Microdissection Testicular Sperm Extraction (MicroTESE) and IVF-ICSI Outcome in Non-Obstructive Azoospermia (NOA)

June 7, 2007 updated by: Clinic and Research Center in Human Reproduction Roger Abdelmassih

Prospective Evaluation of Microdissection Testicular Sperm Extraction in Non-Obstructive Azoospermic Men and Their IVF-ICSI Related Outcomes at ART Treatment.

We evaluated the application of surgical testicular exploration with the aid of a microscope (MictoTESE) to increase the chances of obtaining sperm in men with impaired sperm production, a condition known as non-obstructive azoospermia.

We also evaluated the outcomes of these couples when the sperm obtained were used in ICSI (Intracytoplasmic Sperm Injection) during assisted reproductive technology treatment.

We believe that excellent results may be obtained with the use of the following techniques in the treatment of couples where non-obstructive azoospermia is a significant cause.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Men diagnosed with non-obstructive azoospermia and seeking assisted reproductive technology treatment (ART) are candidates for surgical sperm retrieval with the aid of microdissection. We believe that this approach may currently be the best option for these subjects.

We evaluated our surgical sperm retrieval rate associated to their serum LH, FSH, TOTAL TESTOTERONE and PROLACTIN levels, pre-operative testicular volume and also compared to the post-operative histological analysis of fixed testicular tissue specimens collected during the procedure, stained with haematoxylin and eosin.

We also evaluated the outcomes using ICSI based ART for these couples observing mean ICSI and fertilized oocytes, number and quality of embryos transferred, implantation and pregnancy rates.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

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

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 01431-000
        • Clinic and Research Center in Human Reproduction Roger Abdelmassih

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men undergoing ART treatment with clinical diagnosis of non-obstructive azoospermia.
  • Female partner undergoing ICSI based ART treatment

Exclusion Criteria:

  • Men where non-obstructive azoospermia was not confirmed based on histological analysis of fixed testicular tissue specimens collected by open surgical testicular biopsy and stained with haematoxylin and eosin.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sperm retrieval rate,mean male and female partner age,mean ICSI and fertilized oocytes, implantation, pregnancy and miscarriage rates.Testicular histology was also compared.
Time Frame: 17 months
17 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Sperm retrieval associated to pre-operative serum FSH, LH, Total Testosterone,Prolactin, testicular volume and post-operative testicular histology. ICSI and pregnancy results associated to sperm motility.
Time Frame: 17 months
17 months

Collaborators and Investigators

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

Sponsor

Clinic and Research Center in Human Reproduction Roger Abdelmassih

Investigators

  • Principal Investigator: Pedro Ravizzini, Dr., Clinic and Research Center in Human Reproduction Roger Abdelmassih

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

June 1, 2005

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

June 6, 2007

First Submitted That Met QC Criteria

June 7, 2007

First Posted (Estimate)

June 8, 2007

Study Record Updates

Last Update Posted (Estimate)

June 8, 2007

Last Update Submitted That Met QC Criteria

June 7, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA9969

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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