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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 : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE May 13, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date August 24, 2021
Actual Study Start Date  ICMJE April 26, 2017
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Medical Results of Testicular Sperm Extraction by Conventional Surgery and Microsurgical Track
Official Title  ICMJE Comparison of Medical Results of Testicular Sperm Extraction by Conventional Surgery and Microsurgical Track
Brief Summary To compare motile sperm extraction rate between microTESE and conventional TESE in 18-50 years-old men with non obstructive azoospermia.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Azoospermia
Intervention  ICMJE
  • Procedure: conventional TESE
    usual procedure for sperm extraction
    Other Name: conventional surgery
  • Procedure: Micro TESE
    procedure of extraction is performed under the operating microscope
    Other Name: Microdissection surgery
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: conventional TESE
  • 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
    Intervention: Procedure: Micro TESE
Publications * Tsujimura A, Matsumiya K, Miyagawa Y, Tohda A, Miura H, Nishimura K, Koga M, Takeyama M, Fujioka H, Okuyama A. Conventional multiple or microdissection testicular sperm extraction: a comparative study. Hum Reprod. 2002 Nov;17(11):2924-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2016)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eric Huyghe, MD, PhD 33561771028 huyghe.e@chu-toulouse.fr
Contact: Thierry Almont almont.t@chu-toulouse.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02773498
Other Study ID Numbers  ICMJE RC31/15/7840
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Huyghe, MD, PhD U H Toulouse
PRS Account University Hospital, Toulouse
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP