Comparison of the effect of the various anesthesia following testicular sperm extraction (TESE) on sperm parameters in men with azoospermia undergoing ICSI
The aim of this study is to evaluate the efficacy the various anesthesia in extraction a sufficient quality of sperm for men with Azoospermia undergoing ICSI. A single blind randomized clinical trial is done on Azoospermic men with very low sperm production within the testis in Infertility and Reproductive Health Research Center located in Babol (North of Iran). 100 Azoospermic men according inclusion criteria (age 20-50 years with Azoospermic …) and exclusion criteria (men with a history of particular medicine to induce or suppress spermatogenesis…) randomly assign to two groups. In one group (control) using general anesthesia and the other group using (case) local anesthesia is done testicular sperm extraction. The concentration, motility and morphology of the spermatozoa present in each sample are evaluate immediately after processing, as well as 1 and 2 hours following processing. The values compared each other within and between both groups. First outcome is to improve of sperm parameters and second outcome is the side effect of drugs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505071760N39
Registration date:2015-05-16, 1394/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-16, 1394/02/26
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of the various anesthesia following testicular sperm extraction (TESE) on sperm parameters in men with azoospermia undergoing ICSI
Public title
Comparison of the effect of the various anesthesia following testicular sperm extraction (TESE) on sperm parameters in men with azoospermia undergoing ICSI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-50 years; Azoospermic men; Body mass index between 19 and 28;
Exclusion criteria:
Men with a history of particular medicine to induce or suppress Spermatogenesis; High temperature; Radiotherapy; Lower abdomen surgery; Smoking; Alcohol; Failure to hypogonadism in the last three months
Age
From 20 years old to 50 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a test done by the blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical sciences
Street address
Babol University of Medical Sciences, Ganjafroz Avenu
City
Babol
Postal code
Approval date
2011-07-23, 1390/05/01
Ethics committee reference number
4268
Health conditions studied
1
Description of health condition studied
Azoospermia
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Improve sperm
Timepoint
One hour, two hour after testicular sperm extraction (TESE)
Method of measurement
Laboratory
Secondary outcomes
1
Description
Side effects of drugs
Timepoint
During drug use
Method of measurement
Clinical
Intervention groups
1
Description
Intervention Groups:
Local anesthesia with Lidocaine (10 cc 2% plain Lidocaine (Sina Daru Ltd, Iran)
Category
Treatment - Drugs
2
Description
Controls Groups:
General anesthesia
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh-Zahra Fertility & infertility Medical Center
Full name of responsible person
Masoomeh Golsorkgtabar Amiri
Street address
Fatemeh-Zahra Medical Center-Fatemeh-zahra Infertility & Reproductive Health ResearchCenter , Amol, Babol, Old Road, After Mohammad Hassan Khan Bridg
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
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
Fatemehzahra Infertility & Reproductive Health Research Center
Full name of responsible person
Dr. Molood Aghajani Delavar
Position
PhD in Women's Health
Other areas of specialty/work
Street address
Fatemehzahra Infertility & Reproductive Health Research Center, After Mohammad Hassan Khan Bridge, old Road Amol
City
Babol
Postal code
Phone
+98 11 3227 4881
Fax
Email
moloodaghajani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemehzahra Infertility & Reproductive Health Research Center
Full name of responsible person
Dr. Hamid Shafi
Position
Urologist
Other areas of specialty/work
Street address
Fatemehzahra Infertility & Reproductive Health Research Center, After Mohammad Hassan Khan Bridge, old Road Amol
City
Babol
Postal code
Phone
+98 11 3227 4881
Fax
Email
Hamid_Shafi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nargess Gholizadeh Pasha
Position
MSc
Other areas of specialty/work
Street address
Babol University of Medical sciences, Ganjafroz Avenue
City
Babol
Postal code
Phone
00
Fax
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)