Use of Testicular Spermatozoa in Non-azoospermic Patients (NAZOSPERM)

January 10, 2022 updated by: Istituto Clinico Humanitas

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

Use of testicular spermatozoa in non-azoospermic patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milano
      • Rozzano, Milano, Italy, 20089

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Men who have undergone icsi from ejaculated semen
Men who have undergone icsi from testicular sperm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fertilization rate (FR)
Time Frame: 10 years
Evaluate if there is a higher fertilization rate in male patients undergone TESE
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blastulation rate (BR)
Time Frame: 10 years
Evaluate if there is a higher blastulation rate in male patients undergone TESE
10 years
Miscarriage rate (MR)
Time Frame: 10 years
Evaluate if there is a lower miscarriage rate in male patients undergone TESE
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

April 2, 2022

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

January 10, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XXX/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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