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

NCT01210326 | Completed Phase 2 DMC

• 1 other identifier: Royan-Emb-009
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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).

Conditions

Infertility

Keywords

TESE; TESA; non obstructive; azoospermi

Outcome Measures

Primary Outcomes (1)

• Sperm retrieval

  comparision the success of sperm retrieval with TESE and TESA

  6 months

Secondary Outcomes (1)

• Side effects

  6 months

Study Arms (2)

aspiration

EXPERIMENTAL

90 patients with non-obstructive azoospermi undergo testicular sperm aspiration

Procedure: testicular sperm aspiration

extraction

EXPERIMENTAL

90 patients with non-obstructive azoospermi undergo testicular sperm extraction

Procedure: extaction; Procedure: testicular sperm extraction

Interventions

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

Also known as: Tecnique comparision

extraction

testicular sperm extraction PROCEDURE

testicular sperm extraction

Also known as: sperm extraction

extraction

testicular sperm aspiration PROCEDURE

testicular sperm aspiration

Also known as: sperm aspiration

aspiration

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Non obstructive Azoospermia
• No Previous biopsy

You may not qualify if:

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

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

• Royan Institute

MeSH Terms

Conditions

Infertility

Interventions

Sperm Retrieval

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Tissue and Organ Harvesting; Transplantation; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• hamid gourabi, PhD

  President of Royan Institute

  STUDY CHAIR

• Jalil Hosseini, MD

  urology investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 27, 2010
• First Posted: September 28, 2010
• Study Start: September 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 15, 2011

Record last verified: 2008-08

Locations

IR (1)