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
This trial does not accept healthy volunteersQualifiers
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 population
75 men between the ages of 18 -50 with a diagnosis of SMA who are not on disease-modifying therapies.
Trial design
Design model
Ecologic or community
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Semen Volume
Home collected semen ejaculates will be obtained to measure semen volume (normal \> 1.5ml)
Time frame
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 months2
Sperm Concentration
Home collected semen ejaculates will be obtained to measure sperm concentration ( normal \> 15 million sperm/ml)
Time frame
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 months3
Sperm Motility
Home collected semen ejaculates will be obtained to measure sperm motility ( normal \> 39% motile sperm)
Time frame
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 months4
Sperm Morphology
Home collected semen ejaculates will be obtained to measure sperm morphology (normal \> 4% normal sperm morphology)
Time frame
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 monthsSecondary outcomes
1
Male Reproductive Hormones - Total Testosterone Level
Serum total testosterone level will be obtained where normal values are 250 -1100 ng/dL
Time frame
At intial 3 month study enrollment2
Male Reproductive Hormones - Free Testosterone Level
Serum free testosterone level will be obtained where normal values are 46.0 - 224.0 pg/mL
Time frame
At intial 3 month study enrollment3
Male Reproductive Hormones - Follicle Stimulating Hormone
Serum FSH ( Follicle StimulatingHormone) level will be obtained where normal values are 1.6 -8.0 mIU/mL
Time frame
At intial 3 month study enrollment4
Male Reproductive Hormones - Luteinizing Hormone
Serum LH ( Luteinizing Hormone) level will be obtained where normal values are 1.5- 9.3 mIU/mL
Time frame
At intial 3 month study enrollmentSponsors and contacts
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Source ClinicalTrials.gov