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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
extaction
testicular sperm extraction
testicular sperm aspiration
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring TESE, TESA, non obstructive, azoospermi

Eligibility Criteria

20 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Non obstructive Azoospermia
  • No Previous biopsy

Exclusion Criteria:

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

Sites / Locations

  • Royan Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

aspiration

extraction

Arm Description

90 patients with non-obstructive azoospermi undergo testicular sperm aspiration

90 patients with non-obstructive azoospermi undergo testicular sperm extraction

Outcomes

Primary Outcome Measures

Sperm retrieval
comparision the success of sperm retrieval with TESE and TESA

Secondary Outcome Measures

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

Full Information

First Posted
September 27, 2010
Last Updated
July 14, 2011
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01210326
Brief Title
The Comparison of Diagnostic TESE and TESA in Non-obstructive Azoospermic
Official Title
The Comparison of Diagnostic Testicular Sperm Extraction(TESE) and Testicular Sperm Aspiration(TESA) in Non-obstructive Azoospermic Patients a Randomized Clinical Trial Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
TESE, TESA, non obstructive, azoospermi

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aspiration
Arm Type
Experimental
Arm Description
90 patients with non-obstructive azoospermi undergo testicular sperm aspiration
Arm Title
extraction
Arm Type
Experimental
Arm Description
90 patients with non-obstructive azoospermi undergo testicular sperm extraction
Intervention Type
Procedure
Intervention Name(s)
extaction
Other Intervention Name(s)
Tecnique comparision
Intervention Description
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
Intervention Name(s)
testicular sperm extraction
Other Intervention Name(s)
sperm extraction
Intervention Description
testicular sperm extraction
Intervention Type
Procedure
Intervention Name(s)
testicular sperm aspiration
Other Intervention Name(s)
sperm aspiration
Intervention Description
testicular sperm aspiration
Primary Outcome Measure Information:
Title
Sperm retrieval
Description
comparision the success of sperm retrieval with TESE and TESA
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Side effects
Description
Evaluate the side effects of the procedures like bleeding, inflammation, infection
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non obstructive Azoospermia No Previous biopsy Exclusion Criteria: Atrophic testis FSH levels more than 4 times normal range
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hamid gourabi, PhD
Organizational Affiliation
President of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jalil Hosseini, MD
Organizational Affiliation
urology investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Links:
URL
http://www.royaninstitute.org
Description
Royan Institute

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

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