Objectives: To assess the Efficiency of trans-vaginal ultrasonography versus hysteroscopy in finding intrauterine pathologies in infertile women.
Design: a diagnostic clinical trial.
Setting and conduct: The eligible infertile women who will refer to Fatemieh Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) being infertile; (b) more than one year has passed from the infertility; (c) infertility due to the woman's somatic disorders
Exclusion criteria: having hormonal dysfunction in infertile woman.
Intervention group: Diagnostic trans-vaginal ultrasonography once on the first day and then hysteroscopy once on the second day.
Control group: Each patient will be examined with both diagnostic approaches, therefore, each patient will be compared with him/herself.
Primary outcome: Assessing the intrauterine pathologies.
Secondary outcome: Nothing.
Randomization: Not applicable because each patient will be compared with him/herself.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510049014N80
Registration date:2015-10-12, 1394/07/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-12, 1394/07/20
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2015-08-21, 1394/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficiency of trans-vaginal ultrasonography versus hysteroscopy in finding intrauterine pathologies in infertile women: a diagnostic clinical trial
Public title
Efficiency of trans-vaginal ultrasonography versus hysteroscopy in finding intrauterine pathologies in infertile women
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: (a) being infertile; (b) more than one year has passed from the infertility; (c) infertility due to the woman's somatic disorders
Exclusion criteria: having hormonal dysfunction in infertile woman.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Randomization: Not applicable because each patient will be compared with him/herself.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.UMSHA.REC.1394.138
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Assessing the intrauterine pathologies
Timepoint
On the first day of study
Method of measurement
ultrasonography and hysteroscopy
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Diagnostic trans-vaginal ultrasonography once on the first day and then hysteroscopy once on the second day
Category
Diagnosis
2
Description
Each patient will be examined with both diagnostic approaches, therefore, each patient will be compared with him/herself
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Firoozeh Zonoori
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
Fatemieh Hospital
Full name of responsible person
Dr Firoozeh Zonoori
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
zonoor2001@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Mahnaz yavangi
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
m_yavangui@ yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)