Implantation is considered to be successful when the sac can be detected by ultrasound. Platelet-rich plasma (PRP) has been able to stimulate endometrial growth and improve the outcome of pregnancy in patients with repeated implantation failure.
This research team carry out a randomized double blind controlled trial, with 50 cases in two intervention and control groups, with the aim of determining the effect of platelet-rich plasma on the improvement of pregnancy outcomes in patients with repeated implantation failure.
Study Population: Patients referred to the ACECR Center for Infertility Therapy, who had repeated implantation failure.
Intervention: Intrauterine injection of autologous platelet-rich plasma.
After obtaining informed consent, patients will undergo standardized fertility treatment. 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 0.5-1 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. After 4 weeks, the level of hormones βHCG is measured in the blood sample of patients and pregnancy is confirmed by ultrasound examination. The patient is followed for 3 weeks to observe the embryonic heart rate and continue to monitor the pregnancy process.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061434525N1
Registration date:2017-10-07, 1396/07/15
Registration timing:registered_while_recruiting
Last update:
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
2017-10-07, 1396/07/15
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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 reproductive age between 18 and 45 with a history of failure of fertility treatment, repeated failure of implantation
Exclusion criteria: Age under 18 years of age and over 45 years
pregnancy , detectable cancers, hemoglobin less than 11 g / dl, Platelet less than 150,000 per cc. Use of anticoagulants, NSAIDs for up to 10 days before the procedure, any mental or physical illness that affects the patient's safety and acceptance and disrupts the patient's follow-up.
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
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
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
Secondary outcomes
1
Description
Intrauterine pregnancy diagnosis
Timepoint
4 weeks after intervention
Method of measurement
By ultrasound
Intervention groups
1
Description
Intervention group: Intrauterine injection of autologous platelet-rich plasma. After 48 hours, the embryo is transferred to 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
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
East Azarbaijan ACECR
Full name of responsible person
Dr. Jafar Mohseni
Street address
ACECR Research center, Do Kamal Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
East Azarbaijan ACECR
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
ACECR
Full name of responsible person
Dr Jafar zadeh
Position
ACECR Infertility treatment center managment
Other areas of specialty/work
Street address
ACECR Infertility treatment center,Jame Jam AVE
City
Tabriz
Postal code
Phone
+98 41 3329 5730
Fax
Email
s.jaafarzade@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
ACECR
Full name of responsible person
Dr Elaheh Baybordi
Position
community medicine specialist
Other areas of specialty/work
Street address
ACECR Infertility treatment center,Jaame jam Ave
City
Tabriz
Postal code
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
Other areas of specialty/work
Street address
ACECR Infertility treatment center
City
Tabriz
Postal code
Phone
+98 41 3337 5188
Fax
Email
baybordi@acecr.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)