Protocol summary
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Study aim
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To assess the effect of endometrial scratch versus no scratch on pregnancy outcome in patients undergoing intrauterine insemination.
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Design
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This is a single-blind randomized clinical trial, phase II, in which 300 eligible infertile women will be randomly assigned to the intervention and control groups
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Settings and conduct
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The eligible patients undergoing intrauterine insemination who will refer to … Hospital during the study period will be enrolled into the trial.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria
Age of 18 to 40 years
Infertility
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
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Intervention groups
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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
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Main outcome variables
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Primary outcome: Assessing pregnancy three months after intervention using sonography.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201707129014N174
Registration date:
2017-07-14, 1396/04/23
Registration timing:
prospective
Last update:
2018-02-12, 1396/11/23
Update count:
1
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Registration date
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2017-07-14, 1396/04/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
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Expected recruitment start date
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2017-12-22, 1396/10/01
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Expected recruitment end date
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2018-12-22, 1397/10/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of endometrial scratch versus no scratch on pregnancy outcome in patients undergoing intrauterine insemination: a single blind randomized clinical trial
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Public title
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The effect of endometrial scratch versus no scratch on pregnancy outcome in patients undergoing intrauterine insemination
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of 18 to 40years
Infertility
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
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
300
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization: Random assignment of the patients to the intervention and control groups using random number table.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-05-27, 1396/03/06
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Ethics committee reference number
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IR.UMSHA.REC.1396.153
Health conditions studied
1
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Description of health condition studied
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Female infertility
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ICD-10 code
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N97
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ICD-10 code description
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Female infertility
Primary outcomes
1
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Description
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Assessing pregnancy
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Timepoint
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three months after intervention
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Method of measurement
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using sonography
Intervention groups
1
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Description
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Intervention group: Endometrial scratch using Pipelle in the luteal phase and one week before intrauterine insemination.
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Category
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Treatment - Surgery
2
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Description
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Control group: Introducing cotton swab into the uterus without scratching in the luteal phase and one week before intrauterine insemination.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available