TeSE (Testicular Sperm Extraction) in Azoospermic Patients: m-TeSE vs. l-TeSE

November 20, 2024 updated by: Mirko Preto, A.O.U. Città della Salute e della Scienza

Preliminary Results of Microsurgical Testicular Exploration for Sperm Retrieval in Azoospermic Patients: A Randomized Controlled Trial Comparing Operating Microscope vs. Surgical Loupes

The aim of the study is to compare surgical outcomes (intra and post-operative complications) and sperm retrieval rates between conventional microsurgical-assisted testicular sperm extraction (m-TeSE - Group A) and testicular sperm extraction performed with surgical loupes (l-TeSE - Group B) in adult males with non-obstructive azoospermia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: To compare surgical outcomes and sperm retrieval rates (SRR) between conventional microsurgical-assisted testicular sperm extraction (m-TeSE - Group A) and testicular sperm extraction performed with surgical loupes (l-TeSE - Group B) in adult males with non-obstructive azoospermia (NOA). A multicentric prospective randomized trial was conducted from March 2022. Adult males with NOA without genetic alterations who agreed to participate in the study and signed the required informed consent were enrolled. SRR, intra and post-operative complications (according to Clavien-Dindo classification), hormonal profile tchanges were considered as outcomes during the follow up period.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Turin, Italy, 10126
        • Molinette - AOU Città della Salute e della Scienza di Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult males
  • Diagnosis of non obstructive azoospermia who required m-TeSE.

Exclusion Criteria:

  • Absence of signed written informed consent
  • Age < 18 years
  • Obstructive azoospermia
  • Genetic anomalies (e.g., Klinefelter syndrome, Kallmann syndrome, Y chromosome microdeletions, CFTR mutations)
  • Previous testicular biopsies/surgical sperm retrieval
  • Personal history of malignant testicular tumor
  • Unilateral cryptorchidism
  • Varicocele
  • Previous chemotherapy/radiotherapy treatments
  • Monorchidism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Microsurgical-assisted testicular sperm extraction (m-TeSE) - Group A
A longitudinal incision of 3cm was made along the scrotal raphe using a scalpel. Surgical dissection proceeded layer by layer. The testis was separated from the surrounding dartos and luxated outside the scrotal sac. A longitudinal incision was made in the tunica vaginalis to allow complete exposure of the tunica albuginea. Two Vicryl 2-0 traction sutures were placed 0.5 cm cranially and caudally to the testicular equatorial line, which was subsequently incised with a scalpel for 3/4 of the testicular circumference. In M-TESE, through the operating microscope, a direct examination of the testicular parenchyma was performed under magnification (20-25x). Multiple testicular specimens were excised. The same procedure is performed on the contralateral side, where instead of the operating microscope, the surgeon uses surgical loupes for magnification (3.5 - 5x).
Device: Microscope
The microscope provides a direct examination of the testicular parenchyma at 20-25x magnification.
Active Comparator: Testicular sperm extraction performed with surgical loupes (l-TeSE) - Group B
A longitudinal incision of 3cm was made along the scrotal raphe using a scalpel. Surgical dissection proceeded layer by layer. The testis was separated from the surrounding dartos and luxated outside the scrotal sac. A longitudinal incision was made in the tunica vaginalis to allow complete exposure of the tunica albuginea. Two Vicryl 2-0 traction sutures were placed 0.5 cm cranially and caudally to the testicular equatorial line, which was subsequently incised with a scalpel for 3/4 of the testicular circumference. In M-TESE, through the operating microscope, a direct examination of the testicular parenchyma was performed under magnification (20-25x). Multiple testicular specimens were excised. The same procedure is performed on the contralateral side, where instead of the operating microscope, the surgeon uses surgical loupes for magnification (3.5 - 5x).
Device: Surgical loupes
Surgical loupes offer magnification of 3.5-5x.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive sperm retrieval
Time Frame: immediately after the surgery
Number of sperm retrieval
immediately after the surgery
Histology
Time Frame: immediately after the surgery
Normal testicular biopsy or Hypospermatogenesis or Germ cell arrest or Sertoli cell-only syndrome or Seminiferous tubule hyalinization or CIS or Immature testis
immediately after the surgery
Johnsen score
Time Frame: immediately after the surgery
Number according to Johnsen score
immediately after the surgery
Sperm vials stored
Time Frame: immediately after the surgery
Number
immediately after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: immediately after the surgery
Minutes
immediately after the surgery
Complications
Time Frame: through study completion, an average of 1 year
Clavien dindo classification
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A.O.U. Città della Salute e della Scienza

Collaborators

Federica Peretti
Ilaria Ferro
Natalia Plamadeala
Martina Scavone
Luca Boeri
Marco Falcone
Lorenzo Cirigliano
Valentina Parolin
Emanuele Zupo
Paolo Gontero

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

November 3, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Estimated)

November 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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