Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06194539 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial
NCT06194539 · ClinicalTrials.gov record · last posted 2024-01-08

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

StatusUnknown
PhaseNot specified
Started2024-02
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 8, 2024 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
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.

Protocol amendment history 1 change detected by DataLookout

2026-08-09
minor
Trial status changed: Recruiting → Unknown
Trial Details
NCT Number NCT06194539
Lead Sponsor Bar-Chama, Natan, M.D.
Conditions Fertility Issues
Enrollment 75 participants
Start Date 2024-02
Primary Completion 2026-02 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2024-01-08