The aim of this study is evaluation of the effect of evening primrose on dilatation of cervix and pain during and after hysterosalpangiography. This study is a double blind clinical trial. This study is double blind because researcher and patients don't aware from this grouping. In this study 66 patients who are candidate for hysterosalpangiography participate in the study. We will divide patients into two groups randomly through random number table. We prescribe evening primrose produced by Barij, 1000 milligram oral tab, BD, from three days before hysterosalpangiography to start of process in intervention group. We prescribe placebo 1000 milligram oral tab, BD, from three days before hysterosalpangiography in control group. We record pain during and after hysterosalpangiography and 4 hours after hysterosalpangiography. We record fallopian tube spasm during hysterosalpangiography. Inclusion criteria: infertility; being at the age of 20 to 40 years; female; candidate for hysterosalpangiography; hysterosalpingography performing by one researcher resident in training. Exclusion criteria: Severe dysmenorrhea; Pelvic infection; history of cervical stenosis; Sensitization to the drug; hysterosalpingography duration more than 45 minutes; Unstable hydrodynamic symptoms during hysterosalpingography; Vaginal delivery; Secondary infertility.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070520258N52
Registration date:2017-09-12, 1396/06/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-12, 1396/06/21
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor and Research,Arak University of Medical Sciences
Expected recruitment start date
2017-05-31, 1396/03/10
Expected recruitment end date
2019-03-12, 1397/12/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of evening primrose on cervix dilatation and pain during and after hysterosalpangiography in infertile women
Public title
Effect of evening primrose on pain during hysterosalpangiography in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:infertility; 20 to 40 years; female; candidate for hysterosalpangiography; hysterosalpingography should be done just by one researcher resident.
Exclusion criteria: Severe dysmenorrhea; Pelvic infection; history of cervical stenosis; Sensitization to intervention drug; duration of hysterosalpingography greater than 45 minutes; Unstable hydrodynamic symptoms during hysterosalpingography; Vaginal delivery; Secondary infertility
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomize by random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.ARAKMU.REC.1396.42
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
pain
Timepoint
during and after hysterosalpangiography and 4 hours after hysterosalpangiography
Method of measurement
Visual Analogue Scale
2
Description
Tube spasm
Timepoint
During hysterosalpangiography
Method of measurement
observation by hysterosalpangiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We prescribe evening primrose produced by Barij, 1000 milligram oral tab, BD, from three days before hysterosalpangiography to start of process in intervention group.
Category
Treatment - Drugs
2
Description
Control group: We prescribe placebo 1000 milligram oral tab, BD, from three days before hysterosalpangiography in control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Private outpatient Radiology Clinic
Full name of responsible person
Dr Fatemeh Safi
Street address
Shariati squre,Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences