Male Fertility Program for Spinal Cord Injury

(MFP Trial)

Overseen By Orrey Padilla

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Women

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2-3 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist men with spinal cord injuries who face fertility challenges, including difficulties with erections, ejaculation, and sperm quality. Researchers seek to understand and improve these fertility issues to enable these men to have children with medical assistance. Men with a spinal cord injury experiencing these fertility problems may be suitable candidates for the study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in fertility solutions.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

The Miami Project Male Fertility Program researches ways to understand and improve male fertility issues after spinal cord injury. While specific safety details are not available, a major grant from the Department of Defense supports the research, indicating its importance and thorough review.

As the trial is in an advanced stage, earlier studies have likely demonstrated its safety for participants. Major safety concerns would have prevented the trial from progressing to this point. This suggests the treatment is generally well-tolerated, but participants should always consult their doctors about any potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Miami Project Male Fertility Program because it aims to address male infertility with a novel approach. Unlike current treatments that often focus on hormonal therapy or surgical procedures, this program explores innovative techniques to enhance fertility potential. The program may incorporate advanced reproductive technologies or regenerative medicine, offering hope for improved success rates and fewer side effects compared to traditional methods. This fresh perspective on male fertility could provide new solutions for individuals struggling with infertility.

What evidence suggests that the Miami Project Male Fertility Program is effective for improving male fertility after spinal cord injury?

Research has shown that many men with spinal cord injuries face fertility challenges, including erectile dysfunction, ejaculation difficulties, and semen issues. Studies from The Miami Project suggest that understanding these problems can lead to better fertility treatments. Early research has focused on identifying the causes of these fertility issues. The goal is to improve reproductive function, potentially helping men with spinal cord injuries become fathers. With ongoing support and research, significant improvements in male fertility outcomes are hopeful. ^{1 2 3 5 6}

Who Is on the Research Team?

Emad Ibrahim, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will learn the best method to obtain their semen and explore options for assisted conception. Semen will be retrieved and analyzed for fertility potential.

2-3 months

2 visits per month

Follow-up

Participants are monitored for improvements in fertility and any changes in semen analysis results after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Miami Project Male Fertility Program

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01467869

Study Details | NCT01467869 | Male Fertility Program

The Miami Project Male Fertility Program is a research study designed to understand and improve impairments to male fertility resulting from spinal cord injury.

2.

themiamiproject.org

themiamiproject.org/research/areas-of-research/fertility/

Fertility Research at The Miami Project to Cure Paralysis

Researchers at The Miami Project are studying the potential causes of fertility issues among men who have sustained a spinal cord injury.

3.

news.med.miami.edu

news.med.miami.edu/dod-grant-study-male-infertility-post-spinal-injury/

Department of Defense Grants Miller School Researcher ...

Miller School researcher receives a $3.25M Department of Defense grant to investigate male infertility following spinal cord injury.

4.

trialx.com

trialx.com/clinical-trials/listings/267869/male-fertility-program/

Male Fertility Program | Clinical Research Trial Listing ...

The Miami Project Male Fertility Program is a research study designed to understand and improve impairments to male fertility resulting from ...

5.

themiamiproject.org

themiamiproject.org/clinical-study-spotlight-male-fertility/

Clinical Study Spotlight: Male Fertility

The results are expected to lead to improved reproductive function in men with SCI and, therefore, a higher quality of life.

6.

themiamiproject.org

themiamiproject.org/wp-content/uploads/male-fertility-booklet-2010-lowres.pdf

Male Fertility Following Spinal Cord Injury

The Male Fertility Research Program of the Miami Project to Cure Paralysis is known around the world for research and clinical efforts in the field of male ...