Testicular Evaluation of Azoospermia Using Micro-Ultrasound
1 other identifier
observational
40
2 countries
2
Brief Summary
The investigation is a small feasibility study to determine whether there are imaging features related to the seminiferous tubules in the testes under microultrasound. The results from this study will provide guidance on the design and power analysis of future studies in this area.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2025
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2025
CompletedFirst Posted
Study publicly available on registry
April 24, 2025
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJuly 11, 2025
April 1, 2025
6 months
April 16, 2025
July 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The micro-ultrasound imaging procedure produces imaging features which correlate to the presence of sperm within the seminiferous tubules of the testes
The investigation is a small feasibility study to determine whether there are imaging features related to the seminiferous tubules in the testes under microUS. The results from this study will provide guidance on the design and power analysis of future studies in this area.
From time of enrollment to end of scanning (45 minutes)
Study Arms (3)
Men with azoospermia confirmed based on semen analysis
Post-vasectomy patients with verified azoospermia after the procedure
Men pre-vasectomy with proven natural fertility or with normal semen analysis
Eligibility Criteria
Participants who meet inclusion and exclusion criteria and have been referred to the study infertility clinic.
You may qualify if:
- Men with azoospermia confirmed based on semen analysis
- Post-vasectomy patients with verified azoospermia after the procedure
- Men pre-vasectomy with proven natural fertility or with normal semen analysis
- Males assigned at birth over the age of 18
You may not qualify if:
- History of prior microdissection of the testes
- History of hypogonadotropic hypogonadism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Paul Shinlead
- Exact Imagingcollaborator
Study Sites (2)
Shady Grove Fertility
Rockville, Maryland, 20850, United States
University of Alberta
Edmonton, Alberta, T6G 1Z1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul R Shin, MD
Shady Grove Fertility
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Study Investigator
Study Record Dates
First Submitted
April 16, 2025
First Posted
April 24, 2025
Study Start
May 1, 2025
Primary Completion
October 31, 2025
Study Completion
December 31, 2025
Last Updated
July 11, 2025
Record last verified: 2025-04