Assessing the Fertility Status of Men with Spinal Muscular Atrophy (SMA)
To see if you are eligible to participate in the study please scan the QR code or click the button below:
The fertility status of men affected with Spinal Muscular Atrophy (SMA) is relatively unknown. Due to currently available disease-modifying therapeutics, as well as promising assisted reproductive technologies, there has been a dramatic improvement in overall disease prognosis and prospects regarding future parenthood.
This study will aim to describe and assess the fertility status of men with Spinal Muscular Atrophy (SMA) who have not been on any disease-modifying therapies. This study will take advantage of new technologies that enable home-collected semen samples to be reliably transported to andrology facilities for sperm analysis and cryopreservation. These consequential developments will enable this study to be conducted primarily in the home environment and is uniquely applicable to men with SMA where mobility and access to fertility care are important considerations.
Inclusion Criteria
Males living with SMA (aged 18-50 years old)
Not on any disease-modifying therapies
Adequately recovered from any acute illness at the time of screening
Home-Collected Semen Analysis
Two semen analyses over the initial 3-month study period
Semen analysis will be conducted using home collection techniques and mailed to a centralized laboratory.
Sperm DNA Fragmentation Analysis
A one-time assessment of sperm quality will be performed using a DNA fragmentation assay utilizing a home-collected semen sample.
Serum Levels Of Reproductive Hormones
A one-time reproductive hormonal panel will be obtained at a local Quest Laboratory.
This hormonal panel will include levels of FSH, LH, Total and Free Testosterone, Estradiol, and Prolactin.
Participants will complete questionnaires that will assess SMA categorization, comorbidities, medication usage, disease status and severity.
To assess changes of fertility status over time, study participants will be eligible to undergo an additional semen analysis every 12 months for the duration of the 2-year study period.
A one-time attempt at sperm cryopreservation will be offered to men interested in fertility preservation for up to a period of 24 months.
For your time, travel expenses, and efforts to participate in this study, you will receive two forms of compensation:
Initial Compensation: You will receive $100 upon determining eligibility, completing the consent form, and finishing all study enrollment questionnaires.
Secondary Compensation: You will receive $150 upon completion of all initial enrollment study tests, which include two semen analyses, laboratory tests, and assessment of sperm quality (including DNA fragmentation).
Please note that these compensations are intended to acknowledge your time and expenses related to participation in the study and not as an inducement to participate.
STUDY DESIGN
| Questionnaires | |||
| Semen Analysis | |||
| Sperm DNA Fragmentation | |||
| Hormonal Profile | |||
| Sperm Cryopreservation (eligible for 1 event) |
To see if you are eligible to participate in the study please scan the QR code or click the button below:
If you have further questions, please email us at support@malefertilitysma.com