ClinicalTrials.gg
Active, not recruitingNCT03291522Updated Nov 6, 2026

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

An observational study in Azoospermia, Nonobstructive and Infertility, Male, sponsored by University of Pittsburgh. Active, not recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by University of Pittsburgh · Observational

Updated Nov 6, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Azoospermia, Nonobstructive
  • Infertility, Male

Keywords

  • Testicular sperm extraction
03

In context

Azoospermia, Nonobstructive

23 studies on the registry are indexed under Azoospermia, Nonobstructive; 7 are open to participants now.

This study's planned enrollment of 50 is below the median of 94 across 10 observational studies indexed under Azoospermia, Nonobstructive.

Browse Azoospermia, Nonobstructive studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Diagnosed with psychological, psychiatric, or order conditions which prevent giving fully
  • Diagnosed with underlying medical condition that significantly increases their risk of complications from this procedure
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Men with azoospermia

    Ultrasound-guided rete testis flushing and aspiration

    Procedure: Ultrasound-guided rete testis flushing and aspiration

Interventions

  • ProcedureUltrasound-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).

06

What researchers measure

Primary outcomes

  1. Presence of sperm

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

    Time frame: 5 years

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started May 2019 (actual). Primary completion is estimated for Jan 2028, 103 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 6, 2026: primary completion Jan 2027 → Jan 2028 and completion Sep 2027 → Sep 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2017
First posted
Sep 25, 2017
StartActual
May 10, 2019
Primary completionEst.
Jan 1, 2028was Jan 2027
CompletionEst.
Sep 1, 2028was Sep 2027
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Jan 1, 2027→Jan 1, 2028
Nov 6, 2026
Study completion
Sep 1, 2027→Sep 1, 2028
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Primary completion Jan 1, 2027→Jan 1, 2028
    Study completion Sep 1, 2027→Sep 1, 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03291522
Collaborators
Infertility and IVF Center, St. Louis, MO
Responsible party
Kyle Orwig (Professor, University of Pittsburgh) — Principal investigator
First posted
Sep 25, 2017
Start date
May 10, 2019
Primary completion
Jan 1, 2028 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

Kyle Orwig, PhD
principal investigator · University of Pittsburgh/University of Pittsburgh Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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