Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)
The Assessment of Fertility in Men With Spinal Muscular Atrophy (SMA)
Bar-Chama, Natan, M.D.
75 participants
Feb 1, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria1
- 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
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06194539