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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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History
# Registration date Revision Id
3 2022-04-10, 1401/01/21 222451
2 2021-12-12, 1400/09/21 219344
1 2017-10-07, 1396/07/15 26361
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  • General information

    Double blinded
    Triple blinded
    2018-02-01, 1396/11/12
    2019-12-31, 1398/10/10

  • Primary outcomes

    #1
    check the fetus heart rate ,
    check the pregnancy sac ,
    رویت ضربان قلب جنین
    رویت ساک حاملگی
    #2
    empty
    check the fetus heart rate
    empty
    رویت ضربان قلب جنین
    empty
    7 weeks after intervention
    empty
    7 هفته بعد از مداخله
    empty
    sonography
    empty
    سونوگرافی

  • Secondary outcomes

    #1
    Intrauterine pregnancy diagnosis
    ongoing Intrauterine pregnancy diagnosis
    تشخیص حاملگی داخل رحم
    تشخیص ادامه حاملگی داخل رحم
    4 weeks after intervention
    During pregnancy
    4 هفته بعد از مداخله
    طی حاملگی
    By ultrasound
    sonography
    #2
    empty
    ectopic pregnancy
    empty
    حاملگی خارج رحم
    empty
    During pregnancy
    empty
    حین بارداری
    empty
    sonography
    empty
    سونوگرافی
    #3
    empty
    abortion
    empty
    سقط
    empty
    During pregnancy
    empty
    حین بارداری
    empty
    sonography
    empty
    سونوگرافی
    #4
    empty
    live birth
    empty
    تولد زنده
    empty
    end of pregnancy
    empty
    خاتمه بارداری
    empty
    child birth
    empty
    زایمان

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Jafar Mohseni
    Full name of responsible person - Persian: دکتر جعفر محسنی
    Street address - English: ACECR Research center, Do Kamal Ave.
    Street address - Persian: خیابان دوکمال، مرکز تحقیقات جهاد دانشگاهی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5163963173
    Phone: +98 41 3658 8229
    Fax:
    Email: baybordi@acecr.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Jafar Mohseni
    Full name of responsible person - Persian: دکتر جعفر محسنی
    Street address - English: ACECR Research center, Do Kamal Ave.
    Street address - Persian: خیابان دوکمال، مرکز تحقیقات جهاد دانشگاهی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5163963173
    Phone: +98 41 3658 8229
    Fax:
    Email: jmohseni46@gmail.com
    Web page address:

Protocol summary

Study aim
determining the effect of platelet rich plasma on the improvement of pregnancy outcomes in repeated implantation failure
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
Intervention group: Intrauterine injection of autologous platelet rich plasma; control group: standardized fertility treatment
Main outcome variables
Blood βHCG hormone; pregnancy sac and fetus heart rate in sonography

General information

Reason for update
data correction about sample size and IRCT update
Acronym
IRCT registration information
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
Registration date
2017-10-07, 1396/07/15
Registrant information
Name
Elaheh Baybordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7924
Email address
baybordi@acecr.ac.ir
Recruitment status
Recruitment complete
Funding source
All costs are the responsibility of East Azarbaijan ACECR Organization.
Expected recruitment start date
2017-05-01, 1396/02/11
Expected recruitment end date
2018-02-01, 1396/11/12
Actual recruitment start date
2017-05-01, 1396/02/11
Actual recruitment end date
2018-02-01, 1396/11/12
Trial completion date
2019-12-31, 1398/10/10
Scientific title
Effect of autologous platelet-rich plasma on improving pregnancy outcomes in repeated implantation failure: A randomized controlled trial
Public title
Effect of autologous platelet-rich plasma on improving pregnancy outcomes in repeated implantation failure :A randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 118
Actual sample size reached: 94
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Triple blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research Institute of Royanَ , ACECR
Street address
Hafez Alley,North Bani Hashem ST,Resalat High Way
City
Tehran
Province
Tehran
Postal code
148- 16635
Approval date
2017-08-15, 1396/05/24
Ethics committee reference number
IR.ACECR.ROYAN.REC.1396.183

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N98.3
ICD-10 code description
Complications of attempted introduction of embryo in embryo transfer

Primary outcomes

1

Description
Positive pregnancy report with βHCG laboratory confirmed
Timepoint
4 weeks after intervention
Method of measurement
Measurement of βHCG hormone (mg / dl) by the Laboratory

2

Description
check the pregnancy sac ,
Timepoint
3 weeks after the check of positive HCG
Method of measurement
sonography

3

Description
check the fetus heart rate
Timepoint
7 weeks after intervention
Method of measurement
sonography

Secondary outcomes

1

Description
ongoing Intrauterine pregnancy diagnosis
Timepoint
During pregnancy
Method of measurement
sonography

2

Description
ectopic pregnancy
Timepoint
During pregnancy
Method of measurement
sonography

3

Description
abortion
Timepoint
During pregnancy
Method of measurement
sonography

4

Description
live birth
Timepoint
end of pregnancy
Method of measurement
child birth

Intervention groups

1

Description
intervention group: Injection of autologous platelet-rich plasma into the uterine cavity before embryos are transferred into the uterine cavity
Category
Treatment - Other

2

Description
Control group: the standard procedure and without autologous platelet-rich plasma injection, the embryos are transferred into the uterine cavity
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
East Azarbaijan ACECR infertility treatment center
Full name of responsible person
Dr Elaheh Baybordi
Street address
East Azarbaijan ACECR infertility treatment center, Jaam e Jam AVE
City
Tabriz
Province
East Azarbaijan
Postal code
5163963173
Phone
+98 41 3332 5730
Email
baybordi@acecr.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr. Jafar Mohseni
Street address
ACECR Research center, Do Kamal Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163963173
Phone
+98 41 3658 8229
Email
jmohseni46@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
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
ACECR
Full name of responsible person
Dr Jafarzadeh
Position
ACECR Infertility treatment center managment
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
ACECR Infertility treatment center,Jame Jam AVE
City
Tabriz
Province
East Azarbaijan
Postal code
5163963173
Phone
+98 41 3329 5730
Fax
Email
sjafarzadeh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
ACECR
Full name of responsible person
Dr Elaheh Baybordi
Position
assistant professor of community medicine
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
ACECR Infertility treatment center,Jaame jam Ave
City
تبریز
Province
East Azarbaijan
Postal code
5163963173
Phone
+98 41 3337 5188
Fax
Email
baybordi@acecr.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
ACECR
Full name of responsible person
Dr Elaheh Baybordi
Position
community medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Street address
ACECR Infertility treatment center
City
Tabriz
Province
East Azarbaijan
Postal code
5163963173
Phone
+98 41 3337 5188
Fax
Email
baybordi@acecr.ac.ir
Web page address

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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
he completed questionnaire can be used
When the data will become available and for how long
3 months after publication
To whom data/document is available
infertility researchers
Under which criteria data/document could be used
research
From where data/document is obtainable
Elaheh Baybordi, baybordi@acecr.ac.ir
What processes are involved for a request to access data/document
after receiving the email
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