NCT06194539

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Bar-Chama, Natan, M.D. · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: —

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.

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.

Conditions

• Fertility Issues

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-02-01
• Completion: 2026-07-01
• First posted: 2024-01-08
• Last updated: 2024-01-08

Locations

1 site across 1 country: United States