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Testicular Elastography for Microscopic Testicular Sperm Extraction

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06524258
Enrollment
84
Registered
2024-07-29
Start date
2020-01-01
Completion date
2021-03-30
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Azoospermia, Elasticity Imaging Techniques, Fertility Preservation

Keywords

share wave elastography, microscopic testicular sperm extraction, azoospermia

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTtesticular elastography

testicular elastography for predicting non obstructive azoospermia

Sponsors

Harran University
CollaboratorOTHER
Uşak University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
shear wave elastography right lower pole of the testes1 day before micro-TESE surgeryElastography measurements of the right lower pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.
shear wave elastography right upper pole of the testes1 day before micro-TESE surgeryElastography measurements of the right upper pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.
shear wave elastography right middle pole of the testes1 day before micro-TESE surgeryElastography measurements of the right middle pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.
shear wave elastography left lower pole of the testes1 day before micro-TESE surgeryElastography measurements of the left lower pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.
shear wave elastography left upper pole of the testes1 day before micro-TESE surgeryElastography measurements of the left upper pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.
shear wave elastography left middle pole of the testes1 day before micro-TESE surgeryElastography measurements of the left middle pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.

Secondary

MeasureTime frameDescription
micro-tese surgery sperm retrieval1 day after shear wave elastography measurementAll patients underwent the micro-TESE procedure by the same surgeon.Patients were evaluated as positive or negative based on sperm retrieval results.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026