Clinical trial NCT02773498: Comparison of Medical Results of Testicular Sperm Extraction by Conventional Surgery and Microsurgical Track
Official title: Comparison of Medical Results of Testicular Sperm Extraction by Conventional Surgery and Microsurgical Track
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Azoospermia
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: sperm extraction
timeFrame: time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital
city: Lille
country: France
facility: University Hospital
city: Paris
country: France
facility: University Hospital
city: Rouen
country: France
facility: University Hospital
city: Toulouse
country: France
facility: University Hospital
Study officials:
affiliation: U H Toulouse
name: Eric Huyghe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.