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

NCT ID: NCT06702397

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-04-30

Brief Summary

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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

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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

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Azoospermia, Nonobstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Microscope

Intervention Type DEVICE

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

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).

Group Type ACTIVE_COMPARATOR

Surgical loupes

Intervention Type DEVICE

Surgical loupes offer magnification of 3.5-5x.

Interventions

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Microscope

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

Intervention Type DEVICE

Surgical loupes

Surgical loupes offer magnification of 3.5-5x.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Federica Peretti

UNKNOWN

Sponsor Role collaborator

Ilaria Ferro

UNKNOWN

Sponsor Role collaborator

Natalia Plamadeala

UNKNOWN

Sponsor Role collaborator

Martina Scavone

UNKNOWN

Sponsor Role collaborator

Luca Boeri

UNKNOWN

Sponsor Role collaborator

Marco Falcone

UNKNOWN

Sponsor Role collaborator

Lorenzo Cirigliano

UNKNOWN

Sponsor Role collaborator

Valentina Parolin

UNKNOWN

Sponsor Role collaborator

Emanuele Zupo

UNKNOWN

Sponsor Role collaborator

Paolo Gontero

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Mirko Preto

Doctor Mirko Preto

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Molinette - AOU Città della Salute e della Scienza di Torino

Turin, , Italy

Site Status

Countries

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Italy

References

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Other Identifiers

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202/2022

Identifier Type: -

Identifier Source: org_study_id

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