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

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

Recruiting
18-50 years
Male
Phase N/A

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Overview

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.

Description

Study 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.

Eligibility

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

Study details
    Fertility Issues

NCT06194539

Bar-Chama, Natan, M.D.

26 January 2024

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