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Completed

NCT Number: NCT06702397

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

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.

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Key information

Conditions

Azoospermia, Nonobstructive

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Molinette - AOU Città della Salute e della Scienza di Torino

Turin, 10126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microscope

Device

The microscope provides a direct examination of the testicular parenchyma at 20-25x magnification.

Surgical loupes

Device

Surgical loupes offer magnification of 3.5-5x.

Primary outcomes

  1. Positive sperm retrieval

    Time frame: immediately after the surgery

    Number of sperm retrieval

  2. 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

  3. Johnsen score

    Time frame: immediately after the surgery

    Number according to Johnsen score

  4. Sperm vials stored

    Time frame: immediately after the surgery

    Number

Secondary outcomes

  1. Operative time

    Time frame: immediately after the surgery

    Minutes

  2. Complications

    Time frame: through study completion, an average of 1 year

    Clavien dindo classification

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 25, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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