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

Not Applicable

Completed

• Conditions: Azoospermia, Nonobstructive

• Registration Number: NCT06702397
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

Brief 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.

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-11
• Study First Submitted: 2024-11-03
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Histology	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
Positive sperm retrieval	immediately after the surgery	Number of sperm retrieval
Johnsen score	immediately after the surgery	Number according to Johnsen score
Sperm vials stored	immediately after the surgery	Number

Secondary Outcome Measures

Name	Time	Method
Operative time	immediately after the surgery	Minutes
Complications	through study completion, an average of 1 year	Clavien dindo classification

Trial Locations

Locations (1)

Molinette - AOU Città della Salute e della Scienza di Torino; 🇮🇹 Turin, Italy