NCT06702397

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: A.O.U. Città della Salute e della Scienza · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Azoospermia, Nonobstructive

Interventions

Type	Name	Description
DEVICE	Microscope	The microscope provides a direct examination of the testicular parenchyma at 20-25x magnification.
DEVICE	Surgical loupes	Surgical loupes offer magnification of 3.5-5x.

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2024-11-25
• Last updated: 2024-11-25

Locations

1 site across 1 country: Italy