AzoospermiaNCT06941922
Testicular Evaluation of Azoospermia Using Micro-Ultrasound
An observational study of Azoospermia, run by Paul Shin at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Azoospermia
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants who meet inclusion and exclusion criteria and have been referred to the study infertility clinic.
Who may be able to join
- 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
Who cannot join
- History of prior microdissection of the testes
- History of hypogonadotropic hypogonadism
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Shady Grove Fertility
Rockville, Maryland, 20850
Paul R Shin, MD, 202-295-2595, paul.shin@sgfertility.com
Paul R Shin, MD
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 1Z1
Philip V Bach, MD, 780-407-5800, pbach@ualberta.ca
Adam Kinnaird, MD, PhD, 780-407-5800, ask@ualberta.ca
About this study
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.
Read the 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.
- Conditions
- Azoospermia
- Keywords
- azoospermia, infertility, microultrasound, microdissection
- Medical subject headings
- Azoospermia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Men with azoospermia confirmed based on semen analysis | Not described | |
| Post-vasectomy patients with verified azoospermia after the procedure | Not described | |
| Men pre-vasectomy with proven natural fertility or with normal semen analysis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From time of enrollment to end of scanning (45 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 May 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AzoospermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul Shin
- Sponsor type
- University, hospital or other
- Collaborators
- Exact Imaging
- Responsible party
- Sponsor-investigator, Paul Shin, Shady Grove Fertility Reproductive Science Center
- Investigators
- Paul R Shin, MD, Principal investigator, Shady Grove Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941922
- Sponsor's protocol ID
- SHIN-2024-001
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testicular Evaluation of Azoospermia Using Micro-Ultrasound
- ClinicalTrials.gov ID
- NCT06941922
- Acronym / sponsor ID
- SHIN-2024-001
- Conditions
- Azoospermia
- Keywords
- azoospermia, infertility, microultrasound, microdissection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Paul ShinUniversity, hospital or other
- Collaborators
- Exact Imaging
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who meet inclusion and exclusion criteria and have been referred to the study infertility clinic.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- History of prior microdissection of the testes
- History of hypogonadotropic hypogonadism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Azoospermia
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Active, not recruitingPhase 1/2
A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia
Infertility Due to Azoospermia, Infertility, Male
RecruitingObservational study
Maternal Inheritance of a Pathogenic MT-ND1 Mutation Causes Mitochondrial Dysfunction and Spermatogenic Failure in Men
Azoospermia, Nonobstructive, Cryptozoospermia
RecruitingPhase 1/2
Intra-Testicular Transplantation of Autologous Stem Cells for Treatment of Non-Obstructive Azoospermia Male Infertility.
Non-obstructive Azoospermia
RecruitingPhase 2/3
PKB171 Against Placebo in Couples With Mild Male Factor Infertility
Infertility Due to Azoospermia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul R Shin, MD principal investigator
Shady Grove Fertility
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Azoospermia, run by Paul Shin at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul R Shin, MD (202-296-2595, paul.shin@sgfertility.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.