The effect of platelet-rich plasma on endometrial thickness and pregnancy rate in repeated implantation failure patients (RIF) , A clinical trial study
The aim of this study was to investigate the effects of platelet-rich plasma (PRP) on endometrial thickness and quality, and also on pregnancy rate.
Design
not blinded, sham controlled clinical trial study with per-test and post-test
Settings and conduct
Sixty patients referred to Afzalipour Hospital, who had a history of implant failure, performed the clinical trial study. The PRP, taken from the patient's blood, was injected into the uterine cavity through a Tomcat catheter after two stages of centrifugation.
Participants/Inclusion and exclusion criteria
All RIF patients aged 20-45 years having no history of immunological, hematological or hormonal disorders, congenital or acquired uterine abnormalities, and chromosomal and genetic abnormalities were included in this study.
Intervention groups
Sixty RIF patients completed this clinical trial study. PRP extracted by the patient's blood and after two centrifuges step, infused into the uterine cavity through a Tomcat catheter.
The effect of platelet-rich plasma on endometrial thickness and pregnancy rate in repeated implantation failure patients (RIF) , A clinical trial study
Public title
Investigating the effect of PRP injection on increasing endometrial thickness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Repeated Implantation Failure patients (RIF)
Exclusion criteria:
history of immunological disorders
hematological disorders
hormonal disorders
congenital or acquired uterine abnormalities
chromosomal and genetic abnormalities
Age
From 20 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
72
Actual sample size reached:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethic Committee of Kerman University of Medical Sciences
Street address
Tahmaseb-abad cross- Jahad Street, Vice Resrach Building of kerman University of Medical Sciences,
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2017-05-05, 1396/02/15
Ethics committee reference number
IR.KMU.REC1396.2007
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Increased Endometrial Thickness
Timepoint
Before and after PRP infusion, and in embryo transfer day
Method of measurement
Ultrasound
2
Description
successful embryo implantation
Timepoint
After transferring the fetus into the uterus
Method of measurement
pregnancy test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: . PRP extracted by the patient's blood and after two centrifuges step, infused into the uterine cavity through a Tomcat catheter.
Category
Treatment - Drugs
2
Description
Intervention group: Endometrial thickness changes were measured in three stages before and after PRP infusing and in embryo transfer day by ultrasound.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Fatemeh Amiri
Street address
Imam Highway
City
Kerman
Province
Kerman
Postal code
7616913439
Phone
+98 34 3132 8000
Email
amiri.f.986@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Victoria Habibzadeh
Street address
Imam Khomeini Highway (RA), next to Shahid Bahonar University, Afzalipour Medical Education Center
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8000
Email
V.habibzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Amiri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alley 27, Jahad Street
City
Kerman
Province
Kerman
Postal code
76198-45153
Phone
+98 34 3272 0997
Email
amiri.f.986@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Amiri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alley 27, Jahad Street
City
Kerman
Province
Kerman
Postal code
76198-45153
Phone
+98 34 3272 0997
Email
amiri.f.986@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fateme َAmiri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jahad street
City
Kerman
Province
Kerman
Postal code
76198-45153
Phone
+98 34 3247 5743
Fax
Email
amiri.f.986@gmail.com
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