Infertility is a common problem in gynecology. Hysterosalpingography (HSG) is one of the main diagnostic procedures that use for evaluation of uterine and fallopian tubes openness. While this procedure is a non invasive and don't need to anesthesia and cervical dilation, however patients have discomfort and lower abdominal pain during and after HSG. It is due to cervical manipulation, uterine distension and peritoneal sensitivity. Pain during this procedure has negative effect on patient's adaption with treatment and physicians trying to overcome to this undesirable situation. Hyoscine is one of drugs that its effect on pain and spasm of fallopian tubes has not studied. So, it is necessary that we perform the study that measures the effect of Hyoscine on pain and spasm during and after HSG in infertile women. Main objective of this study is identification of hyoscine effect on pain and spasm during and after HSG in infertile women.
Patients will allocate in intervention and control groups. In the intervention group, 15 minute before the procedure, Ampoule hyoscine 20mg/cc will inject intramuscularly. In control group, Patient will receive 1cc placebo (distilled water) intramuscularly before the procedure. After injection of dye, patients recorded their severity of pain in the numeric analog scale. Then HSG will done and after the review will determine whether or not another graphy should be prepared. Presence or absence of fallopian tube spasm at this stage will be determined. If contrast does not pass through the fallopian tube after first and second injection, spasm will determined. Thirty minutes after completion of the procedure, the pain will be examined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021132455N2
Registration date:2017-06-26, 1396/04/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-26, 1396/04/05
Registrant information
Name
Mahboubeh Rezaei
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
rezaei_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2017-04-03, 1396/01/14
Expected recruitment end date
2017-09-05, 1396/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hyoscine on pain and fallopian tubes spasm during and after hysterosalpingography in infertile women
Public title
ٍEffect of hyoscine on pain and spasm during uterine graphy
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria: duration of HSG more than 45 min; unstable hemodynamic sings during HSG.
Negative inclusion criteria: contraindication of hyoscine use; uterine malignancy; vaginal bleeding; history of cervical surgery; pelvic inflammatory disease; use of any analgesic drugs before HSG; fallopian tube obstruction
Inclusion criteria: infertile women; age between 20 - 45 years; Having informed consent; performing the procedure (HSG) by a resident
Age
From 75 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of medical Sciences
Street address
Vice chancellor for research, 3th floor, Emam Mousa Kazem building, University complex, Basij Sq, Arak, Iran
City
Arak
Postal code
Approval date
2016-04-25, 1395/02/06
Ethics committee reference number
IR.ARAKMU.REC.1395.37
Health conditions studied
1
Description of health condition studied
Pain and Spasm in Fallopian tubes
ICD-10 code
N83.9
ICD-10 code description
Noninflammatory disorder of ovary, fallopian tube and broad ligament, unspecified
Primary outcomes
1
Description
Pain
Timepoint
During and after hysterosalpingography
Method of measurement
Numeric rating scale
2
Description
Spasm
Timepoint
During and after hysterosalpingography
Method of measurement
Graphy
Secondary outcomes
empty
Intervention groups
1
Description
In this study, after determination of sample size, patient will allocate in two groups: intervention and control groups according to table of random numbers. All of participants must be in their follicular phase of menstruation cycle. This study is double blind and two groups of patients and researcher will not know about the hyoscine or placebo groups.
Category
Treatment - Drugs
2
Description
In the intervention group, 15 minute before the procedure, hyoscine 20 mg/cc will inject intramuscularly
Category
Treatment - Drugs
3
Description
In control group, Patient will receive 1cc placebo (distilled water) intramuscularly
Category
Treatment - Drugs
4
Description
After injection of dye, patients recorded their severity of pain in the numeric analog scale. Then HSG will done and after the review will determine whether or not another graphy should be prepared. Presence or absence of fallopian tube spasm at this stage will be determined. If contrast does not pass through the fallopian tube after first and second injection, spasm will determined. Thirty minutes after completion of the procedure, the pain will be examined.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiology department, Valieasr hospital, Arak University of Medical Sciences, Arak, Iran
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak university of Medical Sciences
Full name of responsible person
Vice Chancellor for Research Office
Street address
Vice chancellor for research, 3th floor, Emam Mousa Kazem building, University complex, Basij Sq, Arak, Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak university of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Marzieh Rezaei
Position
General physician, Radiology َAssistant
Other areas of specialty/work
Street address
Radiology department, Valiasr hospital, Arak, Markazi province, Iran
City
Arak
Postal code
Phone
+98 86 3328 9930
Fax
Email
m4.rezaei@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
َArak university of Medical Sciences
Full name of responsible person
Marzieh Rezaei
Position
General physician, Radiology َAssistant
Other areas of specialty/work
Street address
Radiology department, Valiasr hospital, Arak, Markazi province, Iran
City
Arak
Postal code
Phone
+98 86 3328 9930
Fax
Email
m4.rezaei@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Marzieh Rezaei
Position
General physician, Radiology َAssistant
Other areas of specialty/work
Street address
Radiology department, Valiasr hospital, Arak, Markazi province, Iran
City
Arak
Postal code
Phone
+98 86 3328 9930
Fax
Email
m4.rezaei@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)