Sperm Parameters in Fertile and Infertile Men Clinical Trial
Official title:
Evaluation of New Semen Collection & Transportation Kit in Maintaining the Quality of Semen Subjected to Overnight Shipping
| NCT number | NCT04536545 |
| Other study ID # | 20-729 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 31, 2020 |
| Est. completion date | June 18, 2021 |
| Verified date | July 2021 |
| Source | Turtle Health, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Examine the effect of overnight transport conditions on sperm parameters on semen samples collected and mailed to Cleveland Clinic Andrology center.
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | June 18, 2021 |
| Est. primary completion date | June 18, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cleveland Clinic | Cleveland | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Turtle Health, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sperm concentration | Change in sperm concentration from 0 to 24 hours in millions per mL | 24 hours | |
| Primary | Sperm motility | Change in sperm motility from 0 to 24 hours in % | 24 hours | |
| Primary | Sperm forward motility | Change in sperm forward motility from 0 to 24 hours in % | 24 hours | |
| Primary | Sperm morphology | Change in sperm morphology from 0 to 24 hours using Kruger criteria | 24 hours | |
| Secondary | Sperm concentration | Change in sperm concentration from 0 to 36 hours in millions per mL | 36 hours | |
| Secondary | Sperm motility | Change in sperm motility from 0 to 36 hours in % | 36 hours | |
| Secondary | Sperm forward motility | Change in sperm forward motility from 0 to 36 hours in % | 36 hours | |
| Secondary | Sperm morphology | Change in sperm morphology from 0 to 36 hours using Kruger criteria | 36 hours |