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

NCT ID: NCT01210326

Last Updated: 2011-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-09-30

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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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aspiration

90 patients with non-obstructive azoospermi undergo testicular sperm aspiration

Group Type EXPERIMENTAL

testicular sperm aspiration

Intervention Type PROCEDURE

testicular sperm aspiration

extraction

90 patients with non-obstructive azoospermi undergo testicular sperm extraction

Group Type EXPERIMENTAL

extaction

Intervention Type 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

testicular sperm extraction

Intervention Type PROCEDURE

testicular sperm extraction

Interventions

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extaction

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

Intervention Type PROCEDURE

testicular sperm extraction

testicular sperm extraction

Intervention Type PROCEDURE

testicular sperm aspiration

testicular sperm aspiration

Intervention Type PROCEDURE

Other Intervention Names

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Tecnique comparision sperm extraction sperm aspiration

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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President of Royan Institute

Principal Investigators

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hamid gourabi, PhD

Role: STUDY_CHAIR

President of Royan Institute

Jalil Hosseini, MD

Role: PRINCIPAL_INVESTIGATOR

urology investigator

Locations

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Royan Institute

Tehran, , Iran

Site Status

Countries

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Iran

Related Links

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Other Identifiers

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Royan-Emb-009

Identifier Type: -

Identifier Source: org_study_id

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