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NCT01467869 Clinical Trial

Male Fertility Program

Spinal Cord Injury Clinical Trial

— MFP  

Official title:
The Miami Project Male Fertility Program

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01467869
Other study ID # 19910013
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1991
Est. completion date December 2036

Study information
Verified date September 2023
Source University of Miami
Contact Orrey Padilla
Phone 305-243-1491
Email oxp210@miami.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2036
Est. primary completion date December 2033
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States The Maimi Project to Cure Paralysis Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary spinal cord injury (SCI) subjects will learn the best method to obtain their semen and of their possible options for assisted conception. 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. 2 visits; subjects will provide samples each month up to an average of 2-3 months
See also
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