Actively Recruiting

Age: 18Years - 50Years
MALE
NCT06194539

Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)

Led by Bar-Chama, Natan, M.D. · Updated on 2024-01-08

75

Participants Needed

1

Research Sites

125 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will aim to assess the fertility status of men with Spinal Muscular Atrophy (SMA) not on disease-modifying therapies. Participants will: 1. Complete online questionnaires that will assess SMA diagnosis and disease burden, medical and surgical history, medication usage, and fertility status and perspectives. 2. Over the 3-month initial study baseline period participants will provide two separate ejaculates for semen analysis and a single determination of sperm quality using DNA fragmentation testing using home collection and subsequent shipment to a central laboratory. 3. Over the initial study baseline period of 3 months study participants will obtain a blood test to determine male reproductive hormone levels. During the 24-month study duration, participants will be requested to undergo a yearly semen analysis and complete online relevant questionnaires.

CONDITIONS

Official Title

Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)

Who Can Participate

Age: 18Years - 50Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed Informed Consent Form (or assent)
  • Male aged greater than 18 years and less than 50 years
  • Confirmed diagnosis of Spinal Muscular Atrophy (SMA) at time of consent
  • Not currently on disease-modifying therapy for SMA
  • Clinically well and recovered from any acute illness at screening
Not Eligible

You will not qualify if you...

  • History of chemotherapy or radiation therapy
  • History of prostate or testicular cancer
  • History of undescended testicles
  • Use of anabolic steroids or testosterone

AI-Screening

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Trial Site Locations

Total: 1 location

1

Natan Bar-Chama MD

Cresskill, New Jersey, United States, 07626

Actively Recruiting

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Research Team

N

Natan Bar-Chama, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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