Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)
ConditionFertility Issues
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-50
SponsorBar-Chama, Natan, M.D.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov