Use of Testicular Spermatozoa in Non-azoospermic Patients

NCT ID: NCT05203211

Last Updated: 2022-01-24

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

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-04-02

Brief Summary

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Use of testicular spermatozoa in non-azoospermic patients.

Detailed Description

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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.

Conditions

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Male Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Men who have undergone icsi from ejaculated semen

No interventions assigned to this group

Men who have undergone icsi from testicular sperm

Testicular sperm extraction (TESE)

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Clinico Humanitas

Rozzano, Milano, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Paolo Emanuele Levi Setti, MD

Role: primary

References

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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. doi: 10.1016/s1472-6483(10)60710-9.

Reference Type BACKGROUND
PMID: 17697499 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25971317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34233843 (View on PubMed)

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. doi: 10.1093/humupd/dmm029. Epub 2007 Sep 24.

Reference Type BACKGROUND
PMID: 17895238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29777145 (View on PubMed)

Other Identifiers

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XXX/2022

Identifier Type: -

Identifier Source: org_study_id

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