Protocol summary
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Study aim
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Influence of growth hormone supplementation on pregnancy outcome of frozen thawed embryo transfer cycle(FET)
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Design
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non randomized 2 arm parallel group with 50 patients
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Settings and conduct
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Endometrial preparation will be done from second day of cycle with 6mg daily estradiol in patient who are candidate for frozen thawed embryo transfer and serial sonography will be done from 12th day of cycle ;when thickness reaches 7mm or more and patients have including criteria they will divided into 2 groups ;in control group we just prescribe 400mg daily progesterone for 3 days and in case group they will receive 1.2 mg growth hormone along with 400mg progesterone.72 hours later all pateints will be transferred maximum 2 cleaved embryo; serum BHCG wil be checked 2weeks later and if it is positive, vaginal sonography must be done for identification of gestational sac with fetal heart beat.
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Participants/Inclusion and exclusion criteria
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including criteria:20-40 years old infertile patient who will transfered frozen thawed embryo and have adequate endometrial thickness
excluding criteria: uterus malformation or adhesion, sever andometriosis or adenomyosis and recurrent implantation failure
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Intervention groups
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20-40 years old infertile woman who are candidate for frozen thawed embryo transfer and have appropriate endometrium received 1.2 mg daily growth hormone along with progesterone
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Main outcome variables
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chemical pregnancy; clinical pregnancy
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:
IRCT20091018002604N5
Registration date:
2020-03-02, 1398/12/12
Registration timing:
retrospective
Last update:
2020-09-16, 1399/06/26
Update count:
1
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Registration date
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2020-03-02, 1398/12/12
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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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Expected recruitment start date
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2019-09-22, 1398/06/31
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Expected recruitment end date
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2020-02-03, 1398/11/14
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Actual recruitment start date
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2019-09-22, 1398/06/31
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Actual recruitment end date
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2020-02-03, 1398/11/14
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Trial completion date
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2020-03-04, 1398/12/14
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Scientific title
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Influence of growth hormone supplementation on pregnancy outcome of patients undergoing frozen thawed embryo transfer(FET)
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Public title
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Influence of adding growth hormone in frozen embryo transfer cycle outcome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
20-40 years old infertile patient candidate for frozen thawed embryo transfer
Exclusion criteria:
uterus malformation-sever endometriosis and adenomyosis-uterus adhesion-recurrent implantation failure
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Age
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From 20 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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3
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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:
100
Actual sample size reached:
100
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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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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2019-09-14, 1398/06/23
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Ethics committee reference number
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IR.SSU.RSI.REC.1398.025
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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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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chemical pregnancy
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Timepoint
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2weeks after embryo transfer
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Method of measurement
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serum BHCG
Secondary outcomes
1
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Description
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clinical pregnancy
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Timepoint
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2weeks after positive BHCG
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Method of measurement
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vaginal sonography
Intervention groups
1
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Description
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Intervention group:Endometrial preparation will be done for 20-40 years old infertile woman who are candidate for frozen thawed embryo transfer from second day of cycle with 6 mg daily estradiol and serial sonography will be done from 12th day of cycle ;when thickness reaches 7 mm ,they receive 1.2 mg daily growth hormone along with 400 mg progesterone for 3 days and then embryo transfer will be done.
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Category
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Treatment - Drugs
2
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Description
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Control group: :Endometrial preparation will be done for 20-40 years old infertile woman who are candidate for frozen thawed embryo transfer from second day of cycle with 6 mg daily estradiol and serial sonography will be done from 12th day of cycle ;when thickness reaches 7 mm ,they receive 400 mg progesterone for 3 days and then embryo transfer will be 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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Vice chancellor for research,Shahid Sadoughi University of Medical Science,Yazd,Iran
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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no more information exist
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available