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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00484081
First Posted: June 8, 2007
Last Update Posted: June 8, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Clinic and Research Center in Human Reproduction Roger Abdelmassih
  Purpose

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.


Condition Intervention
Azoospermia Infertility Procedure: Microdissection Testicular Sperm Extraction Procedure: ICSI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Microdissection Testicular Sperm Extraction in Non-Obstructive Azoospermic Men and Their IVF-ICSI Related Outcomes at ART Treatment.

Further study details as provided by Clinic and Research Center in Human Reproduction Roger Abdelmassih:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 53
Study Start Date: June 2005
Study Completion Date: October 2006
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484081


Locations
Brazil
Clinic and Research Center in Human Reproduction Roger Abdelmassih
São Paulo, SP, Brazil, 01431-000
Sponsors and Collaborators
Clinic and Research Center in Human Reproduction Roger Abdelmassih
Investigators
Principal Investigator: Pedro Ravizzini, Dr. Clinic and Research Center in Human Reproduction Roger Abdelmassih
  More Information

ClinicalTrials.gov Identifier: NCT00484081     History of Changes
Other Study ID Numbers: RA9969
First Submitted: June 6, 2007
First Posted: June 8, 2007
Last Update Posted: June 8, 2007
Last Verified: June 2007

Keywords provided by Clinic and Research Center in Human Reproduction Roger Abdelmassih:
TESE
NON-OBSTRUCTIVE
MICRODISSECTION
AZOOSPERMIA
ICSI

Additional relevant MeSH terms:
Infertility
Azoospermia
Genital Diseases, Male
Genital Diseases, Female
Infertility, Male