TESE and Non Obstructive Azoospermia

NCT03146260 | Unknown DMC

• 1 other identifier: IRB000087987
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Azoospermia, Nonobstructive

Keywords

TESE; Sperm retreival; Azoospermia; FSH; LH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Complications

  within three months

• sperm retreival rate

  within procedure by biological search for sperms in retrieved specimens.

Study Arms (2)

Conventional TESE

EXPERIMENTAL

Conventional testicular sperm extraction (TESE) will be done under anesthesia through small vertical incision in the median raphe, skin, dartos and tunica vaginalis is opened to expose tunica albuginea. The tunica albuginea is incised for about 4mm at the upper pole near the head of epididymis.

Procedure: Conventional TESE

Microdissection TESE

EXPERIMENTAL

Microdissection testicular sperm extraction (TESE)will be carried under anesthesia micro TESE will be through a transverse incision of the testis covering three-quarters of its circumference, according to a line preserving as much as possible the predominantly transversal sub albugineal vessels. The testis will be opened like a book by gently separating the lobular tissue of both sides. Then, the tissue will be examined under the microscope at ×10-24 magnification to search for areas with dilated whitish tubules, from which numerous microretrievals will be performed.

Procedure: Microdissection TESE

Interventions

Conventional TESE PROCEDURE

usual procedure for sperm extraction

Also known as: OrdinaryTESE

Conventional TESE

Microdissection TESE PROCEDURE

Procedure of extraction is performed under the operating microscope

Also known as: Micro TESE

Microdissection TESE

Eligibility Criteria

• Age: 20 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All infertile males with non-obstructive azoospermia

You may not qualify if:

• Patient with obstructive azoospermia:
• Normal FSH
• Dilated seminal vesicle or ejaculatory duct

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 27406950 BACKGROUND

• 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.

  PMID: 22583840 BACKGROUND

MeSH Terms

Conditions

Azoospermia, Nonobstructive; Azoospermia

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Alaa E Abd El moneim, MD

  Professor of Urology

  STUDY CHAIR

Central Study Contacts

Mohammad A Saad, Msc

CONTACT

01002438659; dr.abas85@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: May 6, 2017
• First Posted: May 9, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 29, 2017

Record last verified: 2017-08