Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Male Fertility Program (MFP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Nancy Brackett, University of Miami
ClinicalTrials.gov Identifier:
NCT01467869
First received: September 29, 2011
Last updated: December 3, 2014
Last verified: December 2014
  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 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 ] [ Designated as safety issue: No ]
    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 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Nancy Brackett, Research Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01467869     History of Changes
Other Study ID Numbers: 19910013
Study First Received: September 29, 2011
Last Updated: December 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
abnormal semen
assisted conception

ClinicalTrials.gov processed this record on March 03, 2015