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TESE and Non Obstructive Azoospermia

A

Assiut University

Status

Unknown

Conditions

Azoospermia, Nonobstructive

Treatments

Procedure: Conventional TESE
Procedure: Microdissection TESE

Study type

Interventional

Funder types

Other

Identifiers

NCT03146260
IRB000087987

Details and patient eligibility

About

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.

Full description

In Assiut university

Enrollment

148 estimated patients

Sex

Male

Ages

20 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All infertile males with non-obstructive azoospermia

Exclusion criteria

  • Patient with obstructive azoospermia:

    • Normal FSH
    • Dilated seminal vesicle or ejaculatory duct

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

148 participants in 2 patient groups

Conventional TESE
Experimental group
Description:
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.
Treatment:
Procedure: Conventional TESE
Microdissection TESE
Experimental group
Description:
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.
Treatment:
Procedure: Microdissection TESE

Trial contacts and locations

0

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Central trial contact

Mohammad A Saad, Msc

Data sourced from clinicaltrials.gov

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