The effect of endometrial scratch versus no scratch on pregnancy outcome in patients undergoing intrauterine insemination: a single blind randomized clinical trial
Objectives: To assess the effect of endometrial scratch versus no scratch on pregnancy outcome in patients undergoing intrauterine insemination.
Design: A single blind randomized clinical trial.
Setting and conduct: The eligible patients undergoing intrauterine insemination who will refer to … Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 35 years; body mass index less than or equal to 30 and greater than or equal to 18; normal mensural period; normal fallopian tube.
Exclusion criteria: Hirsutism; autoimmune disease; endocrine disease; using cigarette of alcohol.
Intervention group: Endometrial scratch using Pipelle in the luteal phase and one week before intrauterine insemination.
Control group: Introducing cotton swab into the uterus without scratching in the luteal phase and one week before intrauterine insemination.
Primary outcome: Assessing pregnancy three months after intervention using sonography.
Randomization: Random assignment of the patients to the intervention and control groups using random number table.
Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201707129014N174
Registration date:2017-07-14, 1396/04/23
Registration timing:prospective
Last update:
Update count:1
Registration date
2017-07-14, 1396/04/23
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 and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of endometrial scratch versus no scratch on pregnancy outcome in patients undergoing intrauterine insemination: a single blind randomized clinical trial
Public title
The effect of endometrial scratch versus no scratch on pregnancy outcome in patients undergoing intrauterine insemination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 35 years; body mass index less than or equal to 30 and greater than or equal to 18; normal mensural period; normal fallopian tube.
Exclusion criteria: Hirsutism; autoimmune disease; endocrine disease; using cigarette of alcohol.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
284
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups using random number table.
Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
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
Approval date
2017-05-27, 1396/03/06
Ethics committee reference number
IR.UMSHA.REC.1396.153
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Assessing pregnancy
Timepoint
three months after intervention
Method of measurement
using sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Endometrial scratch using Pipelle in the luteal phase and one week before intrauterine insemination.
Category
Treatment - Surgery
2
Description
Control group: Introducing cotton swab into the uterus without scratching in the luteal phase and one week before intrauterine insemination.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Nesa Varmaghani
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and 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 and 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 Nesa Varmaghani
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
nvarmaghani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Nesa Varmaghani
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
nvarmaghani@gmail.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
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)