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OpenTrials
Completed

NCT Number: NCT04536545

Evaluation of New Semen Collection & Transportation Kit

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

Completed

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Key information

Conditions

Sperm Parameters in Fertile and Infertile Men

Sex eligibility

Male

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sperm concentration

    Time frame: 24 hours

    Change in sperm concentration from 0 to 24 hours in millions per mL

  2. Sperm motility

    Time frame: 24 hours

    Change in sperm motility from 0 to 24 hours in %

  3. Sperm forward motility

    Time frame: 24 hours

    Change in sperm forward motility from 0 to 24 hours in %

  4. Sperm morphology

    Time frame: 24 hours

    Change in sperm morphology from 0 to 24 hours using Kruger criteria

Secondary outcomes

  1. Sperm concentration

    Time frame: 36 hours

    Change in sperm concentration from 0 to 36 hours in millions per mL

  2. Sperm motility

    Time frame: 36 hours

    Change in sperm motility from 0 to 36 hours in %

  3. Sperm forward motility

    Time frame: 36 hours

    Change in sperm forward motility from 0 to 36 hours in %

  4. Sperm morphology

    Time frame: 36 hours

    Change in sperm morphology from 0 to 36 hours using Kruger criteria

Sponsors and collaborators

Lead sponsor

Turtle Health, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 2, 2020
Registry last updated
Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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