Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)
- Conditions
- Fertility Issues
- Registration Number
- NCT06194539
- Lead Sponsor
- Bar-Chama, Natan, M.D.
- 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.
- Detailed Description
Study 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 75
- 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.
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Semen Volume 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 Home collected semen ejaculates will be obtained to measure semen volume (normal \> 1.5ml)
Sperm Concentration 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 Home collected semen ejaculates will be obtained to measure sperm concentration ( normal \> 15 million sperm/ml)
Sperm Motility 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 Home collected semen ejaculates will be obtained to measure sperm motility ( normal \> 39% motile sperm)
Sperm DNA Fragmentation Assay At intial 3 month study enrollment Home collected semen ejaculates will be obtained to measure sperm DNA fragmentation rate ( normal \< 30% DNA fragmented sperm)
Sperm Morphology 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 Home collected semen ejaculates will be obtained to measure sperm morphology (normal \> 4% normal sperm morphology)
- Secondary Outcome Measures
Name Time Method Male Reproductive Hormones - Total Testosterone Level At intial 3 month study enrollment Serum total testosterone level will be obtained where normal values are 250 -1100 ng/dL
Male Reproductive Hormones - Free Testosterone Level At intial 3 month study enrollment Serum free testosterone level will be obtained where normal values are 46.0 - 224.0 pg/mL
Male Reproductive Hormones - Follicle Stimulating Hormone At intial 3 month study enrollment Serum FSH ( Follicle StimulatingHormone) level will be obtained where normal values are 1.6 -8.0 mIU/mL
Male Reproductive Hormones - Luteinizing Hormone At intial 3 month study enrollment Serum LH ( Luteinizing Hormone) level will be obtained where normal values are 1.5- 9.3 mIU/mL
Male Reproductive Hormones - Estradiol At intial 3 month study enrollment Serum Estradiol level will be obtained where normal values are \< 39 pg/mL
Trial Locations
- Locations (1)
Natan Bar-Chama MD
🇺🇸Cresskill, New Jersey, United States