Testicular Elastography for Microscopic Testicular Sperm Extraction
NCT Number: NCT06524258
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Azoospermia|Elasticity Imaging Techniques|Fertility Preservation
Interventions: DIAGNOSTIC_TEST: testicular elastography
Sponsor: Uşak University
Collaborators: Harran University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2020-01-01
Completion Date: 2021-03-30
Locations: Harran Üniversitesi, Şanlıurfa, Halilye, 63290, Turkey

Summary:
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.

Primary Outcome Measures: shear wave elastography right upper pole of the testes, 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, 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, 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, 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, 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, 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: micro-tese surgery sperm retrieval, 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