Protocol summary
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Study aim
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The aim of our study is to compare the pregnancy outcomes of cryopreserved embryos transfer in cleavage with blastocyst stage in patients with the history of recurrent implantation failure.
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Design
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A non randomized, not blinded, controlled clinical trial with a parallel group design of 100 patients.
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Settings and conduct
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This non randomized clinical trial will be done at Yazd Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, All women had previously undergone in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI) with embryo cryopreservation and have the history of repeated implantation failure. The patients are divided into group I (blastocyst group) and group II (cleavage group) at the time of disclosing the sealed envelopes by computerized randomization.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: women who will be undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with the cryopreserved embryo with history of recurrent implantation failure
Exclusion criteria: women with the history of sever endometriosis; endocrine disorders; or hysteroscopic surgery;sever male factor
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Intervention groups
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Intervention: Transfer of frozen embryo after culture in the medium in blastocyst stage.
Control: Transfer of frozen embryo in the cleavage stage.
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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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Update based on the latest methodology changes
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110509006420N16
Registration date:
2018-07-30, 1397/05/08
Registration timing:
prospective
Last update:
2021-07-01, 1400/04/10
Update count:
1
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Registration date
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2018-07-30, 1397/05/08
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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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2018-07-23, 1397/05/01
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Expected recruitment end date
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2019-01-21, 1397/11/01
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Actual recruitment start date
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2018-08-06, 1397/05/15
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Actual recruitment end date
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2019-02-04, 1397/11/15
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Trial completion date
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2019-11-15, 1398/08/24
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Scientific title
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The pregnancy outcome after blastocyst transfer in women with the history of repeated implantation failure in frozen-thawed cycles
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Public title
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Blastocyste transfer in patients with history of 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:
Women use frozen embryo transfer
History of repeated implantation failure
have a minimum of three good quality cryopreserved embryos
Exclusion criteria:
History of severe endometriosis
History of severe male factor infertility
History of endocrine disorder
History of hysteroscopic surgery
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Age
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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:
96
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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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2017-11-22, 1396/09/01
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Ethics committee reference number
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IR.SSU.RSI.REC.1396.9
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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15 days after embryo transfer
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Method of measurement
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Blood laboratory kit
2
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Description
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Clinical pregnancy
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Timepoint
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3 weeks after positive beta-h Cg
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Method of measurement
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Observation of fetal heart activity by transvaginal ultrasonography
Secondary outcomes
1
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Description
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Miscarriage rate
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Timepoint
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Loss of pregnancy before 20 gestational week
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Method of measurement
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Absence of fetal heart activity in ultra sound sonography
Intervention groups
1
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Description
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Intervention group: Thawing will be done at least 2 months after cryopreservation. All embryos in group 1 (blastocyst group) transfer to media and extended culturewill be done for 3 days until blastocyst development. Endometrial preparation will be done by estradiol valerate (Aburaihan,Iran) consumption orally at the dose of 6 mg per day from the second day of the menstrual cycle. In day13 of the cycle, an ultrasound examination will be perform. When the endometrial thickness reaches more than 8 mm in diameter, 400 mg vaginal progesterone(Aburaihan,Iran) will be used 2 times daily. Transfer of embryos will be done done 3 days after thawing and thawing will be done 2 days after progesterone injection. Estradiol and progesterone consumption will be continued until the documentation of fetal heart activity by ultrasound.
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Category
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Treatment - Other
2
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Description
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Control group: Thawing will be done at least 2 months after cryopreservation. All embryos in group 2 (cleavage group) are transferred to the uterine cavity 2 hours after thawing. Endometrial preparation will be done by estradiol valerate(Aburaihan,Iran) consumption orally at the dose of 6 mg per day from the second day of the menstrual cycle. In day13 of the cycle, an ultrasound examination will be performed. When the endometrial thickness reaches more than 8 mm in diameter, 400 mg progesterone(Aburaihan,Iran) vaginally will be used 2 times in a day. Thawing will be done 2 days after progesterone injection. Estradiol and progesterone consumption is continued until the documentation of fetal heart activity by ultrasound.
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Category
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Treatment - 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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Yazd 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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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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Due to the privacy of patients
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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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No - There is not 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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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
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Title and more details about the data/document
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The study protocol, the statistical analysis map, the clinical study report will be available after publishing of the article.
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When the data will become available and for how long
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After publishing the article
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To whom data/document is available
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Researchers working in academic institutions
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Under which criteria data/document could be used
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use in the retrospective study
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From where data/document is obtainable
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Yazd research and clinical center for infertility
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What processes are involved for a request to access data/document
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Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, request is referred to the research experts and then get the data.
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Comments
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