The Comparison of Diagnostic TESE and TESA in Non-obstructive Azoospermic

Phase 2

Completed

• Conditions: Infertility
• Interventions: Procedure: testicular sperm aspiration; Procedure: extaction; Procedure: testicular sperm extraction

• Registration Number: NCT01210326
• Lead Sponsor: Royan Institute

Brief Summary

Azoospermia , as the name suggests , refers to the condition in which there are no sperm in the semen. This diagnosis can come as a rude shock, because most men with a zero sperm count have normal libido; normal sexual function; and their semen looks completely normal too. The diagnosis can only be made by examining the semen under a microscope in the laboratory.Men with non-obstructive azoospermia have a normal passageway, but abnormal testicular function, and their testes do not produce sperm normally. Some of these men may have small testes on clinical examination. The testicular failure may be partial, which means that only a few areas of the testes produce sperm, but this sperm production is not enough for it to be ejaculated. Other men may have complete testicular failure, which means there is no sperm production at all in the entire testes. The only way to differentiate between complete and partial testicular failure is by doing multiple testicular micro-biopsies to sample different areas of the testes and send them for pathological examination. This technique is called TESA, or testicular sperm aspiration ( also known as TESE, or testicular sperm extraction) or mTESE ( micro-testicular sperm extraction).

Detailed Description

This study was performed on 180 men with non-obstructive azoospermia (NOA), referring to royan infertility center, according to inclusion and exclusion criteria. Testis selection (right and left) and techniques (TESE or TESA) were performed randomly in patients. For every patient based on random order, TESA or TESE was performed as the following procedures. The testis was aspirated at three separated sites (upper, middle and lower pole), using 20 ml syringe and 18-gauge needle or testicular biopsy (TESE) was taken from the same 3 sites.

Study Timeline

• Status Verified: 2008-08
• Study Start: 2009-09
• Primary Completion: 2010-07
• Study Completion: 2010-09
• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-27
• Study First Posted: 2010-09-28
• Last Update Submitted: 2011-07-14
• Last Update Posted: 2011-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 180

Inclusion Criteria

• Non obstructive Azoospermia
• No Previous biopsy

Exclusion Criteria

• Atrophic testis
• FSH levels more than 4 times normal range

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aspiration	testicular sperm aspiration	90 patients with non-obstructive azoospermi undergo testicular sperm aspiration
extraction	extaction	90 patients with non-obstructive azoospermi undergo testicular sperm extraction
extraction	testicular sperm extraction	90 patients with non-obstructive azoospermi undergo testicular sperm extraction

Primary Outcome Measures

Name	Time	Method
Sperm retrieval	6 months	comparision the success of sperm retrieval with TESE and TESA

Secondary Outcome Measures

Name	Time	Method
Side effects	6 months	Evaluate the side effects of the procedures like bleeding, inflammation, infection

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of