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Comparison of Medical Results of Testicular Sperm Extraction by Conventional Surgery and Microsurgical Track (Microsperm)

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ClinicalTrials.gov Identifier: NCT02773498
Recruitment Status : Recruiting
First Posted : May 16, 2016
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
To compare motile sperm extraction rate between microTESE and conventional TESE in 18-50 years-old men with non obstructive azoospermia.

Condition or disease Intervention/treatment Phase
Azoospermia Procedure: conventional TESE Procedure: Micro TESE Not Applicable

Detailed Description:

About one in ten couples cannot have children without medical assistance. Male factors for infertility are identified in half cases with 10% azoospermia, non-obstructive in most cases. Up to date, testis surgical sperm retrieval for use in ICSI-IVF is the only possibility for those men to have children with their own sperm. Several options are available for surgically retrieving sperm from testis: During conventional testicular sperm extraction (cTESE), the testis is exposed through a small incision, then 1 or more biopsies are randomly made. Up to date, cTESE is considered as the gold-standard for sperm extraction in this population.

However, the success of surgical sperm extraction concerns a man out of two having cTESE for non-obstructive azoospermia.

On the other hand, Schlegel showed in 1997 that cTESE induces a significative loss of testicular tissue with possible impact on male endocrine balance with occurence of hematomas, inflammatory reshuffles and ischaemic lesions, compromising some regions in the testicular parenchyme. Another option for surgical sperm extraction is micro-surgery called microTESE (or µTESE). It consists in examining the testicular parenchyme under a high-power microscope (up to 25 magnification), screening for white opaque tubules with higher diameter which indicates possible active spermatogenesis. The benefits of µTESE are: (1) a better identification of sites of sperm production in the testis, (2) a better preservation of testicular vasculature decreasing the risk of postoperative hematoma or tissue ischemia and (3) excision of 3 to 10 times less tissue.

Nevertheless, no randomized studies have compared both techniques to validate such an assumption. In 2014, the results of a meta-analysis performed by Deruyver showed that, among the 7 original articles comparing cTESE to µTESE, 3 were retrospective studies and the remaining 4 prospective studies were not randomized.

It is highly unlikely that this better outcome is related to patient selection. Nevertheless, the relatively small number of studies comparing both methods makes it difficult to draw definitive conclusions This study is based on the hypothesis that µTESE is a superior technique than cTESE with a difference of 20% like observed in Deruyver's meta-analysis.

The principal objective is to compare motile sperm extraction rate between μTESE and cTESE in 18-50 years-old men with NOA.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Comparison of Medical Results of Testicular Sperm Extraction by Conventional Surgery and Microsurgical Track
Actual Study Start Date : April 26, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2022


Arm Intervention/treatment
Active Comparator: conventional TESE
Conventional multiple TESE is performed under general or locoregional anesthesia. Through a small vertical incision in the median scrotal raphe, the skin, dartos muscle, and tunica vaginalis are opened to expose the tunica albuginea. The tunica albuginea is ordinarily incised for about 4 mm at the medium region of the testis. A similar biopsy will be systematically performed in the contralateral testis. The biopsy is analyzed by the biologist in the theatre in order to precise if sufficient spermatozoa is retrieved.
Procedure: conventional TESE
usual procedure for sperm extraction
Other Name: conventional surgery

Experimental: micro TESE
Microdissection TESE is also performed under general or locoregional anesthesia. After the tunica albuginea is opened widely along the antiepididymal border, direct examination of the testicular parenchyma is performed under the operating microscope. An attempt is made to identify individual seminiferous tubules that are larger, more opaque and whiter than other tubules in the testicular parenchyma, which are considered to contain spermatozoa. The extracted tubules are analyzed by the biologist in the theatre. The procedure is terminated when sperm are retrieved or further biopsy is thought likely to jeopardize the blood supply of the testis. If all tubules are seen to have an identical morphological appearance, at least three samples (upper, middle, and lower) are obtained. A similar microTESE will be systematically performed in the contralateral testis
Procedure: Micro TESE
procedure of extraction is performed under the operating microscope
Other Name: Microdissection surgery




Primary Outcome Measures :
  1. sperm extraction [ Time Frame: time of surgery ]
    positivity (presence, coded 1) or negativity (absence, coded 0) of the sperm extraction, based on possibility of having at least 1 mobile sperm



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 2 consecutive spermograms (with ±3 months interval) confirming absence of sperm (azoospermia)
  • diagnosis of non-obstructive azoospermia on the basis of a complete history, physical examination, endocrine profile, ultrasound and chromosomal analysis

Exclusion Criteria:

  • History of previous testicular surgery, except orchiopexy for undescended testis.
  • Monochordy
  • Ultrasound revealed testicular nodule
  • Y chromosome microdeletions type AZFa and b.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773498


Contacts
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Contact: Eric Huyghe, MD, PhD 33561771028 huyghe.e@chu-toulouse.fr
Contact: Thierry Almont almont.t@chu-toulouse.fr

Locations
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France
University Hospital Not yet recruiting
Bordeaux, France, 33 000
Contact: Ludovic Ferretti, MD       ludovic.ferretti@gmail.com   
University Hospital Not yet recruiting
Lille, France, 59037
Contact: François Marcelli, MD       françois.marcelli@chru-lille.fr   
University Hospital Not yet recruiting
Lyon, France, 69437
Contact: Béatrice Cuzin, MD       beatrice.cuzin@chu-lyon.fr   
University Hospital Not yet recruiting
Paris, France, 75015
Contact: Nicolas Thiuonn, MD       nicolas.thiounn@aphp.fr   
University Hospital Not yet recruiting
Rouen, France, 76031
Contact: Louis Sibert, MD, PHD       louis.sibert@chu-rouen.fr   
University Hospital Recruiting
Toulouse, France, 31 059
Contact: Eric Huyghe, MD, PhD       huyghe.e@chu-toulouse.fr   
Contact: Thierry Almont       almont.t@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Eric Huyghe, MD, PhD U H Toulouse
Publications:
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02773498    
Other Study ID Numbers: RC31/15/7840
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Azoospermia
Infertility, Male
Infertility