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RECRUITING
NCT06194539

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

Sponsor: Bar-Chama, Natan, M.D.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

75

Start Date

2024-02

Completion Date

2026-07

Last Updated

2024-01-08

Healthy Volunteers

Not specified

Locations (1)

Natan Bar-Chama MD

Cresskill, New Jersey, United States