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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484081
• Other study ID #: RA9969
• Status: Completed
• Phase: N/A
• First received: June 6, 2007
• Last updated: June 7, 2007
• Start date: June 2005
• Est. completion date: October 2006

Study information

• Verified date: June 2007
• Source: Clinic and Research Center in Human Reproduction Roger Abdelmassih
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Azoospermia
• Infertility

Intervention

Procedure:
• Microdissection Testicular Sperm Extraction

• ICSI

Locations

Country	Name	City	State
Brazil	Clinic and Research Center in Human Reproduction Roger Abdelmassih	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Clinic and Research Center in Human Reproduction Roger Abdelmassih

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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