Protocol summary
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Study aim
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Comparison of sequential transfer of one cleavage and one blastocyst embryo, whit transfer of two cleavage embryos, in increasing implantation rate in ART cycles
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Design
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Phase 3 clinical trial with a control group will be conducted in parallel groups on 140 patients. Randomization of the samples will be done with a simple randomization method according to the generated list. The list of random numbers will be generated by a statistical consultant using Random Allocation1 software. 70 patients will be in the intervention group and 70 patients will be in the control group.
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Settings and conduct
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The clinical trial will be conducted in Yazd Infertility Research Center. The study and control cases will be selected among patients referring to the infertility clinic who are candidates for IVF. Patients who have two to five embryos in the IVF process after ovarian stimulation and oocyte puncture, and eligible for fresh embryo transfer, are randomly divided into two groups; sequential transfer of one cleavage embryo and one blastocyst group and simultaneous transfer of two cleavage embryos group. Blinding is not performed.
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Participants/Inclusion and exclusion criteria
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Infertile women aged 18-42, candidate for IVF/ICSI and eligible for fresh embryo transfer,with limitted number of embryos(2-5) whithout any structural or anathomical uterine problems.
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Intervention groups
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Both groups will be selected from infertile women candidate for IVF/ICSI and eligible for fresh embryo transfer.2 to 3 days after oocyte puncture, patients will return to know the number of their embryos. Patients who have a minimum of two and a maximum of five embryos will be randomly divided into two groups. Intervention group: sequential transfer of one cleavage embryo and one blastocyst embryo. Control group: transfer of two cleavage stage embryos at the same time.
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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 recruitment and termination of the clinical trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110509006420N26
Registration date:
2023-08-27, 1402/06/05
Registration timing:
registered_while_recruiting
Last update:
2024-03-30, 1403/01/11
Update count:
1
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Registration date
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2023-08-27, 1402/06/05
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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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2023-08-27, 1402/06/05
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Expected recruitment end date
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2024-01-05, 1402/10/15
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Actual recruitment start date
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2023-08-23, 1402/06/01
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Actual recruitment end date
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2024-01-20, 1402/10/30
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Trial completion date
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2024-03-05, 1402/12/15
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Scientific title
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Effect of sequential cleavage and blastocyst embryo transfer compared to one step cleavage embryo transfer on Assisted Reproductive Technology(ART) outcome of patients with at least two and maximum of five embryos, A randomized clinical trial
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Public title
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Sequential transfer of a day 2/3 embryo and day 5/6 embryo compared to one step two day 2/3 embryo transfer
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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 candidate for oocyte puncture and fresh embryo transfer with minimum of two and maximum of five embryos
Exclusion criteria:
Women with structural and anatomical uterine abnormalities
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Age
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From 18 years old 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, randomization list of samples in groups will be generated using Random Allocation1 software. Then, according to the order of patient's referral and taking into account the criteria for entering the study, according to the patient's entry number from the list, the study group is announced to the researcher by the statistical consultant, and on each sample according to the study group , the intervention is done or they are placed in the control 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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2023-08-06, 1402/05/15
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Ethics committee reference number
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IR.SSU.RSI.REC.1402.008
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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Observation of fetal heart activity by transvaginal ultrasonography
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 blood sample Beta Hcg
2
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Description
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Early misscariage rate
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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 heart activity in ultrasound
3
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Description
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Ectopic pregnancy
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Timepoint
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After positive result for chemical pregnancy
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Method of measurement
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No rise in serum Beta Hcg level and not visualizing intra uterine gestetianal sac in Trans Vaginal Ultrasound
Intervention groups
1
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Description
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Intervention group: Infertile women candidate for IVF/ICSI, if they are eligible for fresh embryo transfer, and the number of their embryos is at minimum of two and maximum of five, after obtaining a written consent, they will undergo sequential embryo transfer. In this way, in the first step, a cleavage stage embryo will be transferd. After two to three days, transfer of the second embryo as a blastocyst will be done .
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Category
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Treatment - Other
2
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Description
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Control group: Infertile women candidate for IVF/ICSI, if they are eligible for fresh embryo transfer, and the number of their embryos is at minimum of two and maximum of five, will undergo one step embryo transfer. Two cleavage stage embryo will be transfer for them.
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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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Researchers working in academic centers
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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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Submit your request by sending an email. Nahid.homayoon@hotmail.com
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What processes are involved for a request to access data/document
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By reviewing the researcher's request and providing sufficient documentation of their research and the reason for using the data, it can be provided within a week.
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Comments
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