Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524258
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Testicular Elastography for Microscopic Testicular Sperm Extraction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Testicular Elastography for Predicting the Likelihood of Sperm Retrieval in Microscopic Testicular Sperm Extraction
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Bouins solution and sent for histopathological examination
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 Bouins 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 Bouins solution and sent for histopathological examination
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 Bouins solution and sent for histopathological examination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None