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

Fertility Issues Clinical Trial

Official title:

The Assessment of Fertility in Men With Spinal Muscular Atrophy (SMA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194539
• Other study ID #: ML44640
• Status: Recruiting
• Start date: February 2024
• Est. completion date: July 2026

Study information

• Verified date: December 2023
• Source: Bar-Chama, Natan, M.D.
• Contact: Natan Bar-Chama, MD
• Phone: 2016941781
• Email: support[@]malefertilitysma.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 2026
• Est. primary completion date: February 2026
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Fertility Issues
• Infertility
• Muscular Atrophy
• Muscular Atrophy, Spinal

Locations

Country	Name	City	State
United States	Natan Bar-Chama MD	Cresskill	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bar-Chama, Natan, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Semen Volume	Home collected semen ejaculates will be obtained to measure semen volume (normal > 1.5ml)	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
Primary	Sperm Concentration	Home collected semen ejaculates will be obtained to measure sperm concentration ( normal > 15 million sperm/ml)	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
Primary	Sperm Motility	Home collected semen ejaculates will be obtained to measure sperm motility ( normal > 39% motile sperm)	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
Primary	Sperm Morphology	Home collected semen ejaculates will be obtained to measure sperm morphology (normal > 4% normal 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
Primary	Sperm DNA Fragmentation Assay	Home collected semen ejaculates will be obtained to measure sperm DNA fragmentation rate ( normal < 30% DNA fragmented sperm)	At intial 3 month study enrollment
Secondary	Male Reproductive Hormones - Total Testosterone Level	Serum total testosterone level will be obtained where normal values are 250 -1100 ng/dL	At intial 3 month study enrollment
Secondary	Male Reproductive Hormones - Free Testosterone Level	Serum free testosterone level will be obtained where normal values are 46.0 - 224.0 pg/mL	At intial 3 month study enrollment
Secondary	Male Reproductive Hormones - Follicle Stimulating Hormone	Serum FSH ( Follicle StimulatingHormone) level will be obtained where normal values are 1.6 -8.0 mIU/mL	At intial 3 month study enrollment
Secondary	Male Reproductive Hormones - Luteinizing Hormone	Serum LH ( Luteinizing Hormone) level will be obtained where normal values are 1.5- 9.3 mIU/mL	At intial 3 month study enrollment
Secondary	Male Reproductive Hormones - Estradiol	Serum Estradiol level will be obtained where normal values are < 39 pg/mL	At intial 3 month study enrollment