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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06702397

Enrollment

Registered

2024-11-25

Start date

2022-03-01

Completion date

2024-04-30

Last updated

2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Azoospermia, Nonobstructive

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.

Interventions

DEVICEMicroscope

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

DEVICESurgical loupes

Surgical loupes offer magnification of 3.5-5x.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Randomized multi-center controlled trial comparing 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) in terms of surgical outcomes and sperm retrieval rates

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Positive sperm retrieval	immediately after the surgery	Number of sperm retrieval
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
Johnsen score	immediately after the surgery	Number according to Johnsen score
Sperm vials stored	immediately after the surgery	Number

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026