The aim of this study is the comparison of open biopsy (TESE: Testicular Sperm Extraction) and aspiration (TESA: Testicular Sperm Aspiration) in non obstructive azoospermia (NOA). 180 patients with non-obstructive Azospermia at Royan Infertility Center who were candidates for surgical diagnosis of existence of sperm were recruited. Techniques of TESE and TESA for uniformity of procedure were discussed by 4 surgeons of the group. Testis selection (right or left) and techniques (TESE or TESA) were determined randomly. In TESA, the testis was aspirated at three separated sites (upper, middle and lower pole), using 20 ml syringe and 18-gauge needle. In TESE testicular biopsy was taken from the same sites. The ability of sperm retrieval in both techniques was compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903114077N1
Registration date:2010-09-10, 1389/06/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-09-10, 1389/06/19
Registrant information
Name
Majid Vafaei
Name of organization / entity
Royan Institute/IslamicAzad University of Damghan,Iran-
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2000
Email address
m_vafaei@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Royan Institute
Expected recruitment start date
2009-09-15, 1388/06/24
Expected recruitment end date
2010-05-05, 1389/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of diagnostic TESE and TESA in non-obstructive azoospermic patients
Public title
The comparison of diagnostic open biopsy and needle biopsy in non-obstructive azoospermic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Non obstructive Azoospermia, No Previous biopsy
Exclusion Criteria: atrophic testis, FSH levels more than 4 times of normal range
Age
From 20 years old to 50 years old
Gender
Male
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Royan institute
Street address
Royan Institute, No12, Hafez St, Banihashem St, Resalat Ave, Tehran
City
Tehran
Postal code
iran
Approval date
2009-08-18, 1388/05/27
Ethics committee reference number
EC/88/1016
Health conditions studied
1
Description of health condition studied
male infertility-azoospermia
ICD-10 code
N46
ICD-10 code description
Azoospermia NOS
Primary outcomes
1
Description
Recovery of sperm
Timepoint
once after sampling
Method of measurement
To study biopsy under a light microscope with 400X magnification
Secondary outcomes
empty
Intervention groups
1
Description
Testicular sperm extraction (TESE) Control gurop: A 1.5-2 cm incision was made in the scrotal skin and continued through the tunica albuginea and with a little push somniferous tubule appeared. A testicular biopsy for TESE was taken from (upper, middle and lower pole)
Category
Treatment - Drugs
2
Description
TESA Intervention gurop: In this procedure, a 20 ml syringe with 18 gauge needle was used. At first, we inserted the needle into the upper section of testis and slowly pulled it out to cause negative pressure. For maintaining the negative pressure, we moved the needle in and out of the testis for several times, then pulled the needle out, slowly. This acted as suction and caused the testis tissue to enter into the syringe.Taking biopsies were performed in the upper, middle and lower sections of the testis same as control gurop.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Jalil Hosseini -MD
Street address
Royan Institute, No12, Hafez St, Banihasem St, Resalat Ave, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Dr Shahverdi
Street address
Royan Institute
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Royan Institute - Islamic Azad University of Damghan, Iran
Full name of responsible person
Majid Vafaei
Position
Developmental Biology (Msc), student
Other areas of specialty/work
Street address
Royan Institute, No12, Hafez St, banihashem St, Resalat Ave, Tehran
City
Tehran
Postal code
19395-4644
Phone
+98 21 2356 2000
Fax
+98 21 2230 6481
Email
magic_w2004@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan institute
Full name of responsible person
Seyed Jalil Hosseini
Position
Andrologyist, Associate Professor
Other areas of specialty/work
Street address
Royan Institute, No12, Hafez St, Banihashem St, Resalat Ave, Tehran
City
Tehran
Postal code
19395-4644
Phone
+98 21 2356 2000
Fax
+98 21 2230 6481
Email
jhosseinee@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Majid Vafaei
Position
Islamic Azad university of Damghan, Developmental Biology, (Msc) student
Other areas of specialty/work
Street address
Royan Institute, No12, Hafez St, Banihashem St, Resalat Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 2356 2000
Fax
+98 21 2230 6481
Email
magic_w2004@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)