Evaluation of New Semen Collection & Transportation Kit

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.

Study Overview

• Status: Completed
• Conditions: Sperm Parameters in Fertile and Infertile Men

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Fertile and infertile men in the Cleveland area

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm concentration	Change in sperm concentration from 0 to 24 hours in millions per mL	24 hours
Sperm motility	Change in sperm motility from 0 to 24 hours in %	24 hours
Sperm forward motility	Change in sperm forward motility from 0 to 24 hours in %	24 hours
Sperm morphology	Change in sperm morphology from 0 to 24 hours using Kruger criteria	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm concentration	Change in sperm concentration from 0 to 36 hours in millions per mL	36 hours
Sperm motility	Change in sperm motility from 0 to 36 hours in %	36 hours
Sperm forward motility	Change in sperm forward motility from 0 to 36 hours in %	36 hours
Sperm morphology	Change in sperm morphology from 0 to 36 hours using Kruger criteria	36 hours

Collaborators and Investigators

• Sponsor: Turtle Health, Inc.
• Investigators: Principal Investigator: Ashok Agarwal, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Actual): June 18, 2021
• Study Completion (Actual): June 18, 2021

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 20-729

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No