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

NCT06702397 | Completed

• 1 other identifier: 202/2022
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Azoospermia, Nonobstructive

Outcome Measures

Primary Outcomes (4)

• Positive sperm retrieval

  Number of sperm retrieval

  immediately after the surgery

• Histology

  Normal testicular biopsy or Hypospermatogenesis or Germ cell arrest or Sertoli cell-only syndrome or Seminiferous tubule hyalinization or CIS or Immature testis

  immediately after the surgery

• Johnsen score

  Number according to Johnsen score

  immediately after the surgery

• Sperm vials stored

  Number

  immediately after the surgery

Secondary Outcomes (2)

• Operative time

  immediately after the surgery

• Complications

  through study completion, an average of 1 year

Study Arms (2)

Microsurgical-assisted testicular sperm extraction (m-TeSE) - Group A

ACTIVE COMPARATOR

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).

Device: Microscope

Testicular sperm extraction performed with surgical loupes (l-TeSE) - Group B

ACTIVE COMPARATOR

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).

Device: Surgical loupes

Interventions

Microscope DEVICE

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

Microsurgical-assisted testicular sperm extraction (m-TeSE) - Group A

Surgical loupes DEVICE

Surgical loupes offer magnification of 3.5-5x.

Testicular sperm extraction performed with surgical loupes (l-TeSE) - Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males
• Diagnosis of non obstructive azoospermia who required m-TeSE.

You may not qualify if:

• 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

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead
• Federica Peretti: collaborator
• Ilaria Ferro: collaborator
• Natalia Plamadeala: collaborator
• Martina Scavone: collaborator
• Luca Boeri: collaborator
• Marco Falcone: collaborator
• Lorenzo Cirigliano: collaborator
• Valentina Parolin: collaborator
• Emanuele Zupo: collaborator
• Paolo Gontero: collaborator

Study Sites (1)

Molinette - AOU Città della Salute e della Scienza di Torino

Turin, 10126, Italy

Location

Related Publications (18)

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• Bernie AM, Mata DA, Ramasamy R, Schlegel PN. Comparison of microdissection testicular sperm extraction, conventional testicular sperm extraction, and testicular sperm aspiration for nonobstructive azoospermia: a systematic review and meta-analysis. Fertil Steril. 2015 Nov;104(5):1099-103.e1-3. doi: 10.1016/j.fertnstert.2015.07.1136. Epub 2015 Aug 8.

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• Flannigan R, Bach PV, Schlegel PN. Microdissection testicular sperm extraction. Transl Androl Urol. 2017 Aug;6(4):745-752. doi: 10.21037/tau.2017.07.07.

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• Li H, Chen LP, Yang J, Li MC, Chen RB, Lan RZ, Wang SG, Liu JH, Wang T. Predictive value of FSH, testicular volume, and histopathological findings for the sperm retrieval rate of microdissection TESE in nonobstructive azoospermia: a meta-analysis. Asian J Androl. 2018 Jan-Feb;20(1):30-36. doi: 10.4103/aja.aja_5_17.

  PMID: 28361811 BACKGROUND

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  PMID: 37322566 BACKGROUND

• Tournaye H, Liu J, Nagy PZ, Camus M, Goossens A, Silber S, Van Steirteghem AC, Devroey P. Correlation between testicular histology and outcome after intracytoplasmic sperm injection using testicular spermatozoa. Hum Reprod. 1996 Jan;11(1):127-32. doi: 10.1093/oxfordjournals.humrep.a019004.

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• Pozzi E, Boeri L, Capogrosso P, Palmisano F, Preto M, Sibona M, Franceschelli A, Ruiz-Castane E, Sarquella-Geli J, Bassas-Arnau L, Scroppo FI, Gentile G, Falcone M, Timpano M, Ceruti C, Gadda F, Colombo F, Rolle L, Gontero P, Montorsi F, Sanchez-Curbelo J, Montanari E, Salonia A. Rates of hypogonadism forms in Klinefelter patients undergoing testicular sperm extraction: A multicenter cross-sectional study. Andrology. 2020 Nov;8(6):1705-1711. doi: 10.1111/andr.12843. Epub 2020 Jul 3.

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• Vieira M, Bispo de Andrade MA, Santana-Santos E. Is testicular microdissection the only way to retrieve sperm for non-obstructive azoospermic men? Front Reprod Health. 2022 Aug 23;4:980824. doi: 10.3389/frph.2022.980824. eCollection 2022.

  PMID: 36303631 BACKGROUND

• Serletti JM, Deuber MA, Guidera PM, Reading G, Herrera HR, Reale VF, Wray RC Jr, Bakamjian VY. Comparison of the operating microscope and loupes for free microvascular tissue transfer. Plast Reconstr Surg. 1995 Feb;95(2):270-6. doi: 10.1097/00006534-199502000-00006.

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MeSH Terms

Conditions

Azoospermia, Nonobstructive

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Mirko Preto

Model Details: 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

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 25, 2024
• Study Start: March 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)