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

This study has been completed.
Sponsor:
Information provided by:
Royan Institute
ClinicalTrials.gov Identifier:
NCT01210326
First received: September 27, 2010
Last updated: July 14, 2011
Last verified: August 2008
  Purpose

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).


Condition Intervention Phase
Infertility
Procedure: extaction
Procedure: testicular sperm extraction
Procedure: testicular sperm aspiration
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Sperm retrieval [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    comparision the success of sperm retrieval with TESE and TESA


Secondary Outcome Measures:
  • Side effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Evaluate the side effects of the procedures like bleeding, inflammation, infection


Enrollment: 180
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aspiration
90 patients with non-obstructive azoospermi undergo testicular sperm aspiration
Procedure: testicular sperm aspiration
testicular sperm aspiration
Other Name: sperm aspiration
Experimental: extraction
90 patients with non-obstructive azoospermi undergo testicular sperm extraction
Procedure: 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
Other Name: Tecnique comparision
Procedure: testicular sperm extraction
testicular sperm extraction
Other Name: 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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non obstructive Azoospermia
  • No Previous biopsy

Exclusion Criteria:

  • Atrophic testis
  • FSH levels more than 4 times normal range
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210326

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: hamid gourabi, PhD President of Royan Institute
Principal Investigator: Jalil Hosseini, MD urology investigator
  More Information

Additional Information:
No publications provided

Responsible Party: Hamid Gourabi,President of Royan institute, President of Royan Institute
ClinicalTrials.gov Identifier: NCT01210326     History of Changes
Other Study ID Numbers: Royan-Emb-009
Study First Received: September 27, 2010
Last Updated: July 14, 2011
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
TESE
TESA
non obstructive
azoospermi

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 28, 2014