Testicular Evaluation of Azoospermia Using Micro-Ultrasound

NCT ID: NCT06941922

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Azoospermia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Men with azoospermia confirmed based on semen analysis

No interventions assigned to this group

Post-vasectomy patients with verified azoospermia after the procedure

No interventions assigned to this group

Men pre-vasectomy with proven natural fertility or with normal semen analysis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Exact Imaging

INDUSTRY

Sponsor Role collaborator

Paul Shin

OTHER

Sponsor Role lead

Responsible Party

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Paul Shin

Principal Study Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Paul R Shin, MD

Role: PRINCIPAL_INVESTIGATOR

Shady Grove Fertility

Locations

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Shady Grove Fertility

Rockville, Maryland, United States

Site Status RECRUITING

University of Alberta

Edmonton, Alberta, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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Paul R Shin, MD

Role: CONTACT

202-296-2595

Cori Tanrikut, MD

Role: CONTACT

(202)296-2595

Facility Contacts

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Paul R Shin, MD

Role: primary

202-295-2595

Philip V Bach, MD

Role: primary

780-407-5800

Adam Kinnaird, MD, PhD

Role: backup

780-407-5800

Other Identifiers

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SHIN-2024-001

Identifier Type: -

Identifier Source: org_study_id

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