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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Comparison of Diagnostic Testicular Sperm Extraction(TESE) and Testicular Sperm Aspiration(TESA) in Non-obstructive Azoospermic Patients a Randomized Clinical Trial Study

Conditions
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Infertility

Intervention / Treatment
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* Procedure: extaction
* Procedure: testicular sperm extraction
* Procedure: testicular sperm aspiration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non obstructive Azoospermia No Previous biopsy Exclusion Criteria: Atrophic testis FSH levels more than 4 times normal range

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aspiration<br>90 patients with non-obstructive azoospermi undergo testicular sperm aspiration | Procedure: testicular sperm aspiration<br>* testicular sperm aspiration<br>* Other names: sperm aspiration;|
| Experimental: extraction<br>90 patients with non-obstructive azoospermi undergo testicular sperm extraction | Procedure: extaction<br>* TESE (testicular sperm extraction), which is actually a surgical biopsy of the testis; or TESA (testicular sperm aspiration), which is performed by sticking a needle in the testis and aspirating fluid and tissue with negative pressure<br>* Other names: Tecnique comparision;Procedure: testicular sperm extraction<br>* testicular sperm extraction<br>* Other names: sperm extraction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm retrieval | comparision the success of sperm retrieval with TESE and TESA | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | Evaluate the side effects of the procedures like bleeding, inflammation, infection | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TESE, TESA, non obstructive, azoospermi