- Infertility, Male, Depression
- Being tested
- Duloxetine, Placebo
- Medical subject headings
- Infertility, Male, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week
PlaceboDrug
Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Experimental | Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Receives: Drug: Duloxetine |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks
Number of participants with TUNEL values > 25% at 6 weeks in each treatment group
Measured: 6 Weeks (primary time point of interest)
Number of Participants With Abnormal Sperm DNA Fragmentation at 0 Weeks
Number of participants with Tunel Values > 25% at 0 Weeks (baseline) in each treatment group
Measured: 0 weeks
Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks
Number of participants with Tunel values > 25% at 2 weeks in each treatment group
Measured: 2 weeks
Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks
Number of participants with Tunel values > 25% at 8 weeks in each treatment group
Measured: 8 weeks
Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks
Number of participants with Tunel values > 25% at 10 weeks in each treatment group
Measured: 10 Weeks
Secondary outcomes (50)
Sperm Concentration at 0 Weeks
Sperm concentration (number of sperm/mL) in semen analysis at 0 weeks
Measured: 0 weeks
Sperm Concentration at 2 Weeks
Sperm concentration (number of sperm/mL) in semen analysis at 2 weeks
Measured: 2 weeks
Sperm Concentration at 6 Weeks
Sperm concentration (number of sperm/mL) in semen analysis at 6 weeks
Measured: 6 weeks
Sperm Concentration at 8 Weeks
Sperm concentration (number of sperm/mL) in semen analysis at 8 weeks
Measured: 8 weeks
Sperm Concentration at 10 Weeks
Sperm concentration (number of sperm/mL) in semen analysis at 10 weeks
Measured: 10 Weeks
Sperm Motility at 0 Weeks
Sperm motility (mean percent) at 0 weeks
Measured: 0 weeks
Sperm Motility at 2 Weeks
Sperm motility (mean percent) at 2 weeks
Measured: 2 weeks
Sperm Motility at 6 Weeks
Sperm motility (mean percent) at 6 weeks
Measured: 6 weeks
Sperm Motility at 8 Weeks
Sperm motility (mean percent) at 8 weeks
Measured: 8 weeks
Sperm Motility at 10 Weeks
Sperm motility (mean percent) at 10 weeks
Measured: 10 Weeks
Sperm Head Defects at 0 Weeks
Sperm head defects (mean number) at 0 weeks
Measured: 0 weeks
Sperm Head Defects at 2 Weeks
Sperm head defects (mean number) at 2 weeks
Measured: 2 weeks
Sperm Head Defects at 6 Weeks
Sperm head defects (mean number) at 6 weeks
Measured: 6 weeks
Sperm Head Defects at 8 Weeks
Sperm head defects (mean number) at 8 weeks
Measured: 8 weeks
Sperm Head Defects at 10 Weeks
Sperm head defects (mean number) at 10 weeks
Measured: 10 Weeks
Sperm Neck Defects at 0 Weeks
Sperm neck defects (mean number) at 0 weeks
Measured: 0 weeks
Sperm Neck Defects at 2 Weeks
Sperm neck defects (mean number) at 2 weeks
Measured: 2 weeks
Sperm Neck Defects at 6 Weeks
Sperm neck defects (mean number) at 6 weeks
Measured: 6 weeks
Sperm Neck Defects at 8 Weeks
Sperm neck defects (mean number) at 8 weeks
Measured: 8 weeks
Sperm Neck Defects at 10 Weeks
Sperm neck defects (mean number) at 10 weeks
Measured: 10 Weeks
Sperm Tail Defects at 0 Weeks
Sperm tail defects (mean number) at 0 weeks
Measured: 0 weeks
Sperm Tail Defects at 2 Weeks
Sperm tail defects (mean number) at 2 weeks
Measured: 2 weeks
Sperm Tail Defects at 6 Weeks
Sperm tail defects (mean number) at 6 weeks
Measured: 6 weeks
Sperm Tail Defects at 8 Weeks
Sperm tail defects (mean number) at 8 weeks
Measured: 8 weeks
Sperm Tail Defects at 10 Weeks
Sperm tail defects (mean number) at 10 weeks
Measured: 10 Weeks
Testosterone Level at 0 Weeks
Testosterone level (ng/dL) at 0 weeks
Measured: 0 weeks
Testosterone Level at 2 Weeks
Testosterone level (ng/dL) at 2 weeks
Measured: 2 weeks
Testosterone Level at 6 Weeks
Testosterone level (ng/dL) at 6 weeks
Measured: 6 weeks
Testosterone Level at 8 Weeks
Testosterone level (ng/dL) at 8 weeks
Measured: 8 weeks
Testosterone Level at 10 Weeks
Testosterone level (ng/dL) at 10 weeks
Measured: 10 Weeks
Estrogen Level at 0 Weeks
Estrogen level (pg/mL) at 0 weeks
Measured: 0 weeks
Estrogen Level at 2 Weeks
Estrogen level (pg/mL) at 2 weeks
Measured: 2 weeks
Estrogen Level at 6 Weeks
Estrogen level (pg/mL) at 6 weeks
Measured: 6 weeks
Estrogen Level at 8 Weeks
Estrogen level (pg/mL) at 8 weeks
Measured: 8 weeks
Estrogen Level at 10 Weeks
Estrogen level (pg/mL) at 10 weeks
Measured: 10 Weeks
Prolactin Level at 0 Weeks
Prolactin level (ng/mL) at 0 weeks
Measured: 0 weeks
Prolactin Level at 2 Weeks
Prolactin level (ng/mL) at 2 weeks
Measured: 2 weeks
Prolactin Level at 6 Weeks
Prolactin level (ng/mL) at 6 weeks
Measured: 6 weeks
Prolactin Level at 8 Weeks
