TESE and Non Obstructive Azoospermia

Not Applicable

• Conditions: Azoospermia, Nonobstructive
• Interventions: Procedure: Microdissection TESE; Procedure: Conventional TESE

• Registration Number: NCT03146260
• Lead Sponsor: Assiut University

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

Study Timeline

• Study First Submitted: 2017-05-06
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-09
• Status Verified: 2017-08
• Study Start: 2017-09
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-09-29
• Primary Completion: 2019-09
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 148

Inclusion Criteria

• All infertile males with non-obstructive azoospermia

Exclusion Criteria

• Patient with obstructive azoospermia:

  • Normal FSH
  • Dilated seminal vesicle or ejaculatory duct

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microdissection TESE	Microdissection TESE	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.
Conventional TESE	Conventional TESE	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.

Primary Outcome Measures

Name	Time	Method
prediction model for success of sperm retrieval by TESE in non obstructive azospermic patients	within one hour from the start of the procedure .	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.

Secondary Outcome Measures

Name	Time	Method
Complications	within three months	Comparison between conventional TESE and micro TESE as regard complications
sperm retreival rate	within procedure by biological search for sperms in retrieved specimens.	comparison between two procedures as regard retrieval rate.