Sperm Parameters in Fertile and Infertile MenNCT04536545
Evaluation of New Semen Collection & Transportation Kit
An observational study of Sperm Parameters in Fertile and Infertile Men, run by Turtle Health, Inc. at 1 site in United States.
Trial summary
Examine the effect of overnight transport conditions on sperm parameters on semen samples collected and mailed to Cleveland Clinic Andrology center. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sperm Parameters in Fertile and Infertile Men
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2020to 18 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Fertile and infertile men in the Cleveland area
Who may be able to join
- Normal healthy men with normozoospermic semen parameters
- Infertile men referred by the infertility specialist (urologist)
Who cannot join
- Controls with abnormal semen parameters
- Infertile men from other referrals (Gynecologists)
- Severe oligozoospermic (<1 x 106 sperm/mL) infertile men
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of New Semen Collection & Transportation Kit in Maintaining the Quality of Semen Subjected to Overnight Shipping
Examine the effect of overnight transport conditions on sperm parameters on semen samples collected and mailed to Cleveland Clinic Andrology center.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm concentration
Change in sperm concentration from 0 to 24 hours in millions per mL
Measured: 24 hours
Sperm motility
Change in sperm motility from 0 to 24 hours in %
Measured: 24 hours
Sperm forward motility
Change in sperm forward motility from 0 to 24 hours in %
Measured: 24 hours
Sperm morphology
Change in sperm morphology from 0 to 24 hours using Kruger criteria
Measured: 24 hours
Secondary outcomes (4)
Sperm concentration
Change in sperm concentration from 0 to 36 hours in millions per mL
Measured: 36 hours
Sperm motility
Change in sperm motility from 0 to 36 hours in %
Measured: 36 hours
Sperm forward motility
Change in sperm forward motility from 0 to 36 hours in %
Measured: 36 hours
Sperm morphology
Change in sperm morphology from 0 to 36 hours using Kruger criteria
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start31 Aug 2020
- Primary completion18 Jun 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sperm Parameters in Fertile and Infertile MenStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turtle Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashok Agarwal, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536545
- Sponsor's protocol ID
- 20-729
- Status last verified
- Jul 2021
- First submitted
- 25 Aug 2020
- Last updated
- 6 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Semen Collection & Transportation Kit in Maintaining the Quality of Semen Subjected to Overnight Shipping
- ClinicalTrials.gov ID
- NCT04536545
- Acronym / sponsor ID
- 20-729
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Turtle Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Examine the effect of overnight transport conditions on sperm parameters on semen samples collected and mailed to Cleveland Clinic Andrology center.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Fertile and infertile men in the Cleveland area
Key inclusion criteria (2 listed)
- Normal healthy men with normozoospermic semen parameters
- Infertile men referred by the infertility specialist (urologist)
Key exclusion criteria (3 listed)
- Controls with abnormal semen parameters
- Infertile men from other referrals (Gynecologists)
- Severe oligozoospermic (<1 x 106 sperm/mL) infertile men
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sperm concentration
Time frame: 24 hours
Change in sperm concentration from 0 to 24 hours in millions per mL
Sperm motility
Time frame: 24 hours
Change in sperm motility from 0 to 24 hours in %
Sperm forward motility
Time frame: 24 hours
Change in sperm forward motility from 0 to 24 hours in %
Sperm morphology
Time frame: 24 hours
Change in sperm morphology from 0 to 24 hours using Kruger criteria
4 secondary outcomes
Sperm concentration
Time frame: 36 hours
Sperm motility
Time frame: 36 hours
Sperm forward motility
Time frame: 36 hours
Sperm morphology
Time frame: 36 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
Related trials for Sperm Parameters in Fertile and Infertile Men
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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.
Ashok Agarwal, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sperm Parameters in Fertile and Infertile Men, run by Turtle Health, Inc. 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 2 inclusion and 3 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 6 Jul 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sperm concentration (time frame: 24 hours). The study lists 4 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 6 Jul 2021.