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Male Fertility Program (MFP)

This study is currently recruiting participants.
Verified November 2017 by Nancy Brackett, University of Miami
Sponsor:
ClinicalTrials.gov Identifier:
NCT01467869
First Posted: November 9, 2011
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Nancy Brackett, University of Miami
  Purpose
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
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Miami Project Male Fertility Program

Resource links provided by NLM:


Further study details as provided by Nancy Brackett, University of Miami:

Primary Outcome Measures:
  • spinal cord injury (SCI) subjects will learn the best method to obtain their semen and of their possible options for assisted conception. [ Time Frame: 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.


Estimated Enrollment: 100
Study Start Date: January 1991
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Spinal cord injured men
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467869


Contacts
Contact: Teodoro Aballa 305-243-1491
Contact: Emad Ibrahim 305-243-9082

Locations
United States, Florida
The Maimi Project to Cure Paralysis Recruiting
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
  More Information

Additional Information:
Responsible Party: Nancy Brackett, Research Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01467869     History of Changes
Other Study ID Numbers: 19910013
First Submitted: September 29, 2011
First Posted: November 9, 2011
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by Nancy Brackett, University of Miami:
abnormal semen
assisted conception

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries