RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2024-02
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06194539

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed Informed Consent Form (or assent)
  2. * Male and age greater than 18 years and less than 50 years of age with a confirmed diagnosis of SMA at the time of signing the Informed Consent Form (or assent)
  3. * Currently not on a disease-modifying agent or therapy for SMA
  4. * Adequately recovered from any acute illness at the time of screening, and considered clinically well enough to participate in the study.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Natan Bar-Chama, MD
CONTACT
2016941781
support@malefertilitysma.com

Principal Investigator

Natan Bar-Chama, MD
PRINCIPAL_INVESTIGATOR
The Mount Sinai Hospital

Study Locations (Sites)

Natan Bar-Chama MD
Cresskill, New Jersey, 07626
United States

Collaborators and Investigators

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

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02
Study Completion Date2026-07

Study Record Updates

Study Start Date2024-02
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • Men
  • Spinal Muscular Atrophy

Additional Relevant MeSH Terms

  • Fertility Issues