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

Description

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

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Study Overview

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Study Details

Study 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.

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

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

Condition
Fertility Issues
Intervention / Treatment

-

Contacts and Locations

Cresskill

Natan Bar-Chama MD, Cresskill, New Jersey, United States, 07626

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bar-Chama, Natan, M.D.,

Natan Bar-Chama, MD, PRINCIPAL_INVESTIGATOR, The Mount Sinai Hospital

Study Record Dates

2026-07