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

Royan Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Infertility

Treatments: Procedure: testicular sperm aspiration; Procedure: extaction; Procedure: testicular sperm extraction

Study type: Interventional

Funder types: Other

Identifiers

NCT01210326

Royan-Emb-009

Details and patient eligibility

About

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).

Full 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.

Enrollment: 180 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non obstructive Azoospermia
• No Previous biopsy

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

aspiration

Experimental group

Description:

90 patients with non-obstructive azoospermi undergo testicular sperm aspiration

Treatment:

Procedure: testicular sperm aspiration

extraction

Experimental group

Description:

90 patients with non-obstructive azoospermi undergo testicular sperm extraction

Treatment:

Procedure: testicular sperm extraction

Procedure: extaction