Protocol summary
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Study aim
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Comparison of the effect of transferring two embryos in the blastocyst stage and sequential transfer of one cleaved blastocyst embryo on pregnancy outcomes in patients who are candidates for frozen embryo transfer and have a history of repeated implantation failure.
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Design
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The phase 3 clinical trial, with a control group, will be conducted in parallel on 140 patients. The randomization of the samples will be done with Weber's simple randomization method according to the generated list of random numbers. The list of random numbers will be generated using the Random Allocation 1 software by A statistical consultant will be produced.
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Settings and conduct
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This study is conducted by the clinical trial method in Yazd Research Institute of Reproductive Sciences. The studied and control cases will be selected from among the people with poor ovarian response referring to the infertility clinic who are candidates for assisted reproductive methods. People who meet the criteria for entering the study are divided into two groups: blastocyst and sequential transfer.
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Participants/Inclusion and exclusion criteria
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Women under 45 years of age with frozen embryos and a history of 2 implantation failures
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Intervention groups
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Eligible people who have at least 4 frozen embryos are randomly placed in two consecutive transfer groups of one cleavage embryo and one blastocyst embryo and two blast embryos. In the blastocyst group 5 days after the start of progesterone and in the consecutive group once 3 days after the start Progesterone and once 5 days after the start of progesterone, embryo transfer takes place
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Main outcome variables
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Clinical pregnancy
General information
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Reason for update
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End of patient admission and end of clinical trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110509006420N27
Registration date:
2024-01-27, 1402/11/07
Registration timing:
prospective
Last update:
2024-12-23, 1403/10/03
Update count:
2
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Registration date
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2024-01-27, 1402/11/07
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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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2024-01-30, 1402/11/10
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Expected recruitment end date
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2024-08-22, 1403/06/01
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Actual recruitment start date
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2024-02-04, 1402/11/15
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Actual recruitment end date
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2024-08-05, 1403/05/15
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Trial completion date
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2024-11-05, 1403/08/15
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Scientific title
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Comparison of the effect of tow embryo transfer in the stage of blastocyst and sequential transfer of a cleavage-a blastocyst embryo on pregnancy outcomes Patients who are candidates for frozen embryo transfer and recurrent implantation failure; a randomized clinical trial
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Public title
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Comparison of the effect of tow embryo transfer in the stage of blastocyst and sequential transfer of a cleavage-a blastocyst embryo on pregnancy outcomes Patients who are candidates for frozen embryo transfer and recurrent implantation failure; a randomized clinical trial
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Candidates for frozen embryo transfer
Failure of more than 2 implants
The number of frozen embryos is at least four
Women under the age of 45
Exclusion criteria:
Uncontrolled endocrine diseases (diabetes, hyperthyroid and hypothyroid)
Egg donation
Uncontrolled autoimmune diseases (lupus and rheumatoid arthritis)
Severe uterine adenomyosis
Sever Asherman
Untreated hydrosalpinx
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Age
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To 45 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:
140
Actual sample size reached:
140
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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 study, using the simple randomization method using the Random Allocation1 software (http://random-allocation software.informer.com\1) and based on the simple randomization method, the list of samples in the two groups studied by the expert Statistics will be generated. In this software, in order to generate a list of random numbers, first specify the number of groups to be studied as 2 and the total number of samples required as 140 people, and then from the list of sample randomization methods, the method (simple randomization method in parallel group) by considering the same number of samples in the groups. Then a random list will be generated based on the groups and the number of samples in each group. Randomly and after obtaining informed consent by the researcher, they are assigned to two groups. The sealed envelope method is used for concealment. Then a random list will be generated based on the number of samples in each group
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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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2024-01-10, 1402/10/20
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Ethics committee reference number
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IR.SSU.RSI.REC.1402.020
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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Clinical pregnancy
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Timepoint
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4 weeks after embryo transfer
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Method of measurement
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Sonography
Secondary outcomes
1
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Description
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Chemical pregnancy
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Timepoint
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Two weeks after embryo transfer
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Method of measurement
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Through the measurement of BHCG
2
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Description
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Twin pregnancy
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Timepoint
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In the 6th week of pregnancy
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Method of measurement
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Observation of two gestational sacs in vaginal ultrasound
3
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Description
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The rate of premature abortion
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Timepoint
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Ten weeks after embryo transfer
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Method of measurement
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Absence of fetal heartbeat in sonography
4
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Description
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Ectopic pregnancy
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Timepoint
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After proving chemical pregnancy
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Method of measurement
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Not increasing beta hCG titer and not seeing pregnancy sac in vaginal ultrasound
Intervention groups
1
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Description
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Intervention group: Infertile people who are candidates for frozen embryo transfer with a history of two implantation failures, if their number of embryos is at least 4, after obtaining a written consent, embryo transfer will be done for them consecutively. In this way, in the first stage, an embryo is cleaved and two to three days after the transfer of the first embryo, the transfer of the second embryo is done in the form of a blast.
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Category
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Treatment - Other
2
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Description
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Control group: Infertile candidates for frozen embryo transfer with a history of twice implantation failure, if their number of embryos is at least 4, after obtaining a written consent, they will undergo embryo transfer in one step. In this way, two blastocyst embryos will be transferred to them at the same time.
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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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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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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
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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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In order to receive data or other study documents, researchers working in academic and scientific institutions are allowed to apply
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Under which criteria data/document could be used
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To evaluate the accuracy of the data and use data to complete other researches
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From where data/document is obtainable
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Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran
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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, the request is referred to the research experts and then get the data.
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Comments
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