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Assessing Fertility in Men with Spinal Muscular Atrophy (SMA)

This study is looking at the fertility of men with Spinal Muscular Atrophy (SMA) who are not currently taking medications that change the course of their disease. Researchers want to understand how SMA affects fertility by measuring semen volume, sperm concentration, and sperm movement over 24 months. You might be able to join if you are a man between 18 and 50 years old with a confirmed SMA diagnosis and are not on disease-modifying treatments. The study involves completing online questionnaires, providing semen samples for analysis, and having a blood test to check hormone levels. The goal is to learn more about fertility issues in men with SMA.

Study design
This is an observational study planning to enroll 75 men. It is not testing a new treatment but rather observing fertility status.
What's involved
You will complete online questionnaires, provide two semen samples initially and then annually, and have a blood test. These activities will occur over an initial 3-month period and then annually for 24 months.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 24 months, with yearly semen analyses and questionnaires after the initial 3-month period.

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NCT06194539

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

UNKNOWN
Not specifiedAges 18–50Observational
Bar-Chama, Natan, M.D.
~75 participants
Updated 2024-01-08 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Semen Volume
Measured over Two semen samples will be obtained at the initial 3 month study enrollment and then annually for the duration of the study period of 24 months
+4 more outcomes measured

Conditions

Fertility Issues

Explore related trials

Spinal Muscular Atrophy

Where it's being run

1 sites across 1 states
New Jersey1

Study leadership

  • Natan Bar-Chama, MD · PRINCIPAL_INVESTIGATOR · The Mount Sinai Hospital

Who to contact

Natan Bar-Chama, MD
[email protected]
2016941781
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Semen VolumeTwo semen samples will be obtained at the initial 3 month study enrollment and then annually for the duration of the study period of 24 months

    Home collected semen ejaculates will be obtained to measure semen volume (normal \> 1.5ml)

  • Sperm ConcentrationTwo semen samples will be obtained at the initial 3 month study enrollment and then annually for the duration of the study period of 24 months

    Home collected semen ejaculates will be obtained to measure sperm concentration ( normal \> 15 million sperm/ml)

  • Sperm MotilityTwo semen samples will be obtained at the initial 3 month study enrollment and then annually for the duration of the study period of 24 months

    Home collected semen ejaculates will be obtained to measure sperm motility ( normal \> 39% motile sperm)

  • Sperm MorphologyTwo semen samples will be obtained at the initial 3 month study enrollment and then annually for the duration of the study period of 24 months

    Home collected semen ejaculates will be obtained to measure sperm morphology (normal \> 4% normal sperm morphology)

  • Sperm DNA Fragmentation AssayAt intial 3 month study enrollment

    Home collected semen ejaculates will be obtained to measure sperm DNA fragmentation rate ( normal \< 30% DNA fragmented sperm)