acupuncture effect on spermogram in patients with varicocele
Design
clinical trial with one interfering group.
Settings and conduct
32 male patients with grade 1 or 2 varicocele entering Ghaem or IMAM Reza hosspital will be evaluated. after inform consent, patients will be tested for spermogram and those with abnormal spermogram ( volume,sperm count, motility, forward movement and morphology) will be reffered to IMAM Reza hospital ,acupuncture deppartment for treatment. after completing treatment period spermogram will be tested again and its parameters will be compaired before and after treatment.
the study does not include any control group.
Participants/Inclusion and exclusion criteria
Male patients entering Ghaem and IMAM Reza hospital with grade 1 or 2 varicocele and abnormal spermogram parameters (volume,count,motility,forward movement, morphology).
patients use cigarettes before and after treatment,effect of cigarettes is not interfering our study but those whom start to use cigarettes while treatment will be excluded.
Patients with feveral infectious diseases will be tested for spermogram three month after healing..
Courage patients to eliminate body building or hormonal substance use/abuse as well as substances could possibly effect spermogram.
Not taking other treatments during study.
Intervention groups
patients undergo 10 sessions of acupuncture on genitalia .spermogram will be again tested 3 month after.
Main outcome variables
expected outcome is change in spermogram parameters after treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240309061229N1
Registration date:2024-04-07, 1403/01/19
Registration timing:registered_while_recruiting
Last update:2024-04-07, 1403/01/19
Update count:0
Registration date
2024-04-07, 1403/01/19
Registrant information
Name
yasser hosseinzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3878 0890
Email address
yasserhosseinzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-05-04, 1403/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
acupuncture effect on spermogram parameters in varicocele patients
Public title
acupuncture effect on spermogram parameters in varicocele patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
male gender
grade 1 or 2 varicocele confirmed by sonography assessment
Exclusion criteria:
Patients with cigarette use three month before spermogramm assessment.
patients with history of infection with fever causing diseases three month before spermogramm assessment.
patients with history of taking any hormonal drugs three month before spermogramm assessment.
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad Uniersity of Medical Scienc faculity of medicinee
Street address
Vakil abad BLV. azadi square.ferdowsi univercity campus
Patients entering Ghaem and Imam Reza hospital with abnormal spermogramm will go for full treatment course of acupuncture medicine (12 sessions each session 10 needles from Suzhou Huaniqiu Acupuncture Appliance) and will be undergo spermogramm test again after treatment.Spermogramm outcome will be compaired befor ad after treatment.This study has no control group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospial in Mashhad
Full name of responsible person
Yasser Hossenzadeh
Street address
Mashhad.Ahmad abad BLV
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0001
Fax
+98 51 3845 3239
Email
b.ghaem@mums.ac.ir
2
Recruitment center
Name of recruitment center
IMAM Reza hospital Mashhad
Full name of responsible person
Yasser Hosseinzadeh
Street address
Ebene Sina avenue. IMAM Reza square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafagodi
Street address
Vakil abad BLV. Azadi square. West door Ferdowsi University Campus
City
Mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Phone
+98 51 3878 0890
Email
yasserhosseinzadeh@gmail.com
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
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
Mashhad University of Medical Sciences
Full name of responsible person
Zhila Sheikhi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
No.41,Khaghani 24 ,Piroozi blvd,Rezashahr
City
Mashhad
Province
Razavi Khorasan
Postal code
9177850024
Phone
+98 51 3878 0890
Email
yasserhosseinzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zhila Sheikhi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
No.41,Khaghani 24 ave,Piroozi Blvd,Rezashahr
City
Mashhad
Province
Razavi Khorasan
Postal code
9177850024
Phone
+98 51 3878 0890
Email
yasserhosseinzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zhila Sheikhi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
No41,Khaghani 24,Piroozi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177250034
Phone
+98 51 3878 0890
Email
sheikizh@mums.ac.ir
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
in this study all of data's will be public.
When the data will become available and for how long
After publish of the study
To whom data/document is available
The persons who are working at a university position
Under which criteria data/document could be used
Research
From where data/document is obtainable
The Central library
What processes are involved for a request to access data/document