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Completed

NCT Number: NCT01210326

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

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).

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Key information

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non obstructive Azoospermia
  • No Previous biopsy

Exclusion criteria

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

Treatment and study plan

extaction

Procedure

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

Other names: Tecnique comparision

testicular sperm extraction

Procedure

testicular sperm extraction

Other names: sperm extraction

testicular sperm aspiration

Procedure

testicular sperm aspiration

Other names: sperm aspiration

Primary outcomes

  1. Sperm retrieval

    Time frame: 6 months

    comparision the success of sperm retrieval with TESE and TESA

Secondary outcomes

  1. Side effects

    Time frame: 6 months

    Evaluate the side effects of the procedures like bleeding, inflammation, infection

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 28, 2010
Registry last updated
Jul 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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