Recruiting

Observational Study

Sponsor:

Bar-Chama, Natan, M.D.

Code:

NCT06194539

Conditions

Fertility Issues

Eligibility Criteria

Sex: Male

Age: 18 - 50

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Fertility Issues

Study ID

NCT06194539

Start date

Feb, 2024

Status verified date

Dec, 2023

Completion date

Jul, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

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 ]
  • 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 ]
  • 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 ]
  • 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 [ Time Frame: At intial 3 month study enrollment ]

Central Contacts and Locations

Central contacts

Natan Bar-Chama, MD

2016941781support@malefertilitysma.com

Locations

Natan Bar-Chama MD

Recruiting

Cresskill, New Jersey, United States, 07626

Contacts

Natan Bar-Chama, MD

201-694-1781support@malefertilitysma.com

More Information

Sponsor

Bar-Chama, Natan, M.D.

Last update posted

Jan 8, 2024

Last verified

Dec, 2023

Keywords

  • Men
  • Spinal Muscular Atrophy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bar-Chama, Natan, M.D. on 2024-01-08.