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NCT06194539 | RECRUITING | Fertility Issues

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

Bar-Chama, Natan, M.D.

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.

Condition or disease

Fertility Issues

Detailed 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 75 participants
Official Title : The Assessment of Fertility in Men With Spinal Muscular Atrophy (SMA)
Actual Study Start Date : 2024-02
Estimated Primary Completion Date : 2026-02
Estimated Study Completion Date : 2026-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 50 Years
Sexes Eligible for Study: MALE
Criteria
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
Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)

Location Details

NCT06194539

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Natan Bar-Chama MD

Cresskill, New Jersey, United States, 07626