Testicular Elastography for Microscopic Testicular Sperm Extraction

July 23, 2024 updated by: Uşak University

Testicular Elastography for Predicting the Likelihood of Sperm Retrieval in Microscopic Testicular Sperm Extraction

Before commencing our study, we obtained approval from the local ethics committee. The study focused on patients who visited our urology outpatient clinic for infertility between January 2020 and March 2021. Eighty-four patients diagnosed with non-obstructive azoospermia were prospectively enrolled in the study.

Azoospermia was diagnosed after performing semen analysis at least twice, adhering to the criteria outlined by the WHO. All patients underwent karyotype analysis and Y microdeletion analysis. Testicular volumes were measured using Prader orchidometry and confirmed by scrotal ultrasonography.

For patients scheduled for Micro-TESE, elastography measurements were conducted in the supine position. These measurements were performed by the same radiologist in the Radiology department. A total of six points Shear Wave Elastography (SWE) measurements were recorded from each patient, including upper right, middle right, lower right, upper left, middle left, and lower left.

All patients underwent the micro-TESE procedure by the same surgeon. The procedure was first applied to the testis with a better volume and consistency. Samples of large and bright tubules were extracted using microforceps under a microscope, utilizing a magnification range of 20X-25X. The tissues obtained were subsequently assessed by the same embryologist who was present in the operating room. The embryologist provides biopsy results indicating the presence or absence of spermatozoa. If five or more mature spermatozoa are observed within the testicular tissues, the procedure is terminated. However, if fewer than five spermatozoa are identified in the tissues, the procedure is repeated on the contralateral testicle to ensure a comprehensive examination and thorough exploration. Tissues containing a satisfactory quantity of sperm were processed and preserved in the incubator until the Intracytoplasmic Sperm Injection (ICSI) procedure which was planned following the sperm cryopreservation of the patients whose sperms could be retrieved. In cases where sperm could not be retrieved from patients, testicular tissue was placed in Bouin's solution and sent for histopathological examination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Before commencing our study, we obtained approval from the local ethics committee. The study focused on patients who visited our urology outpatient clinic for infertility between January 2020 and March 2021. Eighty-four patients diagnosed with non-obstructive azoospermia were prospectively enrolled in the study. Patients with obstructive azoospermia, hypogonadotropic hypogonadism, history of previous testicular disease, previous TESE, and history of chemotherapy or radiotherapy were excluded from the study.

Azoospermia was diagnosed after performing semen analysis at least twice, adhering to the criteria outlined by the WHO. All patients underwent karyotype analysis and Y microdeletion analysis. Testicular volumes were measured using Prader orchidometry and confirmed by scrotal ultrasonography.

For patients scheduled for Micro-TESE, elastography measurements were conducted in the supine position. These measurements were performed by the same radiologist in the Radiology department. A total of six points Shear Wave Elastography (SWE) measurements were recorded from each patient, including upper right, middle right, lower right, upper left, middle left, and lower left.

All patients underwent the micro-TESE procedure by the same surgeon. The procedure was first applied to the testis with a better volume and consistency. Samples of large and bright tubules were extracted using microforceps under a microscope, utilizing a magnification range of 20X-25X. The embryologist provides biopsy results indicating the presence or absence of spermatozoa. If five or more mature spermatozoa are observed within the testicular tissues, the procedure is terminated. However, if fewer than five spermatozoa are identified in the tissues, the procedure is repeated on the contralateral testicle to ensure a comprehensive examination and thorough exploration. Tissues containing a satisfactory quantity of sperm were processed and preserved in the incubator until the Intracytoplasmic Sperm Injection (ICSI) procedure which was planned following the sperm cryopreservation of the patients whose sperms could be retrieved. In cases where sperm could not be retrieved from patients, testicular tissue was placed in Bouin's solution and sent for histopathological examination.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Halilye
      • Şanlıurfa, Halilye, Turkey, 63290
        • Harran Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • non obstructive azoospermia
  • testicular elastography performed
  • micro tese performed

Exclusion Criteria:

  • obstructive azoospermia
  • testicular elastography not performed
  • micro tese not performed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: tese positive
micro tese positive
Diagnostic test: testicular elastography
testicular elastography for predicting non obstructive azoospermia
Other: tese negative
micro tese negative
Diagnostic test: testicular elastography
testicular elastography for predicting non obstructive azoospermia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shear wave elastography right upper pole of the testes
Time Frame: 1 day before micro-TESE surgery
Elastography measurements of the right upper pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.
1 day before micro-TESE surgery
shear wave elastography right middle pole of the testes
Time Frame: 1 day before micro-TESE surgery
Elastography measurements of the right middle pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.
1 day before micro-TESE surgery
shear wave elastography right lower pole of the testes
Time Frame: 1 day before micro-TESE surgery
Elastography measurements of the right lower pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.
1 day before micro-TESE surgery
shear wave elastography left upper pole of the testes
Time Frame: 1 day before micro-TESE surgery
Elastography measurements of the left upper pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.
1 day before micro-TESE surgery
shear wave elastography left middle pole of the testes
Time Frame: 1 day before micro-TESE surgery
Elastography measurements of the left middle pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.
1 day before micro-TESE surgery
shear wave elastography left lower pole of the testes
Time Frame: 1 day before micro-TESE surgery
Elastography measurements of the left lower pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.
1 day before micro-TESE surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
micro-tese surgery sperm retrieval
Time Frame: 1 day after shear wave elastography measurement
All patients underwent the micro-TESE procedure by the same surgeon.Patients were evaluated as positive or negative based on sperm retrieval results.
1 day after shear wave elastography measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uşak University

Collaborators

Harran University

Investigators

  • Study Chair: ADEM TUNÇEKİN, Harran University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRÜ-TUNÇEKİN-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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