Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)
Status unconfirmed
Conditions studied: Fertility Issues
In brief
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.
Key facts
- Study ID
- NCT06194539
- Run by
- Bar-Chama, Natan, M.D.
- People needed
- 75
- Starts
- 2024-02-01
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2024-01-08
Who can join
Age: 18 and older, up to 50. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Natan Bar-Chama MD — Cresskill, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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