Clinical trial NCT00484081: Microdissection Testicular Sperm Extraction (MicroTESE) and IVF-ICSI Outcome in Non-Obstructive Azoospermia (NOA)
Official title: Prospective Evaluation of Microdissection Testicular Sperm Extraction in Non-Obstructive Azoospermic Men and Their IVF-ICSI Related Outcomes at ART Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Azoospermia
Infertility
Keywords: TESE
NON-OBSTRUCTIVE
MICRODISSECTION
AZOOSPERMIA
ICSI
Lead sponsor: Clinic and Research Center in Human Reproduction Roger Abdelmassih
Sponsor class: OTHER
First posted: 2007-06-08
Enrollment: 53
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We evaluated the application of surgical testicular exploration with the aid of a microscope (MictoTESE) to increase the chances of obtaining sperm in men with impaired sperm production, a condition known as non-obstructive azoospermia.

We also evaluated the outcomes of these couples when the sperm obtained were used in ICSI (Intracytoplasmic Sperm Injection) during assisted reproductive technology treatment.

We believe that excellent results may be obtained with the use of the following techniques in the treatment of couples where non-obstructive azoospermia is a significant cause.

Detailed description: Men diagnosed with non-obstructive azoospermia and seeking assisted reproductive technology treatment (ART) are candidates for surgical sperm retrieval with the aid of microdissection. We believe that this approach may currently be the best option for these subjects.

We evaluated our surgical sperm retrieval rate associated to their serum LH, FSH, TOTAL TESTOTERONE and PROLACTIN levels, pre-operative testicular volume and also compared to the post-operative histological analysis of fixed testicular tissue specimens collected during the procedure, stained with haematoxylin and eosin.

We also evaluated the outcomes using ICSI based ART for these couples observing mean ICSI and fertilized oocytes, number and quality of embryos transferred, implantation and pregnancy rates.

Eligibility criteria: Inclusion Criteria:

* Men undergoing ART treatment with clinical diagnosis of non-obstructive azoospermia.
* Female partner undergoing ICSI based ART treatment

Exclusion Criteria:

* Men where non-obstructive azoospermia was not confirmed based on histological analysis of fixed testicular tissue specimens collected by open surgical testicular biopsy and stained with haematoxylin and eosin.

Primary outcomes:
measure: Sperm retrieval rate,mean male and female partner age,mean ICSI and fertilized oocytes, implantation, pregnancy and miscarriage rates.Testicular histology was also compared.
timeFrame: 17 months
Secondary outcomes:
measure: Sperm retrieval associated to pre-operative serum FSH, LH, Total Testosterone,Prolactin, testicular volume and post-operative testicular histology. ICSI and pregnancy results associated to sperm motility.
timeFrame: 17 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Clinic and Research Center in Human Reproduction Roger Abdelmassih
state: SP
Study officials:
affiliation: Clinic and Research Center in Human Reproduction Roger Abdelmassih
name: Pedro Ravizzini, Dr.
role: PRINCIPAL_INVESTIGATOR
References: