Use of Testicular Spermatozoa in Non-azoospermic Patients

NCT05203211 | Unknown

• 1 other identifier: XXX/2022
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Use of testicular spermatozoa in non-azoospermic patients.

Conditions

Male Infertility

Outcome Measures

Primary Outcomes (1)

• fertilization rate (FR)

  Evaluate if there is a higher fertilization rate in male patients undergone TESE

  10 years

Secondary Outcomes (2)

• Blastulation rate (BR)

  10 years

• Miscarriage rate (MR)

  10 years

Study Arms (2)

Men who have undergone icsi from ejaculated semen

Men who have undergone icsi from testicular sperm

Procedure: Testicular sperm extraction (TESE)

Interventions

Testicular sperm extraction (TESE) 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.

Men who have undergone icsi from testicular sperm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• Female age \>40 yo

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 17697499 BACKGROUND

• 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.

  PMID: 25971317 BACKGROUND

• 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.

  PMID: 34233843 BACKGROUND

• 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.

  PMID: 17895238 BACKGROUND

• 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.

  PMID: 29777145 BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: January 1, 2022
• Primary Completion: March 1, 2022
• Study Completion: April 2, 2022
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)