An interventional study of testicular elastography in Azoospermia, Elasticity Imaging Techniques and Fertility Preservation, sponsored by Uşak University. Completed at 1 site in Turkey. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by Uşak University · Not applicable, Interventional, and Diagnostic
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.
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.
59 studies on the registry are indexed under Azoospermia; 17 are open to participants now.
This study's enrollment of 84 is above the median of 57 across 32 interventional studies indexed under Azoospermia.
Browse Azoospermia studies →Uşak University is the lead sponsor of 80 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
micro tese positive
Diagnostic Test: testicular elastography
micro tese negative
Diagnostic Test: testicular elastography
testicular elastography for predicting non obstructive azoospermia
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 day before micro-TESE surgery
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.
Time frame: 1 day after shear wave elastography measurement
Plan to share: No
Ran from Jan 2020 to primary completion in Mar 2021, 14 months.
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