Recruiting

Observational Study

Sponsor:

Paul Shin

Code:

NCT06941922

Conditions

Azoospermia

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Azoospermia

Study ID

NCT06941922

Start date

May 1, 2025

Status verified date

Apr, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Oct 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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) ]

Central Contacts and Locations

Central contacts

Paul R Shin, MD

202-296-2595paul.shin@sgfertility.com

Cori Tanrikut, MD

(202)296-2595cori.tanrikut@sgfertility.com

Locations

Shady Grove Fertility

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Paul R Shin, MD

202-295-2595paul.shin@sgfertility.com

Principal Investigator:

Paul R Shin, MD

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 1Z1

Contacts

Philip V Bach, MD

780-407-5800pbach@ualberta.ca

Adam Kinnaird, MD, PhD

780-407-5800ask@ualberta.ca

Principal Investigator:

Philip V Bach, MD

More Information

Sponsor

Paul Shin

Last update posted

Jul 11, 2025

Last verified

Apr, 2025

Keywords

  • azoospermia, infertility, microultrasound, microdissection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Paul Shin on 2025-07-11.