search
Back to results

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

Primary Purpose

Azoospermia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
conventional TESE
Micro TESE
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Azoospermia

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital
  • University Hospital
  • University Hospital
  • University Hospital
  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional TESE

micro TESE

Arm Description

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.

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

Outcomes

Primary Outcome Measures

sperm extraction
positivity (presence, coded 1) or negativity (absence, coded 0) of the sperm extraction, based on possibility of having at least 1 mobile sperm

Secondary Outcome Measures

Full Information

First Posted
May 13, 2016
Last Updated
August 22, 2023
Sponsor
University Hospital, Toulouse
search

1. Study Identification

Unique Protocol Identification Number
NCT02773498
Brief Title
Comparison of Medical Results of Testicular Sperm Extraction by Conventional Surgery and Microsurgical Track
Acronym
Microsperm
Official Title
Comparison of Medical Results of Testicular Sperm Extraction by Conventional Surgery and Microsurgical Track
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2017 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Azoospermia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional TESE
Arm Type
Active Comparator
Arm Description
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.
Arm Title
micro TESE
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
conventional TESE
Other Intervention Name(s)
conventional surgery
Intervention Description
usual procedure for sperm extraction
Intervention Type
Procedure
Intervention Name(s)
Micro TESE
Other Intervention Name(s)
Microdissection surgery
Intervention Description
procedure of extraction is performed under the operating microscope
Primary Outcome Measure Information:
Title
sperm extraction
Description
positivity (presence, coded 1) or negativity (absence, coded 0) of the sperm extraction, based on possibility of having at least 1 mobile sperm
Time Frame
time of surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Huyghe, MD, PhD
Phone
33561771028
Email
huyghe.e@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Thierry Almont
Email
almont.t@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Huyghe, MD, PhD
Organizational Affiliation
U H Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Bordeaux
ZIP/Postal Code
33 000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludovic Ferretti, MD
Email
ludovic.ferretti@gmail.com
Facility Name
University Hospital
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Active, not recruiting
Facility Name
University Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Thiuonn, MD
Email
nicolas.thiounn@aphp.fr
Facility Name
University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis Sibert, MD, PHD
Email
louis.sibert@chu-rouen.fr
Facility Name
University Hospital
City
Toulouse
ZIP/Postal Code
31 059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Huyghe, MD, PhD
Email
huyghe.e@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Thierry Almont
Email
almont.t@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
12407050
Citation
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. doi: 10.1093/humrep/17.11.2924.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs