Protocol summary
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Study aim
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Whether endometrial injury in luteal phase prior to FET cycle would improve pregnancy outcomes
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Design
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Women who were candidate for FET were randomly divided into two groups of either endometrial injury before embryo transfer or no endometrial injury embryo transfer. In this not-blinded, phase 2 clinical trial with control group, randomization was performed using random number table.
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Settings and conduct
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100 women who were candidate for FET at Yazd Research and Clinical Center for Infertility were divided randomly without blindness into two groups of either endometrial injury before embryo transfer or no endometrial injury embryo transfer.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria include: women indicated for FET treatment, had one or more frozen embryo(s) and had a normal uterine cavity (confirmed by vaginal ultrasonography). The exclusion criteria were women <40 yrs, history of endocrine disorders (hypothyroidism, diabetes mellitus), intrauterine abnormality (uterine polyp, sub-mucosal fibroma, intrauterine adhesion) and severe endometriosis diagnosed by laparoscopy or endometrioma in ultrasound scanning.
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Intervention groups
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Intervention group: endometrial injury before embryo transfer
Control group: No endometrial injury before embryo transfer
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Main outcome variables
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Chemical pregnancy
General information
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Reason for update
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Updating the trial according to the last changes in inclusion and exclusion criteria, actual number of cases, date of recruitment and trial completion
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015101324512N1
Registration date:
2015-11-13, 1394/08/22
Registration timing:
retrospective
Last update:
2022-01-12, 1400/10/22
Update count:
2
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Registration date
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2015-11-13, 1394/08/22
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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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Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
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Expected recruitment start date
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2015-03-01, 1393/12/10
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Expected recruitment end date
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2015-06-30, 1394/04/09
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Actual recruitment start date
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2015-03-01, 1393/12/10
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Actual recruitment end date
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2015-06-30, 1394/04/09
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Trial completion date
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2015-12-29, 1394/10/08
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Scientific title
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The effect of endometrial injury on pregnancy rate in frozen- thawed embryo transfer
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Public title
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The effect of endometrial injury on pregnancy rate in frozen- thawed embryo transfer
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Infertile patients candidate for frozen- thawed embryo transfer who had one or more frozen embryo(s)
Women with a normal uterine cavity (confirmed by vaginal ultrasonography).
Exclusion criteria:
Women >40 yrs
History of endocrine disorders (hypothyroidism, diabetes mellitus)
Intrauterine abnormality (uterine polyp, sub-mucosal fibroma, intrauterine adhesion)
Severe endometriosis diagnosed by laparoscopy or endometrioma in ultrasound scanning.
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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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No information
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Sample size
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Target sample size:
120
Actual sample size reached:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this trial, 100 infertile women who were candidate for frozen embryo transfer were informed about the research design and signed a written consent form. All women were randomly divided into two groups. Randomization was simple, individual using a random number table.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2015-02-10, 1393/11/21
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Ethics committee reference number
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445
Health conditions studied
1
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Description of health condition studied
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Infertility
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ICD-10 code
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N98.9
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ICD-10 code description
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Complication associated with artificial fertilization, unspecified
Primary outcomes
1
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Description
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Chemicall pregnancy
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Timepoint
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14 days after transfer
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Method of measurement
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B-HCG test
Secondary outcomes
1
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Description
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Clinical pregnancy
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Timepoint
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3 weeks after positive B-HCG
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Method of measurement
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vaginal ultrasonography
Intervention groups
1
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Description
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In intervention group (50 patients)in cycle 21-23 days (before embryo transfer cycle) ,the edometrium is scratched with piple .
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Category
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Treatment - Drugs
2
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Description
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No intervention in control group is done.
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Category
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Treatment - Drugs
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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Deputy of Research and technology, Yazd Shahid Sadoughi 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All participant data sets are to be shared
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When the data will become available and for how long
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2 months after the result publication
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To whom data/document is available
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A journal in which the results are published
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Under which criteria data/document could be used
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Submission of an official application via the agent that is legally in charge
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From where data/document is obtainable
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Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran.
983538247085
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What processes are involved for a request to access data/document
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Submission of an official application via the agent that is legally in charge
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Comments
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