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MFP: Male Fertility Program

Sponsor
University of Miami (Other)
Overall Status
Recruiting
CT.gov ID
NCT01467869
Collaborator
(none)
100
Enrollment
1
Location
479
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Following spinal cord injury, most men are infertile and require medical assistance to father children. The conditions that contribute to their infertility are erectile dysfunction, ejaculatory dysfunction, and semen abnormalities. The Miami Project Male Fertility Program is a research study designed to understand and improve impairments to male fertility resulting from spinal cord injury.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Miami Project Male Fertility Program
    Study Start Date :
    Jan 1, 1991
    Anticipated Primary Completion Date :
    Dec 1, 2025
    Anticipated Study Completion Date :
    Dec 1, 2030

    Outcome Measures

    Primary Outcome Measures

    1. spinal cord injury (SCI) subjects will learn the best method to obtain their semen and of their possible options for assisted conception. [2 visits; subjects will provide samples each month up to an average of 2-3 months]

      Studies in the male fertility program will investigate the fertility potential of spinal cord injured men by retrieving semen which will be analyzed for sperm count, motility, morphology, etc., and correlated with patient variables such as age, time of injury, level of injury, bladder management, history of UTI's, hormonal status, etc. the outcome of the research will improve fertility in men with spinal cord injury.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Any man with spinal cord injury over the age of 18. Control Subjects will be any healthy man over the age of 18 with no recent history of infertility
    Exclusion Criteria:
    • Women will be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Maimi Project to Cure Paralysis Miami Florida United States 33136

    Sponsors and Collaborators

    • University of Miami

    Investigators

    • Principal Investigator: Emad Ibrahim, MD, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Emad Ibrahim, Instructor, University of Miami
    ClinicalTrials.gov Identifier:
    NCT01467869
    Other Study ID Numbers:
    • 19910013
    First Posted:
    Nov 9, 2011
    Last Update Posted:
    Nov 17, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Emad Ibrahim, Instructor, University of Miami
    abnormal semen
    assisted conception
    Additional relevant MeSH terms:
    Spinal Cord Injuries

    Study Results

    No Results Posted as of Nov 17, 2021