Actively Recruiting
Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)
Led by Bar-Chama, Natan, M.D. · Updated on 2024-01-08
75
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed Informed Consent Form (or assent)
- Male aged greater than 18 years and less than 50 years
- Confirmed diagnosis of Spinal Muscular Atrophy (SMA) at time of consent
- Not currently on disease-modifying therapy for SMA
- Clinically well and recovered from any acute illness at screening
You will not qualify if you...
- History of chemotherapy or radiation therapy
- History of prostate or testicular cancer
- History of undescended testicles
- Use of anabolic steroids or testosterone
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Natan Bar-Chama MD
Cresskill, New Jersey, United States, 07626
Actively Recruiting
Research Team
N
Natan Bar-Chama, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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