Fertility IssuesNCT06194539
Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)
An observational study of Fertility Issues, run by Bar-Chama, Natan, M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Fertility Issues
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2024to Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Adult
Study population: 75 men between the ages of 18 -50 with a diagnosis of SMA who are not on disease-modifying therapies.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Natan Bar-Chama MD
Cresskill, New Jersey, 07626
Natan Bar-Chama, MD, 201-694-1781, support@malefertilitysma.com
About this study
Official title: The Assessment of Fertility in Men With Spinal Muscular Atrophy (SMA)
This study will aim to assess the fertility status of men with Spinal Muscular Atrophy (SMA) not on disease-modifying therapies.
Participants will:
Read more
- Complete online questionnaires that will assess SMA diagnosis and disease burden, medical and surgical history, medication usage, and fertility status and perspectives.
- 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.
- 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.
Read the detailed description
Study participants will:
- Complete online questionnaires that will assess SMA diagnosis and disease burden, medical and surgical history, medication usage, and fertility status and perspectives.
- 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.
- 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
- Fertility Issues
- Keywords
- Men, Spinal Muscular Atrophy
- Medical subject headings
- Infertility, Multiple Endocrine Neoplasia Type 1, Muscular Atrophy, Spinal
What is being measured
The primary outcome is the main question the study is designed to answer.
Semen Volume
Home collected semen ejaculates will be obtained to measure semen volume (normal > 1.5ml)
Measured: 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
Home collected semen ejaculates will be obtained to measure sperm concentration ( normal > 15 million sperm/ml)
Measured: 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
Home collected semen ejaculates will be obtained to measure sperm motility ( normal > 39% motile sperm)
Measured: 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
Home collected semen ejaculates will be obtained to measure sperm morphology (normal > 4% normal sperm morphology)
Measured: 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
Home collected semen ejaculates will be obtained to measure sperm DNA fragmentation rate ( normal < 30% DNA fragmented sperm)
Measured: At intial 3 month study enrollment
Secondary outcomes (5)
Male Reproductive Hormones - Total Testosterone Level
Serum total testosterone level will be obtained where normal values are 250 -1100 ng/dL
Measured: At intial 3 month study enrollment
Male Reproductive Hormones - Free Testosterone Level
Serum free testosterone level will be obtained where normal values are 46.0 - 224.0 pg/mL
Measured: At intial 3 month study enrollment
Male Reproductive Hormones - Follicle Stimulating Hormone
Serum FSH ( Follicle StimulatingHormone) level will be obtained where normal values are 1.6 -8.0 mIU/mL
Measured: At intial 3 month study enrollment
Male Reproductive Hormones - Luteinizing Hormone
Serum LH ( Luteinizing Hormone) level will be obtained where normal values are 1.5- 9.3 mIU/mL
Measured: At intial 3 month study enrollment
Male Reproductive Hormones - Estradiol
Serum Estradiol level will be obtained where normal values are < 39 pg/mL
Measured: At intial 3 month study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bar-Chama, Natan, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natan Bar-Chama, MD, Principal investigator, The Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194539
- Sponsor's protocol ID
- ML44640
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Fertility in Men With Spinal Muscular Atrophy (SMA)
- ClinicalTrials.gov ID
- NCT06194539
- Acronym / sponsor ID
- ML44640
- Conditions
- Fertility Issues
- Keywords
- Men, Spinal Muscular Atrophy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Bar-Chama, Natan, M.D.University, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will aim to assess the fertility status of men with Spinal Muscular Atrophy (SMA) not on disease-modifying therapies.
Participants will:
- Complete online questionnaires that will assess SMA diagnosis and disease burden, medical and surgical history, medication usage, and fertility status and perspectives.
- 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.
- 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:
- Complete online questionnaires that will assess SMA diagnosis and disease burden, medical and surgical history, medication usage, and fertility status and perspectives.
- 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.
- 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- 75 men between the ages of 18 -50 with a diagnosis of SMA who are not on disease-modifying therapies.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Semen Volume
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 months
Home collected semen ejaculates will be obtained to measure semen volume (normal > 1.5ml)
Sperm Concentration
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 months
Home collected semen ejaculates will be obtained to measure sperm concentration ( normal > 15 million sperm/ml)
Sperm Motility
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 months
Home collected semen ejaculates will be obtained to measure sperm motility ( normal > 39% motile sperm)
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 months
Home collected semen ejaculates will be obtained to measure sperm morphology (normal > 4% normal sperm morphology)
Sperm DNA Fragmentation Assay
Time frame: At intial 3 month study enrollment
Home collected semen ejaculates will be obtained to measure sperm DNA fragmentation rate ( normal < 30% DNA fragmented sperm)
5 secondary outcomes
Male Reproductive Hormones - Total Testosterone Level
Time frame: At intial 3 month study enrollment
Male Reproductive Hormones - Free Testosterone Level
Time frame: At intial 3 month study enrollment
Male Reproductive Hormones - Follicle Stimulating Hormone
Time frame: At intial 3 month study enrollment
Male Reproductive Hormones - Luteinizing Hormone
Time frame: At intial 3 month study enrollment
Male Reproductive Hormones - Estradiol
Time frame: At intial 3 month study enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natan Bar-Chama, MD principal investigator
The Mount Sinai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Issues, run by Bar-Chama, Natan, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natan Bar-Chama, MD (2016941781, support@malefertilitysma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semen Volume (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 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.