Testicular Evaluation of Azoospermia Using Micro-Ultrasound

July 9, 2025 updated by: Paul Shin
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Currently available ultrasound (US) technology is approximately 12 MHz and offers enough resolution to determine the presence of a tumor or varicocele, but has no real predictive value in terms of imaging robust seminiferous tubules. MicroUS offers significantly higher resolution - down to 70 microns. The average width of a normal seminiferous tubule is 200-250 microns. (Amer 1837). The average width of an atrophic SCO tubule is 75 microns. This echotexture difference cannot be visualized by a conventional ultrasound scan but should, in theory, be detected by a higher resolution (higher MHz) microUS scan.

This is a feasibility study to image 40 azoospermic or healthy controls in order to determine whether microultrasound (microUS) images can visualize differences within the testes of these subjects which may be useful in diagnosing the cause of azoospermia and regional differences within the testes where sperm retrieval may be more effective.

Specifically, in men with obstructive azoospermia we expect to visualize normal seminiferous tubules while in men with non-obstructive azoospermia we expect to visualize both normal and atrophic seminiferous tubules.

The normal tubules in cases of obstructive azoospermia will act as a control by providing an example of normal imaging within a closely related population. Localization of normal tubules within the NOA (non-obstructive azoospermia) population may simplify the microTESE procedure by reducing the amount of dissection required. Additionally, the ability to predict the success of the procedure (i.e. presence of normal tubules) would improve risk/benefit decision-making for men considering it.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z1
        • Recruiting
        • University of Alberta
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Matthew Mancuso, MD
        • Sub-Investigator:
          • Adam Kinnaird, MD, PhD
        • Principal Investigator:
          • Philip V Bach, MD
  • United States
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • Shady Grove Fertility
        • Contact:
        • Principal Investigator:
          • Paul R Shin, MD
        • Sub-Investigator:
          • Cori Tanrikut, MD
        • Sub-Investigator:
          • Russell Hayden, MD
        • Sub-Investigator:
          • Jessica Marinaro, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants who meet inclusion and exclusion criteria and have been referred to the study infertility clinic.

Description

Inclusion criteria:

  1. Men with azoospermia confirmed based on semen analysis
  2. Post-vasectomy patients with verified azoospermia after the procedure
  3. Men pre-vasectomy with proven natural fertility or with normal semen analysis
  4. Males assigned at birth over the age of 18

Exclusion criteria:

  1. History of prior microdissection of the testes
  2. History of hypogonadotropic hypogonadism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The micro-ultrasound imaging procedure produces imaging features which correlate to the presence of sperm within the seminiferous tubules of the testes
Time Frame: From time of enrollment to end of scanning (45 minutes)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul Shin

Collaborators

Exact Imaging

Investigators

  • Principal Investigator: Paul R Shin, MD, Shady Grove Fertility

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 Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 16, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHIN-2024-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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