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

Study Identifier:
ML44640
ClinicalTrials.gov Identifier:
NCT06194539
EudraCT Identifier:
N/A
EU CT Number:
N/A
Sponsor:
Bar-Chama, Natan, M.D.
Recruiting

Study Details

Medical Condition
  • All Spinal Muscular Atrophies
Study Drug
    Date
    Feb 2024 - Feb 2026
    Patient Requirements
    Sex: Male
    Age: 18 - 50 Years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • Inclusion Criteria:
    • Signed Informed Consent Form (or assent)
    • Male and age greater than 18 years and less than 50 years of age with a confirmed diagnosis of SMA at the time of signing the Informed Consent Form (or assent)
    • Currently not on a disease-modifying agent or therapy for SMA
    • Adequately recovered from any acute illness at the time of screening, and considered clinically well enough to participate in the study.
    • Exclusion Criteria:
    • Men with a prior history of chemotherapy, radiation therapy, prostate or testicular cancer, undescended testicles and use of anabolic steroids or testosterone usage will be excluded

    Protocol Summary

    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.

    Trial Locations

    Location
    Status
    Location
    Natan Bar-Chama MD
    Cresskill, New Jersey, United States, 07626
    Status
    Recruiting

    Contact Cure SMA

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