The Comparison of Diagnostic TESE and TESA in Non-obstructive Azoospermic
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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 |
- Sperm retrieval [ Time Frame: 6 months ] [ Designated as safety issue: No ]comparision the success of sperm retrieval with TESE and TESA
- 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 |
Inclusion Criteria:
- Non obstructive Azoospermia
- No Previous biopsy
Exclusion Criteria:
- Atrophic testis
- FSH levels more than 4 times normal range
Contacts and Locations| Iran, Islamic Republic of | |
| Royan Institute | |
| Tehran, Iran, Islamic Republic of | |
| 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 May 23, 2013