Use of Testicular Spermatozoa in Non-azoospermic Patients

Male Infertility Clinical Trial

— NAZOSPERM  

Official title:

Use of Testicular Spermatozoa in Non-azoospermic Patients: Retrospective Analysis of a Single Center Experience.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05203211
• Other study ID #: XXX/2022
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: April 2, 2022

Study information

• Verified date: January 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Use of testicular spermatozoa in non-azoospermic patients.

Description:

The aim of the study is to evaluate the characteristics of couples whose male partner is offered TESE after the failure of previous ICSI technique performed with ejaculated semen. All couples in a third-level University affiliated centre, between January 2010 and January 2020, whose male partner were diagnosed with any type of oligospermia and underwent TESE after ICSI from ejaculated semen, were included in the analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• All patients undergone testiscular sperm extraction (TESE) after failure of ICSI with the use of ejaculated sperm

Exclusion Criteria:

• Female age >40 yo

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Procedure:
• Testicular sperm extraction (TESE)
During the procedure, the testis is exposed through a small incision and one or more biopsies are taken blindly. A vertical incision is made in the median raphe, skin, dartos and tunica vaginalis to expose tunica albuginea. The tunica albuginea is incised for about 4 mm at upper pole near the head of epididymis.

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Donoso P, Tournaye H, Devroey P. Which is the best sperm retrieval technique for non-obstructive azoospermia? A systematic review. Hum Reprod Update. 2007 Nov-Dec;13(6):539-49. Epub 2007 Sep 24. Review. — View Citation

Kang YN, Hsiao YW, Chen CY, Wu CC. Testicular sperm is superior to ejaculated sperm for ICSI in cryptozoospermia: An update systematic review and meta-analysis. Sci Rep. 2018 May 18;8(1):7874. doi: 10.1038/s41598-018-26280-0. — View Citation

Kendall Rauchfuss LM, Kim T, Bleess JL, Ziegelmann MJ, Shenoy CC. Testicular sperm extraction vs. ejaculated sperm use for nonazoospermic male factor infertility. Fertil Steril. 2021 Oct;116(4):963-970. doi: 10.1016/j.fertnstert.2021.05.087. Epub 2021 Jul 4. — View Citation

Ozmen B, Caglar GS, Koster F, Schopper B, Diedrich K, Al-Hasani S. Relationship between sperm DNA damage, induced acrosome reaction and viability in ICSI patients. Reprod Biomed Online. 2007 Aug;15(2):208-14. — View Citation

Samplaski MK, Dimitromanolakis A, Lo KC, Grober ED, Mullen B, Garbens A, Jarvi KA. The relationship between sperm viability and DNA fragmentation rates. Reprod Biol Endocrinol. 2015 May 14;13:42. doi: 10.1186/s12958-015-0035-y. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fertilization rate (FR)	Evaluate if there is a higher fertilization rate in male patients undergone TESE	10 years
Secondary	Blastulation rate (BR)	Evaluate if there is a higher blastulation rate in male patients undergone TESE	10 years
Secondary	Miscarriage rate (MR)	Evaluate if there is a lower miscarriage rate in male patients undergone TESE	10 years