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TESE and Non Obstructive Azoospermia

Primary Purpose

Azoospermia, Nonobstructive

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional TESE
Microdissection TESE
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Azoospermia, Nonobstructive focused on measuring TESE, Sperm retreival, Azoospermia, FSH, LH

Eligibility Criteria

20 Years - 55 Years (Adult)MaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Conventional TESE

    Microdissection TESE

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Complications
    Comparison between conventional TESE and micro TESE as regard complications
    sperm retreival rate
    comparison between two procedures as regard retrieval rate.

    Full Information

    First Posted
    May 6, 2017
    Last Updated
    September 27, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03146260
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2017 (Anticipated)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Azoospermia, Nonobstructive
    Keywords
    TESE, Sperm retreival, Azoospermia, FSH, LH

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    148 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional TESE
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Microdissection TESE
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional TESE
    Other Intervention Name(s)
    OrdinaryTESE
    Intervention Description
    usual procedure for sperm extraction
    Intervention Type
    Procedure
    Intervention Name(s)
    Microdissection TESE
    Other Intervention Name(s)
    Micro TESE
    Intervention Description
    Procedure of extraction is performed under the operating microscope
    Primary Outcome Measure Information:
    Title
    prediction model for success of sperm retrieval by TESE in non obstructive azospermic patients
    Description
    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.
    Time Frame
    within one hour from the start of the procedure .
    Secondary Outcome Measure Information:
    Title
    Complications
    Description
    Comparison between conventional TESE and micro TESE as regard complications
    Time Frame
    within three months
    Title
    sperm retreival rate
    Description
    comparison between two procedures as regard retrieval rate.
    Time Frame
    within procedure by biological search for sperms in retrieved specimens.

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammad A Saad, Msc
    Phone
    01002438659
    Email
    dr.abas85@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alaa E Abd El moneim, MD
    Organizational Affiliation
    Professor of Urology
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    27406950
    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.
    Results Reference
    background
    PubMed Identifier
    22583840
    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.
    Results Reference
    background

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    TESE and Non Obstructive Azoospermia

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