Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration

NCT03291522 | Active Not Recruiting DMC

• 1 other identifier: PRO17020423
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to use ultrasound-guided rete testis flushing and aspiration technique to retrieve sperm, non-surgically, from the testes of azoospermic men. If sperm are retrieved by this method, it will provide a direct benefit to the infertile men. This protocol will also establish the safety and feasibility of the ultrasound-guided rete testis injection approach in consenting men before the approach is translated to teenage boys.

Conditions

Azoospermia, Nonobstructive; Infertility, Male

Keywords

Testicular sperm extraction

Outcome Measures

Primary Outcomes (1)

• Presence of sperm

  Percentage of time that sperm is found with ultrasound-guided rete testis aspiration

  5 years

Study Arms (1)

Men with azoospermia

Ultrasound-guided rete testis flushing and aspiration

Procedure: Ultrasound-guided rete testis flushing and aspiration

Interventions

Ultrasound-guided rete testis flushing and aspiration PROCEDURE

Ultrasound-guided rete testis flushing and aspiration is performed first. If no sperm is found, the patient can choose to do a standard of care procedure (but not required).

Men with azoospermia

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males over the age of 18 who are diagnosed with azoospermia.

You may qualify if:

• Be a male over the age of 18
• Be diagnosed with azoospermia
• Have 2 testicles
• Sign an approved consent and authorization permitting the release of personal health information. The patient must acknowledge in writing that consent for sperm collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.

You may not qualify if:

• Diagnosed with psychological, psychiatric, or order conditions which prevent giving fully informed consent
• Diagnosed with underlying medical condition that significantly increases their risk of complications from this procedure

Sponsors & Collaborators

• Infertility and IVF Center, St. Louis, MO: collaborator
• University of Pittsburgh: lead

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Azoospermia, Nonobstructive; Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Kyle Orwig, PhD

  University of Pittsburgh/University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 25, 2017
• Study Start: May 10, 2019
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

US (1)