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

NCT06194539 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2024-01-08

No results posted yet for this study

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

Sponsors & Collaborators

  • Bar-Chama, Natan, M.D.

    lead OTHER

Principal Investigators

  • Natan Bar-Chama, MD · The Mount Sinai Hospital

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2026-02-28
Completion
2026-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06194539 on ClinicalTrials.gov