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

Primary Purpose

Azoospermia, Infertility

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Microdissection Testicular Sperm Extraction

ICSI

About this trial

This is an interventional treatment trial for Azoospermia focused on measuring TESE, NON-OBSTRUCTIVE, MICRODISSECTION, AZOOSPERMIA, ICSI

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Clinic and Research Center in Human Reproduction Roger Abdelmassih

Outcomes

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.

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.

Full Information

NCT ID

NCT00484081

First Posted

June 6, 2007

Last Updated

June 7, 2007

Sponsor

Clinic and Research Center in Human Reproduction Roger Abdelmassih

1. Study Identification

Unique Protocol Identification Number

NCT00484081

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2007

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Clinic and Research Center in Human Reproduction Roger Abdelmassih

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Azoospermia, Infertility

Keywords

TESE, NON-OBSTRUCTIVE, MICRODISSECTION, AZOOSPERMIA, ICSI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Microdissection Testicular Sperm Extraction

Intervention Type

Procedure

Intervention Name(s)

ICSI

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Time Frame

17 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pedro Ravizzini, Dr.

Organizational Affiliation

Clinic and Research Center in Human Reproduction Roger Abdelmassih

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinic and Research Center in Human Reproduction Roger Abdelmassih

City

São Paulo

State/Province

ZIP/Postal Code

01431-000

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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