Protocol summary
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Study aim
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Comparison of two embryo transfer methods in increasing implantation and pregnancy in assisted reproductive cycles
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Design
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A clinical trial with two parallel groups and a sample size of 260 people. Randomization will be done using random allocation1 software. Block randomization method will be done. Blinding will not be done.
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Settings and conduct
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It is done at Yazd Infertility Research Center.
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Participants/Inclusion and exclusion criteria
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Women 18 to 40 years old are candidates for frozen embryo transfer are included in the study , and cases of severe male infertility, including azoospermia and sperm from TESE or PESA, and a body mass index greater than 30 are excluded.
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Intervention groups
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The first intervention group receives 6 mg of oral estradiol daily from the second day of the cycle and on day 13 of the cycle, transvaginal ultrasound is performed. Embryo transfer takes place at the stage of 8-cell cleavage. The transfer is performed under the guidance of abdominal ultrasound.
The second intervention group receives 6 mg of oral estradiol from the second day of the cycle, and on the 13th cycle, transvaginal ultrasound is performed. Embryo transfer takes place in the 8-cell cleavage stage. Ultrasound measurement of uterine length is performed before transfer with vaginal ultrasound and the length of the catheter is adjusted based on the uteroservical length measured in the ultrasound.
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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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Update methodology changes
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110509006420N24
Registration date:
2021-12-08, 1400/09/17
Registration timing:
prospective
Last update:
2022-12-08, 1401/09/17
Update count:
2
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Registration date
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2021-12-08, 1400/09/17
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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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2021-12-06, 1400/09/15
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Expected recruitment end date
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2022-06-05, 1401/03/15
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Actual recruitment start date
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2021-12-21, 1400/09/30
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Actual recruitment end date
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2022-07-09, 1401/04/18
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Trial completion date
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2022-09-22, 1401/06/31
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Scientific title
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Comparison of fetal transfer results under abdominal ultrasound with fetal transfer based on previous measurement of uterine length with vaginal ultrasound in assisted reproductive cycles
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Public title
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fetal transfer under abdominal ultrasound compared with fetal transfer based on the previous measurement of uterine length
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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 who are candidates for frozen embryo transfer.
Exclusion criteria:
Severe male infertility includes cases of azoospermia and sperm from TESE or PESA
Body mass index more than 30
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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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N/A
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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:
260
Actual sample size reached:
260
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Each participant is assigned a number from 1 to 264, and then 9 blocks of 32 are considered, and then each block is randomly selected. In each block, the type of treatment protocol of the participants is determined. Randomization using software The random allocation 1 software will be a block randomization method. The randomization of samples in each block is independent, which is specified by the software, and the researchers do not know about the randomized list.
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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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2021-02-21, 1399/12/03
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Ethics committee reference number
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IR.SSU.RSI.REC.1399.047
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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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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Early Miscarriage rate
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Timepoint
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10 weeks after embryo transfer
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Method of measurement
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Absence of fetal heart activity in ultra sound sonography
2
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Description
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Implantation rate
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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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Calculated by the number of gestational sacs observed on ultrasound on the number of embryos transferred
3
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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
Intervention groups
1
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Description
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Intervention group: intervention group receives 6 mg of oral estradiol from the second day of the cycle, and on the 13th cycle, transvaginal ultrasound is performed. Embryo transfer takes place in the 8-cell cleavage stage. Ultrasound measurement of uterine length is performed before transfer with vaginal ultrasound and the length of the catheter is adjusted based on the uterocervical length measured in the ultrasound.
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Category
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Treatment - Other
2
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Description
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Intervention group: receives 6 mg of oral estradiol daily from the second day of the cycle and on day 13 of the cycle, transvaginal ultrasound is performed. Embryo transfer takes place at the stage of cleavage. Transfer is performed under the guidance of abdominal 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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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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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
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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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