NCT00484081

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2007

Completed
Last Updated

June 8, 2007

Status Verified

June 1, 2007

First QC Date

June 6, 2007

Last Update Submit

June 7, 2007

Conditions

AzoospermiaInfertility

Keywords

TESENON-OBSTRUCTIVEMICRODISSECTIONAZOOSPERMIAICSI

Outcome Measures

Primary Outcomes (1)

  • Sperm retrieval rate,mean male and female partner age,mean ICSI and fertilized oocytes, implantation, pregnancy and miscarriage rates.Testicular histology was also compared.

    17 months

Secondary Outcomes (1)

  • 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.

    17 months

Interventions

Microdissection Testicular Sperm ExtractionPROCEDURE
ICSIPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic and Research Center in Human Reproduction Roger Abdelmassih

São Paulo, São Paulo, 01431-000, Brazil

Location

MeSH Terms

Conditions

AzoospermiaInfertility

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Pedro Ravizzini, Dr.

    Clinic and Research Center in Human Reproduction Roger Abdelmassih

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2007

First Posted

June 8, 2007

Study Start

June 1, 2005

Study Completion

October 1, 2006

Last Updated

June 8, 2007

Record last verified: 2007-06

Locations

BR(1)