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
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

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

External Links

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