Assessing fertility in men with Spinal Muscular Atrophy
The Assessment of Fertility in Men With Spinal Muscular Atrophy (SMA)
This study is testing the fertility of men with Spinal Muscular Atrophy who aren't on treatment by looking at their medical history, hormone levels, and semen samples over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Sponsor | Bar-Chama, Natan, M.D. Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Cresskill, New Jersey) |
| Trial ID | NCT06194539 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the fertility status of men diagnosed with Spinal Muscular Atrophy (SMA) who are not receiving disease-modifying therapies. Participants will complete online questionnaires regarding their medical history and fertility perspectives, provide semen samples for analysis, and undergo blood tests to assess reproductive hormone levels. The study will span 24 months, during which participants will have yearly semen analyses and complete relevant questionnaires to track changes over time.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 to 50 with a confirmed diagnosis of SMA who are not on any disease-modifying therapies.
Not a fit: Patients with a history of chemotherapy, radiation therapy, prostate or testicular cancer, or those using anabolic steroids or testosterone may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the fertility challenges faced by men with SMA, potentially guiding future interventions.
How similar studies have performed: While studies on fertility in SMA are limited, similar approaches in assessing reproductive health in other conditions have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cresskill, New Jersey
- Natan Bar-Chama MD — Cresskill, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Natan Bar-Chama, MD — The Mount Sinai Hospital
- Study coordinator: Natan Bar-Chama, MD
- Email: support@malefertilitysma.com
- Phone: 2016941781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.