Clinical trial NCT03146260: TESE and Non Obstructive Azoospermia
Official title: Predictors for Successful Sperm Reterival by Testicular Sperm Extraxtion(TESE) in Patients With Non Obstructive Azospermia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Azoospermia, Nonobstructive
Keywords: TESE
Sperm retreival
Azoospermia
FSH
LH
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 148
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: In Assiut university

Eligibility criteria: Inclusion Criteria:

* All infertile males with non-obstructive azoospermia

Exclusion Criteria:

* Patient with obstructive azoospermia:

  * Normal FSH
  * Dilated seminal vesicle or ejaculatory duct

Primary outcomes:
measure: prediction model for success of sperm retrieval by TESE in non obstructive azospermic patients
timeFrame: within one hour from the start of the procedure .
Secondary outcomes:
measure: Complications
timeFrame: within three months
measure: sperm retreival rate
timeFrame: within procedure by biological search for sperms in retrieved specimens.
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Urology
name: Alaa E Abd El moneim, MD
role: STUDY_CHAIR
References:
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.
citation: 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.