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Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)
Sponsor: Bar-Chama, Natan, M.D.
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.
Official title: The Assessment of Fertility in Men With Spinal Muscular Atrophy (SMA)
Key Details
Gender
MALE
Age Range
18 Years - 50 Years
Study Type
OBSERVATIONAL
Enrollment
75
Start Date
2024-02
Completion Date
2026-07
Last Updated
2024-01-08
Healthy Volunteers
Not specified
Conditions
Locations (1)
Natan Bar-Chama MD
Cresskill, New Jersey, United States