Clinical trial · Observational
Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)
The Assessment of Fertility in Men With Spinal Muscular Atrophy (SMA)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fertility Issues | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Semen Volume
- timeFrame
- Two semen samples will be obtained at the initial 3 month study enrollment and then annually for the duration of the study period of 24 months
- description
- Home collected semen ejaculates will be obtained to measure semen volume (normal \> 1.5ml)
- measure
- Sperm Concentration
- timeFrame
- Two semen samples will be obtained at the initial 3 month study enrollment and then annually for the duration of the study period of 24 months
- description
- Home collected semen ejaculates will be obtained to measure sperm concentration ( normal \> 15 million sperm/ml)
- measure
- Sperm Motility
- timeFrame
- Two semen samples will be obtained at the initial 3 month study enrollment and then annually for the duration of the study period of 24 months
- description
- Home collected semen ejaculates will be obtained to measure sperm motility ( normal \> 39% motile sperm)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available