NCT04536545

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

August 31, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2021

Completed
Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

10 months

First QC Date

August 25, 2020

Last Update Submit

July 1, 2021

Conditions

Sperm Parameters in Fertile and Infertile Men

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Sperm concentration

    36 hours

  • Sperm motility

    36 hours

  • Sperm forward motility

    36 hours

  • Sperm morphology

    36 hours

Eligibility Criteria

Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Fertile and infertile men in the Cleveland area

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

  • Ashok Agarwal, PhD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 2, 2020

Study Start

August 31, 2020

Primary Completion

June 18, 2021

Study Completion

June 18, 2021

Last Updated

July 6, 2021

Record last verified: 2021-07

Locations

US(1)