Protocol summary
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Study aim
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determining the effect of platelet rich plasma on the improvement of pregnancy outcomes in repeated implantation failure
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Design
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A randomized; double-blind; controlled trial, with 118 cases in two intervention or control groups, parallel-group, phase 3, randomization with use of sealed envelopes.
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Settings and conduct
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Tabriz jihad daneshgahi ART center, Endometrial thickness is measured by trans vaginal ultrasound. In the intervention group, intrauterine injections of PRP are performed. PRP is prepared from autologous blood by centrifugation, and 0.5 to1 ml of PRP is injected into the uterine cavity. After 48 hours of PRP injection, the embryos are transferred to the uterine cavity in the blastocyst stage. In the control group, the standard treatment will done to transfer the embryo to the uterine cavity without intrauterine infusion of PRP.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: women 18-45 years old; with a history of RIF during ART treatments. Exclusion criteria: pregnancy, diagnosed cancers, hemoglobin less than 11 gr per decilitre, platelets less than 150,000 per cc, use of anticoagulants, use of NSAID up to 10 days before the procedure, any physical or mental illness that affects the participant's immunity and admission.
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Intervention groups
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Intervention group: Intrauterine injection of autologous platelet rich plasma;
control group: standardized fertility treatment
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Main outcome variables
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Blood βHCG hormone; pregnancy sac and fetus heart rate in sonography
General information
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Reason for update
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data correction about sample size and IRCT update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017061434525N1
Registration date:
2017-10-07, 1396/07/15
Registration timing:
registered_while_recruiting
Last update:
2022-04-12, 1401/01/23
Update count:
2
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Registration date
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2017-10-07, 1396/07/15
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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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All costs are the responsibility of East Azarbaijan ACECR Organization.
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Expected recruitment start date
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2017-05-01, 1396/02/11
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Expected recruitment end date
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2018-02-01, 1396/11/12
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Actual recruitment start date
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2017-05-01, 1396/02/11
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Actual recruitment end date
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2018-02-01, 1396/11/12
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Trial completion date
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2019-12-31, 1398/10/10
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Scientific title
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Effect of autologous platelet-rich plasma on improving pregnancy outcomes in repeated implantation failure: A randomized controlled trial
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Public title
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Effect of autologous platelet-rich plasma on improving pregnancy outcomes in repeated implantation failure :A randomized controlled trial
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women of childbearing age (18-45 yrs)
A history of RIF (repeated implantation failure) during ART(Assisted reproductive technology ) treatments
Exclusion criteria:
pregnancy,
Diagnosed cancers,
Hemoglobin less than 11 gr per deciliter,
Patelets less than 150,000/ cc,
Use of anticoagulants,
Use of Non-steroidal anti-inflammatory drugs up to 10 days before the procedure,
Any physical or mental illness that affects the patient's immunity and admission and disrupts the process of project implementation and patient follow-up.
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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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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
118
Actual sample size reached:
94
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The method is simple randomization and using the tool of sealed envelopes. Participants select one of the envelopes and deliver it to the relevant observer. The letters A and B are written inside the envelope and the participants are divided into two groups.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Patients are unaware of the assignment to the groups. The examining physician and sonographer are unaware of the assignment of the patient to the groups. The analyzer is only aware of groups A and B and is not aware of the control and intervention group.
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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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2017-08-15, 1396/05/24
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Ethics committee reference number
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IR.ACECR.ROYAN.REC.1396.183
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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N98.3
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ICD-10 code description
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Complications of attempted introduction of embryo in embryo transfer
Primary outcomes
1
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Description
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Positive pregnancy report with βHCG laboratory confirmed
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Timepoint
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4 weeks after intervention
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Method of measurement
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Measurement of βHCG hormone (mg / dl) by the Laboratory
2
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Description
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check the pregnancy sac ,
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Timepoint
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3 weeks after the check of positive HCG
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Method of measurement
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sonography
3
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Description
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check the fetus heart rate
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Timepoint
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7 weeks after intervention
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Method of measurement
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sonography
Secondary outcomes
1
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Description
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ongoing Intrauterine pregnancy diagnosis
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Timepoint
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During pregnancy
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Method of measurement
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sonography
2
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Description
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ectopic pregnancy
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Timepoint
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During pregnancy
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Method of measurement
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sonography
3
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Description
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abortion
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Timepoint
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During pregnancy
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Method of measurement
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sonography
4
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Description
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live birth
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Timepoint
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end of pregnancy
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Method of measurement
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child birth
Intervention groups
1
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Description
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intervention group: Injection of autologous platelet-rich plasma into the uterine cavity before embryos are transferred into the uterine cavity
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Category
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Treatment - Other
2
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Description
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Control group: the standard procedure and without autologous platelet-rich plasma injection, the embryos are transferred into the uterine cavity
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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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Iranian academic center for education culture and research
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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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Undecided - It is not yet known if there will be 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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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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he completed questionnaire can be used
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When the data will become available and for how long
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3 months after publication
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To whom data/document is available
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infertility researchers
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Under which criteria data/document could be used
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research
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From where data/document is obtainable
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Elaheh Baybordi,
baybordi@acecr.ac.ir
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What processes are involved for a request to access data/document
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after receiving the email
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Comments
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