UnknownNot Applicable

Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)

United States75 participantsStarted 2024-02

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

Sperm Morphology

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

Sperm DNA Fragmentation Assay

Timeframe: At intial 3 month study enrollment

Trial details

NCT IDNCT06194539

SponsorBar-Chama, Natan, M.D.

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02

Contact for this trial

Natan Bar-Chama, MD

2016941781 support@malefertilitysma.com

View on ClinicalTrials.gov More Fertility Issues trials

Plain-language summary

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

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

Sperm Morphology

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

Sperm DNA Fragmentation Assay

Timeframe: At intial 3 month study enrollment