Prolactin level (ng/mL) at 8 weeks
Measured: 8 weeks
Prolactin Level at 10 Weeks
Prolactin level (ng/mL) at 10 weeks
Measured: 10 Weeks
Luteinizing Hormone Level at 0 Weeks
Luteinizing hormone level (mIU/mL) at 0 weeks
Measured: 0 weeks
Luteinizing Hormone Level at 2 Weeks
Luteinizing hormone level (mIU/mL) at 2 weeks
Measured: 2 weeks
Luteinizing Hormone Level at 6 Weeks
Luteinizing hormone level (mIU/mL) at 6 weeks
Measured: 6 weeks
Luteinizing Hormone Level at 8 Weeks
Luteinizing hormone level (mIU/mL) at 8 weeks
Measured: 8 weeks
Luteinizing Hormone Level at 10 Weeks
Luteinizing hormone level (mIU/mL) at 10 weeks
Measured: 10 Weeks
Follicle Stimulating Hormone Level at 0 Weeks
Follicle stimulating hormone level (mIU/mL) at 0 weeks
Measured: 0 weeks
Follicle Stimulating Hormone Level at 2 Weeks
Follicle stimulating hormone level (mIU/mL) at 2 weeks
Measured: 2 weeks
Follicle Stimulating Hormone Level at 6 Weeks
Follicle stimulating hormone level (mIU/mL) at 6 weeks
Measured: 6 weeks
Follicle Stimulating Hormone Level at 8 Weeks
Follicle stimulating hormone level (mIU/mL) at 8 weeks
Measured: 8 weeks
Follicle Stimulating Hormone Level at 10 Weeks
Follicle stimulating hormone level (mIU/mL) at 10 weeks
Measured: 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start12 Dec 2016
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
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 Infertility, MaleStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blinded, placebo-controlled, randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Schlegel, MD, Study chair, Weill Medical College of Cornell UniversityNahid Punjani, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038867
- Sponsor's protocol ID
- 1603017099
- Status last verified
- Feb 2020
- First submitted
- 27 Jan 2017
- Last updated
- 12 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Duloxetine on Male Fertility
- ClinicalTrials.gov ID
- NCT03038867
- Acronym / sponsor ID
- 1603017099
- Conditions
- Infertility, Male, Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Posted 26 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are conducting a placebo-controlled, randomized control trial with duloxetine in healthy, fertile men not previously on any antidepressants. Participants will be randomized to either the duloxetine or placebo groups for 6 weeks. The investigators will assess changes in sperm DNA fragmentation at 0, 2, 6, 8, and 10 weeks. Other outcomes measured will include semen parameters (sperm concentration, motility, morphology), hormone levels (testosterone, estrogen, prolactin, LH, FSH), and sexual function (IIEF and MSHQ) surveys.
Detailed description
Antidepressant medications are commonly prescribed in the USA not only for depression, but also for anxiety disorders such as generalized anxiety disorder and obsessive-compulsive disorder, premature ejaculation, post-traumatic stress disorder, and neuropathic pain. Despite being widely prescribed in the United States in men of reproductive age, the impact of antidepressants on fertility has not been extensively studied.
After noticing worsened semen parameters in men on anti-depressants, the investigators performed the first prospective study to demonstrate a deleterious impact of selective serotonin reuptake inhibitors (SSRI) on sperm DNA integrity, which has been linked to reproductive outcomes. Further small studies have corroborated the negative impact of SSRIs on male fertility, as assessed by semen parameters and/or sperm DNA integrity.
No studies have examined the impact of a newer, but similar, class of antidepressant - the serotonin-norepinephrine reuptake inhibitor (SNRI). Like SSRIs, SNRIs inhibit the reuptake of serotonin, but also act on norepinephrine. The use of SNRIs has increased recently due to their slightly improved efficacy profile when compared to SSRIs. Duloxetine is an SNRI and is one of the most commonly prescribed anti-depressants in the United States.
The investigators are conducting this trial to determine whether or not the administration of duloxetine will result in a deterioration in sperm DNA fragmentation in healthy, fertile men.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Blinded, placebo-controlled, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: DuloxetineDuloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy men aged 18-65 years old;
- normal or borderline semen analysis (sperm concentration > 10 million/mL, sperm motility > 30%, sperm morphology > 3%);
- willing to engage in sexual activity (alone or with a partner) at least once per week for the duration of the study;
- capable of providing semen sample.
