Microdissection Testicular Sperm Extraction (MicroTESE) and IVF-ICSI Outcome in Non-Obstructive Azoospermia (NOA)
|First Received Date ICMJE||June 6, 2007|
|Last Updated Date||June 7, 2007|
|Start Date ICMJE||June 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00484081 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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 ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Microdissection Testicular Sperm Extraction (MicroTESE) and IVF-ICSI Outcome in Non-Obstructive Azoospermia (NOA)|
|Official Title ICMJE||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.
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 ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||October 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Brazil|
|NCT Number ICMJE||NCT00484081|
|Other Study ID Numbers ICMJE||RA9969|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Clinic and Research Center in Human Reproduction Roger Abdelmassih|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Clinic and Research Center in Human Reproduction Roger Abdelmassih|
|Verification Date||June 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP