Evaluation of the stabilizing effect of mast cells (with and without varicocelectomy) on sperm DNA fracture and spermogram in infertile men and its comparison with varicocelectomy alone
Design
A clinical trial with a control group, with parallel, randomized groups, will be performed on 255 patients. There is a control group and two intervention groups. Participants enter each group at random after informed consent, and the DNA Fragmentation Index (DFI) will be measured before and after three months and compared between the groups.
Settings and conduct
At Ghaem Hospital and Milad Infertility Center, eligible patients underwent two DNA Fragmentation index (DFI) tests before the course and three months after the start of treatment and were monitored, and the results were analyzed. The analyst will be unaware of the intervention and control groups. Due to the differences in different treatments (presence / absence of surgery), it is not possible to blind patients and physicians (evaluators).
Participants/Inclusion and exclusion criteria
Entry conditions: Men of childbearing age who complain of (male) infertility and have varicocele and informed consent.
Non-entry conditions: allergic reaction or drug complication, leukocytospermia, azoospermia, diabetics
Intervention groups
1. Those who undergo varicocelectomy microsurgery.
2. Those who are treated with 1 mg of oral ketotifen twice daily for three months.
3. Those who have undergone microsurgical varicocelectomy and are treated with 1 mg twice daily of ketotifen for three months.
Main outcome variables
DNA Fragmentation index (DFI) quantitatively in the form of chromosomal failure rate and spermogram quantitatively in the form of semen analysis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211217053436N1
Registration date:2022-01-27, 1400/11/07
Registration timing:retrospective
Last update:2022-01-27, 1400/11/07
Update count:0
Registration date
2022-01-27, 1400/11/07
Registrant information
Name
Alireza akhavan rezayat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3894 2203
Email address
sheikhzadehmm911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-29, 1399/06/08
Expected recruitment end date
2021-05-29, 1400/03/08
Actual recruitment start date
2020-08-29, 1399/06/08
Actual recruitment end date
2021-11-29, 1400/09/08
Trial completion date
2021-11-29, 1400/09/08
Scientific title
effect of varicocelectomy and/or mast cells stabilizer on sperm DNA fragmentation in infertile patients with varicocele
Public title
The effect of varicocelectomy and mast cell stabilizer on sperm DNA fragmentation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile men due to varicocele (in reproductive age)
Informed consent
Exclusion criteria:
Allergic reaction to drug
Drug complication
Leukocytospermia
Azoospermia
Diabetics
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
123
Actual sample size reached:
123
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using Excel software or dedicated randomization sites. Each group is assigned a code (for example, A, B, C). We write the codes in the order of the specified order on separate sheets. We put each sheet in a separate concealment envelope and close the lid. After referring each qualified patient and obtaining informed consent from him, an envelope is opened for the patient and according to the code written in it (A, B, C) the patient is placed in one of the three study groups.
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
Ethics committee of mashhad university of medical sciences
Street address
Qaem hospital, urology department, Ahmad Abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9178914833
Approval date
2021-01-26, 1399/11/07
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.689
Health conditions studied
1
Description of health condition studied
Infertility caused by varicocele
ICD-10 code
I86.1
ICD-10 code description
Scrotal varices
Primary outcomes
1
Description
Sperm DNA fragmentation
Timepoint
Before intervention and 3 months after intervention
Method of measurement
DNA Fragmentation Index percentage.
2
Description
Semen Analysis
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Semen Analysis
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In the control group, individuals undergo only varicocelectomy microsurgery and the outcome is evaluated after 3 months. (Surgery only)
Category
Treatment - Surgery
2
Description
First Intervention group: Those who are treated with 1 mg of oral ketotifen tablet (Which were usually the product of various domestic pharmaceutical companies and no specific brand was considered.) twice a day for three months. (Pharmaceutical only)
Category
Treatment - Drugs
3
Description
Second Intervention group: Those who have undergone varicocelectomy microsurgery and are still treated daily with 1 mg of ketotifen tablet (Which were usually the product of various domestic pharmaceutical companies and no specific brand was considered.) for three months. (Both surgery and medication)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Alireza Akhavan Aezayat
Street address
Ahmad Abad st.
City
Mashhad
Province
Razavi Khorasan
Postal code
9178914833
Phone
+98 51 3843 2256
Email
akhavanra@mums.ac.ir
2
Recruitment center
Name of recruitment center
Milad Infertility Research and Treatment Center
Full name of responsible person
Alireza Akhavan Rezayat
Street address
Akhond Khorasani 32 st.
City
Mashhad
Province
Razavi Khorasan
Postal code
9178914833
Phone
+98 51 3853 4021
Email
akhavanra@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Akhavan Rezayat
Street address
University Compound
City
Mashhad
Province
Razavi Khorasan
Postal code
9178914833
Phone
+98 51 3843 2256
Email
akhavanra@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Akhavan Rezayat
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Ahmad Abad st.
City
Mashhad
Province
Razavi Khorasan
Postal code
9178914833
Phone
+98 51 3843 2256
Email
akhavanra@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Akhavan Rezayat
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Ahmad Abad st.
City
Mashhad
Province
Razavi Khorasan
Postal code
9178914833
Phone
+98 51 3843 2256
Email
akhavanra@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Akhavan Rezayat
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Ahmad Abad st.
City
Mashhad
Province
Razavi Khorasan
Postal code
9178914833
Phone
+98 51 3843 2256
Email
akhavanra@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available