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Evaluation of New Semen Collection & Transportation Kit

Evaluation of New Semen Collection & Transportation Kit in Maintaining the Quality of Semen Subjected to Overnight Shipping

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04536545
Enrollment
66
Registered
2020-09-02
Start date
2020-08-31
Completion date
2021-06-18
Last updated
2021-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sperm Parameters in Fertile and Infertile Men

Brief summary

Examine the effect of overnight transport conditions on sperm parameters on semen samples collected and mailed to Cleveland Clinic Andrology center.

Interventions

None listed

Sponsors

Turtle Health, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Healthy volunteers
Yes

Inclusion criteria

* Normal healthy men with normozoospermic semen parameters * Infertile men referred by the infertility specialist (urologist)

Exclusion criteria

* Controls with abnormal semen parameters * Infertile men from other referrals (Gynecologists) * Severe oligozoospermic (\<1 x 106 sperm/mL) infertile men

Design outcomes

Primary

MeasureTime frameDescription
Sperm morphology24 hoursChange in sperm morphology from 0 to 24 hours using Kruger criteria
Sperm motility24 hoursChange in sperm motility from 0 to 24 hours in %
Sperm concentration24 hoursChange in sperm concentration from 0 to 24 hours in millions per mL
Sperm forward motility24 hoursChange in sperm forward motility from 0 to 24 hours in %

Secondary

MeasureTime frameDescription
Sperm concentration36 hoursChange in sperm concentration from 0 to 36 hours in millions per mL
Sperm motility36 hoursChange in sperm motility from 0 to 36 hours in %
Sperm forward motility36 hoursChange in sperm forward motility from 0 to 36 hours in %
Sperm morphology36 hoursChange in sperm morphology from 0 to 36 hours using Kruger criteria

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026