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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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History
# Registration date Revision Id
2 2023-10-21, 1402/07/29 282765
1 2020-07-08, 1399/04/18 142365
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  • Protocol summary

    In the intervention group, one injection of 2 to 4 cc of intra-lipid serum 20% is stimulated once in 4-9 days and once a positive pregnancy test is performed. It is not prescribed in the pharmaceutical control 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
    در گروه مداخله یک نوبت تزریق 2 تا 4 سی سی سرم اینترا لیپید 20 درصد در روز های 4-9 تحریک و یک نوبت هم پس از تست بارداری مثبت انجام خواهد شد در گروه کنترل دارویی تجویز نمی شود
    در گروه مداخله یک نوبت تزریق 2 تا 4 سی سی سرم اینترا لیپید 20 درصد در روزقبل از تجویز پروژسترون در سیکل برنامه ریزی جنین فریز و یک نوبت هم پس از تست بارداری مثبت انجام خواهد شد در گروه کنترل دارویی تجویز نمی شود

  • General information

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    2020-03-18, 1398/12/28
    2020-12-28, 1399/10/08
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    2020-08-10, 1399/05/20
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    2022-09-11, 1401/06/20
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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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    تاریخ شروع بیمارگیری تغییر کرده است . حجم نمونه زیاد شده است وچون ما تولد زنده را هم بررسی کردیم مدت زمان طرح افزایش یافته است

  • Intervention groups

    #1
    Intervention group: In this group, in 4 to 9 days of stimulation, one injection of 2 to 4 cc of Intra Lipid serum will be performed, 20% related to Sina Pakhsh Saba Company, and another time will be performed with the same dose after a positive pregnancy test.
    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.
    گروه مداخله: در این گروه در روز های 4 تا 9 تحریک یک نوبت تزریق 2 تا 4 سی سی سرم اینترا لیپید 20 درصد مربوط به شرکت سینا پخش صبا و یک نوبت دیگر هم با همین دوز پس از تست بارداری مثبت انجام خواهد شد
    گروه مداخله: در این گروه در روز قبل از تجویز پروزسترون در سیکل برنامه ریزی جنین فریز یک نوبت تزریق 2 تا 4 سی سی سرم اینترا لیپید 20 درصد مربوط به شرکت سینا پخش صبا و یک نوبت دیگر هم با همین دوز پس از تست بارداری مثبت انجام خواهد شد

Protocol summary

Study aim
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
Design
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
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
Chemical pregnancy - clinical pregnancy - abortion

General information

Reason for update
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
Acronym
IRCT registration information
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
Registration date
2020-07-08, 1399/04/18
Registrant information
Name
Azade Khazaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3761 5166
Email address
azadekhazaie@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-28, 1399/10/08
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
2020-08-10, 1399/05/20
Actual recruitment end date
2022-09-11, 1401/06/20
Trial completion date
empty
Scientific title
The effect of immunotherapy with injectable intervalipide in improving pregnancy outcomes in patients with a history of recurrent implantation failure in assisted reproductive therapies
Public title
Investigation of the effect of interlipid in patients with a history of recurrent implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 40
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Blinding (investigator's opinion)
Triple blinded
Blinding description
The researcher does not know how to randomize.The patient and the results evaluator are not aware of the assigned group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of mashhad university of medical sciences
Street address
Dahdee Square - Razi Sharghi St. - Milad Infertility Center
City
mashhad
Province
Razavi Khorasan
Postal code
9178631973
Approval date
2016-11-02, 1395/08/12
Ethics committee reference number
ir.mums.fm.rec.1395.366

Health conditions studied

1

Description of health condition studied
reccurent implantation failure in assisted reproductive therapies
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
chemical pregnancy rate
Timepoint
Two weeks after embryo transfer
Method of measurement
serum bhcg level

2

Description
clinical pregnancy rate
Timepoint
6 weeks after embryo transfer
Method of measurement
sonography

3

Description
abortion rate
Timepoint
Pregnancy loss before 12 weeks of pregnancy
Method of measurement
sonography

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
milad infertility center
Full name of responsible person
azade khazaei
Street address
Dehdee Square - Razi Sharghi Street
City
mashhad
Province
Razavi Khorasan
Postal code
9178631973
Phone
+98 51 3853 6169
Email
azadekhazaie@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
dr mohsen tafaghodi
Street address
University Street - Mashhad University of Medical Sciences
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3538 3841
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
malihe mahmodi nia
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Deh Dey Square - Razi Sharghi St. - Milad Infertility Center
City
mashhad
Province
Razavi Khorasan
Postal code
9178631973
Phone
+98 51 3853 6169
Email
mahmoudiniam@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
malihe mahmodinia
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Deh Dey Square - Razi Sharghi St. - Milad Infertility Center
City
mashhad
Province
Razavi Khorasan
Postal code
9178631973
Phone
+98 51 3853 6169
Email
mahmoudiniam@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
nayere khadem
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ibn Sina St. - Imam Reza Hospital
City
mashhad
Province
Razavi Khorasan
Postal code
9178631973
Phone
+98 51 3852 5305
Email
khademn@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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