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

Part of paid clinical trials in Cresskill, New Jersey.

Sponsor
Bar-Chama, Natan, M.D.
Study ID
NCT06194539
Status
Recruiting
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Conditions

  • Fertility Issues

Eligibility Criteria

Sex
MALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Feb 29, 2024
Status verified
Dec 2023
Primary completion
Feb 28, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
75 participants (estimated)

Primary Outcome Measure

Semen Volume [ Time Frame: Two semen samples will be obtained at the initial 3 month study enrollment and then annually for the duration of the study period of 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Natan Bar-Chama MDCresskillNew Jersey07626
Natan Bar-Chama, MD
[email protected]
201-694-1781

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