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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02773498
Acronym
Microsperm
Enrollment
50
Registered
2016-05-16
Start date
2017-04-26
Completion date
2023-12-27
Last updated
2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Azoospermia

Brief summary

To compare mobile 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.

Interventions

usual procedure for sperm extraction

PROCEDUREMicro TESE

procedure of extraction is performed under the operating microscope

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026