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

January 2, 2024 updated by: University Hospital, Toulouse
To compare mobile sperm extraction rate between microTESE and conventional TESE in 18-50 years-old men with non obstructive azoospermia.

Study Overview

Status

Terminated

Conditions

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

Interventional

Enrollment (Actual)

50

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

Study Contact Backup

Study Locations

      • Bordeaux, France, 33 000
        • University Hospital
      • Lille, France, 59037
        • University Hospital
      • Paris, France, 75015
        • University Hospital
      • Rouen, France, 76031
        • University Hospital
      • Toulouse, France, 31 059
        • University Hospital

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

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
usual procedure for sperm extraction
Other Names:
  • 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 of extraction is performed under the operating microscope
Other Names:
  • Microdissection surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eric Huyghe, MD, PhD, U H Toulouse

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.

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 (Actual)

April 26, 2017

Primary Completion (Actual)

January 15, 2021

Study Completion (Actual)

December 27, 2023

Study Registration Dates

First Submitted

May 13, 2016

First Submitted That Met QC Criteria

May 13, 2016

First Posted (Estimated)

May 16, 2016

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

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.

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