Protocol summary
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Study aim
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This study was conducted to
investigate the effects of GnRH agonist
administration on the implantation rate in
the FET cycles of women with RIF, prior to
estrogen-progesterone preparation of the
endometrium.
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Design
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The case group (n = 34) received 0.1 mg/day of the GnRH agonist (Variopeptyl, VarianDarou, Iran), subcutaneous, from day 21 of the cycle preceding the actual FET cycle. On the second day of the cycle, the dose of GnRH agonist was reduced to 0.05 mg and 6 mg/day oral estradiol valerate (2 mg, Aburaihan Co., Tehran, Iran) was also started. When the endometrial thickness reached to 7.5 mm, vaginal supplementation of Cyclogest® pessaries (Cox Pharmaceuticals, Barnstaple, UK) at 400 mg twice daily was started and the GnRH agonist was also stopped.
The control group (n = 33), received 6 mg/day oral estradiol valerate (2 mg, Aburaihan Co., Tehran, Iran) from the second day of the cycle without the GnRH agonist. In the two groups, frozen-thawed embryos were transferred on the fourth day of progesterone treatment.
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Settings and conduct
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In this randomized clinical trial, 67 infertile women with history of idiopathic RIF (at least two implantation failures), undergoing FET cycles in Yazd Reproductive Sciences Institute.
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Participants/Inclusion and exclusion criteria
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67 infertile women with history of idiopathic RIF (at
least two implantation failures), undergoing FETcycles included.
All women with endometrial polyp, uterine myoma, and
uterine anomaly were excluded from the study
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Intervention groups
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67 infertile women with history of idiopathic RIF (at
least two implantation failures), undergoing FETcycles included.
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Main outcome variables
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The clinical outcomes) including chemical and clinical pregnancy, in addition to implantation rates, were compared between the two groups.
General information
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Reason for update
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Update clinical trial based on the latest changes in method and recruitment and trial completion dates
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201708292604N3
Registration date:
2017-09-18, 1396/06/27
Registration timing:
registered_while_recruiting
Last update:
2021-04-19, 1400/01/30
Update count:
1
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Registration date
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2017-09-18, 1396/06/27
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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 of Shahid Sadoughi Universit,y of Medical Sciences, Yazd,Iran
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Expected recruitment start date
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2017-08-16, 1396/05/25
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Expected recruitment end date
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2017-11-16, 1396/08/25
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Actual recruitment start date
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2017-08-01, 1396/05/10
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Actual recruitment end date
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2017-11-30, 1396/09/09
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Trial completion date
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2018-01-30, 1396/11/10
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Scientific title
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Effect of GnRH-a in endometrial preparation for frozen-thawed embryo transfer cycles in patient with repeated implantation failure.
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Public title
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ٍٍEffect of GnRH-a in endometrial preparation for frozen-thawed embryo transfer cycles in patient with repeated implantation failure.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
infertile women with at least 2 previous failed implantation.
Exclusion criteria:
Endometrial polyp
myoma
uterine anomaly
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Age
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From 18 years old to 42 years old
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Gender
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Female
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Phase
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2-3
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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:
67
Actual sample size reached:
67
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients are divided into two groups of 34 patients according to permutation block method of control and intervention. Therapeutic tasks within the blocks are determined in such a way that they are random, but the desired allocation ratio is achieved in each block.
There are 8 blocks in each,is 8 numbers in order to reaches sample size to 64 and one block of 4 is considered. Generate random codes using random block allocation method which will be generated with the help of Random allocation software version 1. The first person eligible to enter the study is given number one and so on until the last person eligible for number 67 is given.Using a table generated by random allocation software by number, individuals are placed in the control and intervention group.
The output of Random allocation software version 1 is specified as A and B in the specified blocks, which describe the number of blocks and the number of patients in each block.
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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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2017-05-21, 1396/02/31
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Ethics committee reference number
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IR.SSU.RSI.REC.1396.1
Health conditions studied
1
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Description of health condition studied
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repeated implantation failure
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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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chemical pregnancy
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Timepoint
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2 weeks after embryo transfer
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Method of measurement
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serum BHCG
2
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Description
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clinical pregnancy
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Timepoint
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2 wk after positive β hCG
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Method of measurement
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the detection of a fetal heartbeat in sonography
3
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Description
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Implantation rate
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Timepoint
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2 wk after positive β hCG
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Method of measurement
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the number of gestational sacs per embryos transferred
Intervention groups
1
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Description
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In case group , patients receive daily subcutaneous injections of 0.1 mg of GnRH-a( diphereline) starting from day 21 of previous cycles.The dose is reduce to 0.05 mg from the second day of cycle when daily oral estradiol valerate 6mg is also started.Daily vaginal progesterone 400mg twice daily is started when endometrial thickness is > 7.5 mm and GnRH_a is also stopped.
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Category
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Treatment - Drugs
2
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Description
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In control group oral estradiol 6mg daily is started from day 2 cycle without diphereline. Daily vaginal progesterone 400mg twice daily is started when endometrial thickness is > 7.5 mm
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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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Yazd Reproductive Sciences Institute, Shahid Sadoughi University
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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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participant data set able to be shared
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When the data will become available and for how long
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2 months after publication
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To whom data/document is available
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Journal that published the results
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Under which criteria data/document could be used
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A person/office that is legally in charge
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From where data/document is obtainable
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Yazd Reproductive Sciences Institute
983538247085
saeideh_dashti@yahoo.com
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What processes are involved for a request to access data/document
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Submission of legal order
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Comments
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