Key exclusion criteria (15 listed)
- Clinically detected varicocele;
- oligoasthenoteratospermia or azoospermia on semen analysis;
- ongoing attempts to initiate pregnancy;
- current sexual dysfunction (classified as moderate or worse on IIEF);
- history of seizure disorder;
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 |
|---|---|---|
| DuloxetineDuloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week | Drug | Duloxetine |
| PlaceboPlacebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week | Drug | Placebo |
Primary outcome
Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks
Time frame: 6 Weeks (primary time point of interest)
Number of participants with TUNEL values > 25% at 6 weeks in each treatment group
Number of Participants With Abnormal Sperm DNA Fragmentation at 0 Weeks
Time frame: 0 weeks
Number of participants with Tunel Values > 25% at 0 Weeks (baseline) in each treatment group
Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks
Time frame: 2 weeks
Number of participants with Tunel values > 25% at 2 weeks in each treatment group
Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks
Time frame: 8 weeks
Number of participants with Tunel values > 25% at 8 weeks in each treatment group
Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks
Time frame: 10 Weeks
Number of participants with Tunel values > 25% at 10 weeks in each treatment group
50 secondary outcomes
Sperm Concentration at 0 Weeks
Time frame: 0 weeks
Sperm Concentration at 2 Weeks
Time frame: 2 weeks
Sperm Concentration at 6 Weeks
Time frame: 6 weeks
Sperm Concentration at 8 Weeks
Time frame: 8 weeks
Sperm Concentration at 10 Weeks
Time frame: 10 Weeks
Sperm Motility at 0 Weeks
Time frame: 0 weeks
Sperm Motility at 2 Weeks
Time frame: 2 weeks
Sperm Motility at 6 Weeks
Time frame: 6 weeks
Sperm Motility at 8 Weeks
Time frame: 8 weeks
Sperm Motility at 10 Weeks
Time frame: 10 Weeks
Sperm Head Defects at 0 Weeks
Time frame: 0 weeks
Sperm Head Defects at 2 Weeks
Time frame: 2 weeks
Sperm Head Defects at 6 Weeks
Time frame: 6 weeks
Sperm Head Defects at 8 Weeks
Time frame: 8 weeks
Sperm Head Defects at 10 Weeks
Time frame: 10 Weeks
Sperm Neck Defects at 0 Weeks
Time frame: 0 weeks
Sperm Neck Defects at 2 Weeks
Time frame: 2 weeks
Sperm Neck Defects at 6 Weeks
Time frame: 6 weeks
Sperm Neck Defects at 8 Weeks
Time frame: 8 weeks
Sperm Neck Defects at 10 Weeks
Time frame: 10 Weeks
Sperm Tail Defects at 0 Weeks
Time frame: 0 weeks
Sperm Tail Defects at 2 Weeks
Time frame: 2 weeks
Sperm Tail Defects at 6 Weeks
Time frame: 6 weeks
Sperm Tail Defects at 8 Weeks
Time frame: 8 weeks
Sperm Tail Defects at 10 Weeks
Time frame: 10 Weeks
Testosterone Level at 0 Weeks
Time frame: 0 weeks
Testosterone Level at 2 Weeks
Time frame: 2 weeks
Testosterone Level at 6 Weeks
Time frame: 6 weeks
Testosterone Level at 8 Weeks
Time frame: 8 weeks
Testosterone Level at 10 Weeks
Time frame: 10 Weeks
Estrogen Level at 0 Weeks
Time frame: 0 weeks
Estrogen Level at 2 Weeks
Time frame: 2 weeks
Estrogen Level at 6 Weeks
Time frame: 6 weeks
Estrogen Level at 8 Weeks
Time frame: 8 weeks
Estrogen Level at 10 Weeks
Time frame: 10 Weeks
Prolactin Level at 0 Weeks
Time frame: 0 weeks
Prolactin Level at 2 Weeks
Time frame: 2 weeks
Prolactin Level at 6 Weeks
Time frame: 6 weeks
Prolactin Level at 8 Weeks
Time frame: 8 weeks
Prolactin Level at 10 Weeks
Time frame: 10 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Infertility, Male
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruitingPhase 3
Comparative Study of Post-Varicocelectomy Myo-inositol vs. Antioxidants vs. Surgery Alone in Infertile Men
Myo-inositol, Post Varicocelectomy
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
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.
Peter Schlegel, MD study chair
Weill Medical College of Cornell University
Nahid Punjani, 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 Duloxetine in people with Infertility, Male and Depression, 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 4 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: finished, as of the sponsor's last update on 12 Mar 2020. 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 26 Feb 2020). 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?
Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks (time frame: 6 Weeks (primary time point of interest)). The study lists 5 primary outcomes in all. 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 12 Mar 2020.