NCT02773498

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

April 26, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

3.7 years

First QC Date

May 13, 2016

Last Update Submit

January 2, 2024

Conditions

Azoospermia

Outcome Measures

Primary Outcomes (1)

  • 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

    time of surgery

Study Arms (2)

conventional TESE

ACTIVE COMPARATOR

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

micro TESE

EXPERIMENTAL

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

Interventions

conventional TESEPROCEDURE

usual procedure for sperm extraction

Also known as: conventional surgery
conventional TESE
Micro TESEPROCEDURE

procedure of extraction is performed under the operating microscope

Also known as: Microdissection surgery
micro TESE

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Hospital

Bordeaux, 33 000, France

Location

University Hospital

Lille, 59037, France

Location

University Hospital

Paris, 75015, France

Location

University Hospital

Rouen, 76031, France

Location

University Hospital

Toulouse, 31 059, France

Location

Related Publications (1)

  • 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.

    PMID: 12407050BACKGROUND

MeSH Terms

Conditions

Azoospermia

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Eric Huyghe, MD, PhD

    U H Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 16, 2016

Study Start

April 26, 2017

Primary Completion

January 15, 2021

Study Completion

December 27, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations

FR(5)