The purpose of this study was to evaluate the efficacy of varicocelectomy on improving ARTs (assisted reproductive techniques) indications on the base of Kruger strict morphology test.
Method and materials: For assessing of improving ART levels after varicocelectomy in a randomized and case –control study we compared the results of sperm analysis parameters between 67 infertile operated patients with 71 matched no operated groups in one-year duration.
All subjects included in this study (both study and control groups) had clinical varicoceles and were infertile, we excluded varicocele re-operated, with known infertility risk factors, singles, fertile or fertility history men, and wives older than 35-year-olds.
Intervention: sub- Inguinal varicocelectomy with magnification in the study group.
The primary outcome in this study was spermogram parameters (count, motility, and sperm morphology on Kruger standards) after the intervention, and their wife pregnancy was the secondary outcome at the end of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611091981N7
Registration date:2017-05-06, 1396/02/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-06, 1396/02/16
Registrant information
Name
Ali Asghar Ketabchi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 4348
Email address
a_ketabchi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Physiology Research Center, Kerman University of Medical Sciences
Expected recruitment start date
2010-12-31, 1389/10/10
Expected recruitment end date
2013-12-31, 1392/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of varicocelectomy on ARTs indications on base of Kruger strict morphology test
Public title
varicocelectomy and ARTs indications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: male gender; married; being infertile; clinical dignosis for varicocele. Exclusion criteria: single; fertile; known other infertility factors.
Age
From 22 years old to 28 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
255
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences
City
Kerman
Postal code
Approval date
2017-04-23, 1396/02/03
Ethics committee reference number
IR.KMU.REC.1396.03
Health conditions studied
1
Description of health condition studied
Male infertility
ICD-10 code
I86.1
ICD-10 code description
Scrotal varices
Primary outcomes
1
Description
spermogram
Timepoint
spermogram improvment
Method of measurement
spermanalysis kruger test
Secondary outcomes
1
Description
wife pregnancy
Timepoint
12 months
Method of measurement
sonograhy
Intervention groups
1
Description
watch full in control group with recommendations for avoiding known infertility risk factors
Category
Behavior
2
Description
sub inguinal varicocelectomy by magnification in intervention group with recommendations for avoiding known infertility risk factors
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
urology department, Bahonar Hospital, Kerman
Full name of responsible person
Street address
City
kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Hamid Najafi
Street address
Physiology Research Center, Kerman University of Medical Sciences
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Dr. Ali Asghar Ketabchi
Position
Urologist
Other areas of specialty/work
Street address
Urology Department, Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 3211 4348
Fax
Email
dr.ketabchi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Ali Asghar Ketabchi
Position
Urology Associate Professor
Other areas of specialty/work
Street address
Urology Department, Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 3211 4348
Fax
Email
dr.ketabchi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Ali Asghar Ketabchi
Position
Urology Associate Professor
Other areas of specialty/work
Street address
Urology Department, Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 3211 4348
Fax
Email
dr.ketabchi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)