TESE and Non Obstructive Azoospermia

Azoospermia, Nonobstructive Clinical Trial

Official title:

Predictors for Successful Sperm Reterival by Testicular Sperm Extraxtion(TESE) in Patients With Non Obstructive Azospermia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03146260
• Other study ID #: IRB000087987
• Status: Not yet recruiting
• Phase: N/A
• First received: May 6, 2017
• Last updated: September 27, 2017
• Start date: September 2017
• Est. completion date: December 2019

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: Mohammad A Saad, Msc
• Phone: 01002438659
• Email: dr.abas85[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Azoospermia is complete absence of sperm in the ejaculate. It accounts for 10-15% of male infertility cases. It is classified as obstructive and non-obstructive azoospermia (NOA). NOA constitutes 60% of all cases of azoospermia. Testicular sperm extraction (TESE) for intracytoplas¬mic sperm injection (ICSI) was first introduced for treatment of obstructive azoospermia in 1993. Soon afterwards testicular sperm were retrieved successfully and used in ICSI in cases of NOA. In the NOA cases, TESE combined with ICSI has been proven to be an acceptable line of treatment. Microdissection TESE may have some theoretical benefits over conventional TESE, but uncertainty exists about its superiority. During a conventional TESE procedure, the testis is exposed through a small incision and one or multiple biopsies are taken blindly. Micro TESE was first introduced in 1999. In this technique, the tunica albuginea is widely opened and examination of the testicular tissue is carried out at 20-25× magnification under an operating microscope allowing visualization of whitish, larger and more opaque tubuli. The concept of this technique is that these tubuli are more likely to contain active spermatogenesis. also no secure clinical predictors of (SR) are demonstrated for both procedures.The recovery of spermatozoa is successful in only 50% of cases and therefore the ability to predict those patients with a high probability of achieving a successful sperm retrieval would be of great value in counselling the patient and his partner . There is no single clinical finding or investigation that can accurately predict the outcome of TESE.An unsuccessful sperm recovery has important emotional and financial implications so objective counselling based on predictive factors may offer realistic expectations for both the couple and physician.

Description:

In Assiut university

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 148
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• All infertile males with non-obstructive azoospermia

Exclusion Criteria:

• Patient with obstructive azoospermia:

• Normal FSH

• Dilated seminal vesicle or ejaculatory duct

Related Conditions & MeSH terms

• Azoospermia
• Azoospermia, Nonobstructive

Intervention

Procedure:
• Conventional TESE
usual procedure for sperm extraction
• Microdissection TESE
Procedure of extraction is performed under the operating microscope

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Abdel Raheem A, Garaffa G, Rushwan N, De Luca F, Zacharakis E, Abdel Raheem T, Freeman A, Serhal P, Harper JC, Ralph D. Testicular histopathology as a predictor of a positive sperm retrieval in men with non-obstructive azoospermia. BJU Int. 2013 Mar;111(3):492-9. doi: 10.1111/j.1464-410X.2012.11203.x. Epub 2012 May 15. — View Citation

Cissen M, Meijerink AM, D'Hauwers KW, Meissner A, van der Weide N, Mochtar MH, de Melker AA, Ramos L, Repping S, Braat DD, Fleischer K, van Wely M. Prediction model for obtaining spermatozoa with testicular sperm extraction in men with non-obstructive azoospermia. Hum Reprod. 2016 Sep;31(9):1934-41. doi: 10.1093/humrep/dew147. Epub 2016 Jul 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prediction model for success of sperm retrieval by TESE in non obstructive azospermic patients	Descriptive statistics for the studied sample will be used as needed. Evaluation of the predictors of sperm retrieval success will be done through a binary logistic regression analysis.	within one hour from the start of the procedure .
Secondary	Complications	Comparison between conventional TESE and micro TESE as regard complications	within three months
Secondary	sperm retreival rate	comparison between two procedures as regard retrieval rate.	within procedure by biological search for sperms in retrieved specimens.