Actively Recruiting
The Assessment of Fertility in Men With Spinal Muscular Atrophy (SMA)
Led by Bar-Chama, Natan, M.D. · Updated on 2024-01-08
75
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the fertility status of men diagnosed with Spinal Muscular Atrophy (SMA) who are not currently receiving disease-modifying treatments. The study focuses on understanding fertility through various assessments, including questionnaires about SMA diagnosis, disease burden, medical history, medication usage, and fertility perspectives. It is an observational study lasting 24 months. Participants will complete online questionnaires initially and during follow-up periods. During the first 3 months, they will provide two semen samples for analysis and undergo sperm quality testing using DNA fragmentation through home collection kits sent to a central laboratory. Additionally, participants will have a blood test to measure male reproductive hormone levels during this baseline period. Over the 24-month study duration, yearly semen analyses and questionnaires will continue. Throughout the study, participants will be involved in providing semen samples and completing regular online questionnaires about their health and fertility. Researchers will measure semen volume, sperm concentration, motility, morphology, and DNA fragmentation initially and annually. Hormone levels like testosterone, follicle-stimulating hormone, luteinizing hormone, and estradiol will be assessed at baseline. This comprehensive monitoring aims to gather detailed information about fertility over time in men with SMA.
CONDITIONS
Brief 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 at the 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
- History of radiation therapy
- History of prostate or testicular cancer
- Undescended testicles
- Use of anabolic steroids or testosterone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote or in-person)
Duration - 3 months
Participants complete online questionnaires and provide semen samples and blood tests to assess fertility status and male reproductive hormone levels.
2 home semen sample collections and 1 blood test visit
Duration - 24 months
Participants complete yearly semen analyses and online questionnaires to monitor fertility status over the 24-month study duration.
Yearly home semen sample collections and online questionnaire completions
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
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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