- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03146260
TESE and Non Obstructive Azoospermia
September 27, 2017 updated by: Mohammad Abbass, Assiut University
Predictors for Successful Sperm Reterival by Testicular Sperm Extraxtion(TESE) in Patients With Non Obstructive Azospermia
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
In Assiut university
Study Type
Interventional
Enrollment (Anticipated)
148
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohammad A Saad, Msc
- Phone Number: 01002438659
- Email: dr.abas85@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- All infertile males with non-obstructive azoospermia
Exclusion Criteria:
Patient with obstructive azoospermia:
- Normal FSH
- Dilated seminal vesicle or ejaculatory duct
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
usual procedure for sperm extraction
Other Names:
|
Experimental: 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.
|
Procedure of extraction is performed under the operating microscope
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prediction model for success of sperm retrieval by TESE in non obstructive azospermic patients
Time Frame: 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.
|
within one hour from the start of the procedure .
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications
Time Frame: within three months
|
Comparison between conventional TESE and micro TESE as regard complications
|
within three months
|
sperm retreival rate
Time Frame: within procedure by biological search for sperms in retrieved specimens.
|
comparison between two procedures as regard retrieval rate.
|
within procedure by biological search for sperms in retrieved specimens.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Alaa E Abd El moneim, MD, Professor of Urology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2017
Primary Completion (Anticipated)
September 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
May 6, 2017
First Submitted That Met QC Criteria
May 8, 2017
First Posted (Actual)
May 9, 2017
Study Record Updates
Last Update Posted (Actual)
September 29, 2017
Last Update Submitted That Met QC Criteria
September 27, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB000087987
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Azoospermia, Nonobstructive
-
Acibadem UniversityCompletedAzoospermia, NonobstructiveTurkey
-
Hospices Civils de LyonNot yet recruitingAzoospermia, NonobstructiveFrance
-
Assiut UniversityUnknownAzoospermia, Nonobstructive
-
KK Women's and Children's HospitalCompletedAzoospermia, Nonobstructive | OligozoospermiaSingapore
-
IRCCS San RaffaeleRecruiting
-
Cairo UniversityCompletedVaricocele | Azoospermia, NonobstructiveEgypt
-
Peking University Third HospitalCompletedInfertility, Male | Azoospermia, NonobstructiveChina
-
University of PittsburghInfertility and IVF Center, St. Louis, MOActive, not recruitingInfertility, Male | Azoospermia, NonobstructiveUnited States
-
Stanford UniversityRecruitingMale Infertility | Azoospermia | Nonobstructive AzoospermiaUnited States
Clinical Trials on Conventional TESE
-
University Hospital, ToulouseTerminated
-
Istituto Clinico HumanitasRecruiting
-
Istituto Clinico HumanitasCompletedObstetric Complication | Non-obstructive Azoospermia | Obstructive Azoospermia
-
Assiut UniversityNot yet recruitingMale Infertility Due to Azoospermia
-
Cairo UniversityCompletedNon Obstructive AzoospermiaEgypt
-
Istanbul Demiroglu Bilim UniversityCompletedMuscle Weakness | Rehabilitation | Intensive Care Unit SyndromeTurkey
-
University of SalamancaRecruiting
-
Mennallah Ahmed Mohamed Anwar ElgendyNot yet recruiting
-
University of AarhusGCP-unit at Aarhus University Hospital, Aarhus, Denmark; Danish Classical Homeopathy... and other collaboratorsCompleted
-
Aveiro UniversityFundação para a Ciência e a TecnologiaCompletedLower Respiratory Tract InfectionsPortugal