Protocol summary
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Study aim
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Investigation of the effect of immunotherapy with injectable interlipid in improving pregnancy outcomes in patients with a history of recurrent implantation failure in assisted reproductive therapies
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Design
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Random allocation to intervention and control groups in the form of random blocking of the two-way blind type with a sample size of 40 naf
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Settings and conduct
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This study is being conducted at the Milad Infertility Center affiliated to Mashhad University of Medical Sciences and includes infertile patients with a history of recurrent implantation failure who have the conditions to study and are willing to enter the study.Patients are randomly divided into two equal groups (20 people each).In the intervention group, one injection of 2 to 4 cc of intralipid 20% in 4-9 days will be stimulated and one injection will be performed with the same dose after a positive pregnancy test, and routine measures will be performed in the control group.
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Participants/Inclusion and exclusion criteria
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Entry criteria: All patients referred to Milad Infertility Center with a history of repeated implantation fractures
Lack of entry criteria: history of fibroids, polyps, endometriosis, hydrocephalus, fat metabolism disorders, egg and soy allergy, liver, kidney, lung disease, coagulation disorders, genetic diseases and chromosomal disorders, anatomical disorders, thrombophilia, infection
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Intervention groups
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intervention group, a dose of 2-4 mg 20% intralipid in 250 ml normal saline (Sina Pakhsh Saba Co.Tehran,Iran)was injected a day before progesterone administration and the second dose was given after a positive test of pregnancy
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Main outcome variables
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Chemical pregnancy - clinical pregnancy - abortion
General information
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Reason for update
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The study start date has changed. The sample size has increased, and since we also examined live births, the duration of the study has increased
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200615047781N1
Registration date:
2020-07-08, 1399/04/18
Registration timing:
prospective
Last update:
2023-10-22, 1402/07/30
Update count:
1
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Registration date
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2020-07-08, 1399/04/18
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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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2020-12-28, 1399/10/08
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Expected recruitment end date
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2021-03-18, 1399/12/28
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Actual recruitment start date
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2020-08-10, 1399/05/20
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Actual recruitment end date
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2022-09-11, 1401/06/20
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Trial completion date
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empty
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Scientific title
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The effect of immunotherapy with injectable intervalipide in improving pregnancy outcomes in patients with a history of recurrent implantation failure in assisted reproductive therapies
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Public title
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Investigation of the effect of interlipid in patients with a history of recurrent 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:
Patients referred to Milad Infertility Center in Mashhad with a history of repeated implantation failure
Exclusion criteria:
History of fibroids
endometrial polyp
endometriosis
Hydrosalpangs
Fat metabolism disorder
Allergies to eggs and soy
liver disease
renal disease
pulmonary disease
Blood coagulation disorder
Genetic diseases and chromosomal disorders
anatomic disorders
vaginal infections
hormonal disorders
trombophilia
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Age
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No age limit
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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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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
40
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random allocation list using pass software.The type of randomization is simple, and the analyst and physician will be unaware of the intervention and control 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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The researcher does not know how to randomize.The patient and the results evaluator are not aware of the assigned 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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2016-11-02, 1395/08/12
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Ethics committee reference number
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ir.mums.fm.rec.1395.366
Health conditions studied
1
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Description of health condition studied
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reccurent implantation failure in assisted reproductive therapies
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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chemical pregnancy rate
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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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serum bhcg level
2
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Description
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clinical pregnancy rate
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Timepoint
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6 weeks after embryo transfer
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Method of measurement
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sonography
3
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Description
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abortion rate
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Timepoint
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Pregnancy loss before 12 weeks of pregnancy
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Method of measurement
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sonography
Intervention groups
1
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Description
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Intervention group: intervention group, a dose of 2-4 mg 20% intralipid in 250 ml normal saline (Sina Pakhsh Saba Co.Tehran, Iran)was injected a day before progesterone administration and the second dose was given after a positive test of pregnancy.
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Category
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Treatment - Drugs
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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Mashhad 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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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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Undecided - It is not yet known if there will be 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