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临床试验/NCT06524258
NCT06524258已完成不适用

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

Uşak University2 个研究点 分布在 2 个国家目标入组 84 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
2
主要终点
shear wave elastography right lower pole of the testes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

shear wave elastography right lower pole of the testes

时间窗: 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.

shear wave elastography right upper pole of the testes

时间窗: 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.

shear wave elastography right middle pole of the testes

时间窗: 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.

shear wave elastography left upper pole of the testes

时间窗: 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.

shear wave elastography left middle pole of the testes

时间窗: 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.

shear wave elastography left lower pole of the testes

时间窗: 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.

次要结局

  • micro-tese surgery sperm retrieval(1 day after shear wave elastography measurement)

研究者

发起方
Uşak University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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