NCT06194539 Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)
| NCT ID | NCT06194539 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bar-Chama, Natan, M.D. |
| Condition | Fertility Issues |
| Study Type | OBSERVATIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-02 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 75 participants in total. It began in 2024-02 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: 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
Contact & Investigator
Natan Bar-Chama, MD
PRINCIPAL INVESTIGATOR
The Mount Sinai Hospital
Frequently Asked Questions
Who can join the NCT06194539 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 50 Years, studying Fertility Issues. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06194539 currently recruiting?
Yes, NCT06194539 is actively recruiting participants. Contact the research team at support@malefertilitysma.com for enrollment information.
Where is the NCT06194539 trial being conducted?
This trial is being conducted at Cresskill, United States.
Who is sponsoring the NCT06194539 clinical trial?
NCT06194539 is sponsored by Bar-Chama, Natan, M.D.. The principal investigator is Natan Bar-Chama, MD at The Mount Sinai Hospital. The trial plans to enroll 75 participants.