- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02773498
Comparison of Medical Results of Testicular Sperm Extraction by Conventional Surgery and Microsurgical Track (Microsperm)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eric Huyghe, MD, PhD
- Phone Number: 33561771028
- Email: huyghe.e@chu-toulouse.fr
Study Contact Backup
- Name: Thierry Almont
- Email: almont.t@chu-toulouse.fr
Study Locations
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Bordeaux, France, 33 000
- University Hospital
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Lille, France, 59037
- University Hospital
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Paris, France, 75015
- University Hospital
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Rouen, France, 76031
- University Hospital
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Toulouse, France, 31 059
- University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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usual procedure for sperm extraction
Other Names:
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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
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procedure of extraction is performed under the operating microscope
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sperm extraction
Time Frame: time of surgery
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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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time of surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eric Huyghe, MD, PhD, U H Toulouse
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/15/7840
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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