Efficacy of Synbiotic (FamiLact) as an Adjuvant Therapy in Improvement of Semen Parameters of Patients Undergoing Varicocelectomy: A Randomized Double-Blinded Controlled Trial
Evaluation of semen parameters after varicocelectomy in probiotic group and placebo group
Design
This study is a phase 3 double-blind randomized clinical trial performed on 84 patients. Patients are randomly divided into two groups of 42 by random allocation software, which intervention group receives symbiotic and the placebo control group.
Settings and conduct
This study is performed in the Baqiyatallah Hospital of Tehran. Infertile patients are divided into two groups after the varicocelectomy and one group is taking synbiotics and the other group is taking a placebo. This is a two-sided blind study in which participants and outcome assessors are unaware of the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include all men with infertility who are candidates for unilateral varicocelectomy. exclusion criteria include cryptorchidism, epididymorchitis, genitourinary trauma, prostatitis, testicular torsion, history of inguinal or genital surgery, history of hormonal therapy, endocrinopathies, history or current use of cytotoxic drugs such as immunosuppressants and immunosuppressants, Recent sexually transmitted infections.
Intervention groups
In this study, the intervention group is given a symbiotic capsule and the control group is given a capsule similar to the intervention group without effective substance.
Main outcome variables
1- seminal fluid volume
2- sperm number
3-sperm concentration
4-sperm motility
5-sperm with normal morphology
6-pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150420021869N4
Registration date:2021-08-06, 1400/05/15
Registration timing:prospective
Last update:2021-08-06, 1400/05/15
Update count:0
Registration date
2021-08-06, 1400/05/15
Registrant information
Name
Farshad Gholipour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6636 2089
Email address
f-gholipour@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Synbiotic (FamiLact) as an Adjuvant Therapy in Improvement of Semen Parameters of Patients Undergoing Varicocelectomy: A Randomized Double-Blinded Controlled Trial
Public title
the effect of synbiotic on seminal fluid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men with infertility who are candidates for unilateral varicocelectomy
Exclusion criteria:
Cryptorchidism
Epididymitis and orchitis
urogenital trauma
prostatitis
testicular torsion
history of inguinal or genital surgery
history of hormone therapy
endocrinopathy
history or current use of cytotoxic drugs, anti epileptic agent and androgens
recent history of sexual transmitted disease
Age
From 18 years old to 40 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients are randomly assigned to control and intervention groups In individual units by random allocation software. In this way, the number of each patient is given to the software and the patient group (case or control) is specified.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blinded study in which participants and evaluators of the outcome are blind. In such a way the participant by random allocation software is randomly assigned to the case or control group. Then, if he is in the case group, he will receive the drug, and if he is in the control group, he will receive a completely similar placebo. The participants don't know that they are receiving medication or the placebo and the outcome assessors do not know the group of participants too and record their findings based on patient numbers
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Baqiyatallah Hospital
Street address
vanak square,mulla sadra street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2021-01-09, 1399/10/20
Ethics committee reference number
IR.BMSU.BAQ.REC.1399.049
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
seminal fluid volume
Timepoint
before varicocelectomy and 3 months after surgery
Method of measurement
seminal analysis
2
Description
sperm count
Timepoint
before varicocelectomy and 3 month after varicocelectomy
Method of measurement
seminal analysis
3
Description
sperm concentration
Timepoint
before varicocelectomy and 3 month after varicocelectomy
Method of measurement
seminal analysis
4
Description
progressive sperm motility
Timepoint
before varicocelectomy and 3 month after varicocelectomy
Method of measurement
seminal analysis
5
Description
sperm with normal morphology
Timepoint
before varicocelectomy and 3 month after varicocelectomy
Method of measurement
seminal analysis
6
Description
fertility
Timepoint
6month after varicocelectomy
Method of measurement
pregnancy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, patients receive one Familact capsule containing 500 mg of synbiotics made by Zist takhmir Pharmaceutical Company for 6 months.
Category
Treatment - Drugs
2
Description
Control group: In this group, patients receive one capsule per day similar to the intervention group without the effective substance for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Farshad Gholipour
Street address
Vanak square, Mollasadra street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0435
Email
gholipour@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gholam Hossein Alishiri
Street address
Vanak square, Mollasadra street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
gholipour@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Esfahan University of Medical Sciences
Full name of responsible person
Farshad Gholipour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
gholipour@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farshad Gholipour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
gholipour@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farshad Gholipour
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
gholipour@med.mui.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
Undecided - It is not yet known if there will be a plan to make this available
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