CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
testicular elastographyother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06524258
NCT06524258N/ACompleted

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

Uşak University·interventional·Posted Jul 29, 2024·Updated Jul 29, 2024

In Brief

A clinical study evaluating testicular elastography for Azoospermia and 2 related conditions. Completed, enrolled 84 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
CollaboratorsHarran University

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 29, 2024
Enrollment StartJan 1, 2020
Primary CompletionMar 1, 2021
Study CompletionMar 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 1.9 years ago

Interventions

testicular elastographyother

testicular elastography for predicting non obstructive azoospermia