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

NCT ID: NCT03291522

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-10
• Study Completion Date: 2027-09-01

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.

Detailed Description

The aim of this study is to demonstrate that ultrasound-guided rete testis aspiration is a safe and effective method to flush and aspirate rare sperm from the testes of men with azoospermia (no sperm in the ejaculate). Current methods to recover sperm from men with azoospermia range from invasive and time consuming micro testicular sperm extraction (microTESE) to fine needle aspiration (FNA), which is less invasive and less time consuming, but also less effective because it is a blind approach. This approach is less invasive; it involves the percutaneous insertion of a hypodermic needle into the rete testis space. This approach is also not blind because the needle is accurately positioned under ultrasound guidance into the rete testis space that is contiguous with all seminiferous tubules (where sperm are made). The investigators will first perform the experimental ultrasound-guided rete testis flushing and aspiration on both testis. If sperm is found, no standard of care procedure (TESE, microTESE etc) will be performed. If sperm is not found, the participant can choose whether or not to proceed with a standard of care procedure. In cases were participants have previously tried a standard of care procedure, they may not want to do that again if the experimental procedure does not work. For the ultrasound-guided rete testis flushing and aspiration, the investigators will flush and aspirate the tubules with 500ul of physiological saline and Optison ultrasound contrast agent in sterile 0.9% saline (routinely used in clinics). Presence of sperm in the aspirate will be determined. The investigators hypothesize that sperm recovery using the ultrasound-guided rete testis injection/aspiration approach will at least as effective as the standard of care approach employed in the Magee male fertility clinic and it will be less invasive.

Conditions

Azoospermia, Nonobstructive; Infertility, Male

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Men with azoospermia

Ultrasound-guided rete testis flushing and aspiration

Ultrasound-guided rete testis flushing and aspiration

Intervention Type: 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).

Interventions

Ultrasound-guided rete testis flushing and aspiration

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).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Infertility and IVF Center, St. Louis, MO

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Kyle Orwig

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyle Orwig, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh/University of Pittsburgh Medical Center

Locations

Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO17020423

Identifier Type: -

Identifier Source: org_study_id