Crick
HomeTrialsGenesDrugs23andMeGraphBlogContact
  • Home
  • Trials
  • Genes
  • Drugs
  • 23andMe
  • Graph
  • Blog
  • Contact
Crick

An open-source clinical intelligence platform. Explore clinical trials, gene networks, and molecular structures using public data sources.

Data Sources

  • ClinicalTrials.gov
  • OpenTargets
  • ClinVar
  • PubChem

Links

  • Contact
  • About
  • Privacy

© 2026 Crick. All rights reserved.

Crick is for educational purposes only. Not medical advice.

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

N/ARecruitingNCT06194539
Bar-Chama, Natan, M.D.75 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

75

Conditions

Fertility Issues

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 Years
Medical Language ↔ Plain English
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

Locations (1)

Natan Bar-Chama MD

Cresskill, New Jersey, United States

RECRUITING

Outcomes

Primary Outcomes

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 months

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 months

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 months

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 months

Sperm DNA Fragmentation Assay

Home collected semen ejaculates will be obtained to measure sperm DNA fragmentation rate ( normal \< 30% DNA fragmented sperm)

Time frame: At intial 3 month study enrollment

Secondary Outcomes

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 enrollment

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 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

Time frame: 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

Time frame: At intial 3 month study enrollment

Male Reproductive Hormones - Estradiol

Serum Estradiol level will be obtained where normal values are \< 39 pg/mL

Time frame: At intial 3 month study enrollment

Central Contacts

Natan Bar-Chama, MD

CONTACT

2016941781support@malefertilitysma.com
Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.