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Evaluation of the effect of new method of varicocele surgery (gobernectomy and) on fertility based on DNA fragmentation index

Protocol summary

Study aim
Identification of the causes leading to non-response to surgical treatment in patients suffering from varicocele and infertility and the invention of new techniques to improve surgical outcomes
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized , on 110 patients.Toss and coin was used for randomization.
Settings and conduct
Study is done on infertile people referred to the 501 hospital who have second and third degree varicocele and have impaired Deoxyribonucleic acid Fragmentation Index .The first group of patients undergo standard surgery without the help of a microscope , for patients of the second group, in addition to standard surgery, gubranaculum closure is performed
Participants/Inclusion and exclusion criteria
Inclusion criteria: infertility, second and third degree varicocele, having DFI impaired sperm fluid analysis test Exclusion criteria: normal fertility, history of undescended testis, history of testicular torsion, having first-degree varicocele, no DFI abnormality in the semen analysis
Intervention groups
The first group of patients undergo standard surgery without the help of a microscope , for patients of the second group, in addition to standard surgery, gobranaculum closure is performed
Main outcome variables
Evaluation of the effect of different varicocele surgery techniques on the improvement of Deoxyribonucleic acid Fragmentation Index and fertility

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200122046220N2
Registration date: 2021-04-04, 1400/01/15
Registration timing: registered_while_recruiting

Last update: 2021-04-04, 1400/01/15
Update count: 0
Registration date
2021-04-04, 1400/01/15
Registrant information
Name
arash karimi baba ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 8257
Email address
arashkarimi86@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of new method of varicocele surgery (gobernectomy and) on fertility based on DNA fragmentation index
Public title
Evaluation of varicocele surgery on deoxyribonucleic acid fragmentation index
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile people with second and third degree varicocele Impaired Deoxyribonucleic acid fragmentation index
Exclusion criteria:
History of orchitis or testicular cancer Azoospermia History of inguinal or scrotal surgery Systemic inflammatory disease History of testicular trauma,
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization method was used to create a random sequence.We considered the block size to be 4 so that in each block 2 patients were operated by conventional method and two patients by conventional method + gubernaculectomy.We entered information about the block size and sample size into the sealedenvelope.com website to specify the desired sequence in each block.In this way, 20 blocks of size 4 were identified to randomize the sample size of 80.With this method, we were able to Divide patients into two groups in a balanced and unpredictable way.Also to hide random allocation , custom codes created by the same website were used for each person entered into the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants do not know which surgical technique they undergo.Patients are not conscious during surgery.After surgery it is not possible for the patient to determine the type of technique due to the type of skin incision etc.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
Unit 2, No. 9 Omrani Alley, Golshan intersection, Azarbayjan Ave.
City
Tehran
Province
Tehran
Postal code
1315793518
Approval date
2021-01-06, 1399/10/17
Ethics committee reference number
IR.AJAUMS.REC.1399.201

Health conditions studied

1

Description of health condition studied
Infertility associated with varicocele and impaired DFI
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Percentage of fertility and DFI improvement after surgery
Timepoint
DFI measurement before and three months after surgery
Method of measurement
Percentage of sperm with defective chromosomes to total sperms

Secondary outcomes

empty

Intervention groups

1

Description
Control group: People over the age of 18 with varicocele and infertility who have impaired Deoxyribonucleic acid Fragmentation Index in semen analysis (DFI > 30%) undergoing varicocele surgery in a standard approach (Closing the spermatic vessels of the cord without the help of a microscope in the inguinal canal)
Category
Treatment - Surgery

2

Description
Intervention group: People over the age of 18 with varicocele and infertility who have impaired Deoxyribonucleic acid Fragmentation Index (DFI > 30%) in semen analysis undergoing varicocele surgery in a standard way plus gubernaculectomy
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Aja Hospital 501
Full name of responsible person
Arash Karimi Baba Ahmadi
Street address
Unit 2, No. 9 Omrani Alley, Golshan intersection, Azarbayjan Ave.
City
Tehran
Province
Tehran
Postal code
1318834651
Phone
+98 21 6693 8257
Email
arashkarimi86@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Arash Karimi Baba Ahmadi
Street address
Unit 2, No. 9 Omrani Alley, Golshan intersection, Azarbayjan Ave.
City
Tehran
Province
Tehran
Postal code
1318834651
Phone
+98 21 6693 8257
Email
arashkarimi86@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Arash Karimi Baba Ahmadi
Position
Non-Academic Specialist Physician
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
No. 9, Omranipour Alley , Golshan st., Azarbayjan Ave.
City
Tehran
Province
Tehran
Postal code
1318834651
Phone
+98 21 6693 8257
Email
arashkarimi86@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Arash Karimi
Position
Non-Academic Specialist Physician
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
No. 9, Omranipour Alley , Golshan st., Azarbayjan Ave.
City
Tehran
Province
Tehran
Postal code
1318834651
Phone
+98 21 6693 8257
Email
arashkarimi86@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Arash Karimi
Position
Non-Academic Specialist Physician
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
No. 9, Omranipour Alley , Golshan st., Azarbayjan Ave.
City
Tehran
Province
Tehran
Postal code
1318834651
Phone
+98 21 6693 8257
Email
arashkarimi86@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no restrictions
From where data/document is obtainable
Arash Karimi arashkarimi1510@yahoo.com
What processes are involved for a request to access data/document
Access to data is done by sending an e-mail to the previous address
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