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| Name | Class |
|---|---|
| Federica Peretti | UNKNOWN |
| Ilaria Ferro | UNKNOWN |
| Natalia Plamadeala | UNKNOWN |
| Martina Scavone |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microscope | Device | The microscope provides a direct examination of the testicular parenchyma at 20-25x magnification. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Minutes | immediately after the surgery |
| Complications | Clavien dindo classification | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Molinette - AOU Città della Salute e della Scienza di Torino | Turin | 10126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33968665 | Background | Chen ML, Buncke GM, Turek PJ. Narrative review of the history of microsurgery in urological practice. Transl Androl Urol. 2021 Apr;10(4):1780-1791. doi: 10.21037/tau-20-1441. | |
| 26263080 | Background | 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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| ID | Term |
|---|---|
| C564665 | Azoospermia, Nonobstructive |
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| UNKNOWN |
| Luca Boeri | UNKNOWN |
| Marco Falcone | UNKNOWN |
| Lorenzo Cirigliano | UNKNOWN |
| Valentina Parolin | UNKNOWN |
| Emanuele Zupo | UNKNOWN |
| Paolo Gontero | UNKNOWN |
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
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| Surgical loupes | Device | Surgical loupes offer magnification of 3.5-5x. |
|
| 28904907 | Background | 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. |
| 28361811 | Background | 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. |
| 37322566 | Background | Pozzi E, Raffo M, Negri F, Boeri L, Sacca A, Belladelli F, Cilio S, Ventimiglia E, d'Arma A, Pagliardini L, Vigano P, Pontillo M, Luciano R, Colecchia M, Montorsi F, Alfano M, Salonia A. Anti-Mullerian hormone predicts positive sperm retrieval in men with idiopathic non-obstructive azoospermia-findings from a multi-centric cross-sectional study. Hum Reprod. 2023 Aug 1;38(8):1464-1472. doi: 10.1093/humrep/dead125. |
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| 31999885 | Background | Boeri L, Palmisano F, Preto M, Sibona M, Capogrosso P, Franceschelli A, Ruiz-Castane E, Sarquella-Geli J, Bassas-Arnau L, Scroppo FI, Sacca A, Gentile G, Falcone M, Timpano M, Ceruti C, Gadda F, Trost L, Colombo F, Rolle L, Gontero P, Montorsi F, Sanchez-Curbelo J, Salonia A, Montanari E. Sperm retrieval rates in non-mosaic Klinefelter patients undergoing testicular sperm extraction: What expectations do we have in the real-life setting? Andrology. 2020 May;8(3):680-687. doi: 10.1111/andr.12767. Epub 2020 Feb 16. |
| 9763095 | Background | Ostad M, Liotta D, Ye Z, Schlegel PN. Testicular sperm extraction for nonobstructive azoospermia: results of a multibiopsy approach with optimized tissue dispersion. Urology. 1998 Oct;52(4):692-6. doi: 10.1016/s0090-4295(98)00322-7. |
| 32558292 | Background | 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. |
| 36303631 | Background | 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. |
| 7824606 | 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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| 35887821 | Background | Falcone M, Boeri L, Timpano M, Cirigliano L, Preto M, Russo GI, Peretti F, Ferro I, Plamadeala N, Gontero P. Combined Trifocal and Microsurgical Testicular Sperm Extraction Enhances Sperm Retrieval Rate in Low-Chance Retrieval Non-Obstructive Azoospermia. J Clin Med. 2022 Jul 13;11(14):4058. doi: 10.3390/jcm11144058. |
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