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Completed

NCT Number: NCT06524258

Testicular Elastography for 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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Harran Üniversitesi

Sanliurfa, Halilye, 63290, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

testicular elastography

Diagnostic Test

testicular elastography for predicting non obstructive azoospermia

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Uşak University

Other

Collaborators

  • Harran University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 29, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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