Protocol summary

Study aim
To evaluate the effectiveness of platelet-rich plasma in improvement of pregnancy and implantation rate in women with history of repeated implantation failure.
Design
Clinical trial with total of 120 eligible women that randomly assigned into two equal parallel groups (intervention and control)through Balanced Block Randomization. (Block size=4).
Settings and conduct
After endometrial preparation for embryo transfer in both groups, In intervention group,48 hours before embryo transfer (ET), 20 ml of peripheral venous blood will be obtained by syringe pre-filled with 2ml of anticoagulant solution,and then will be centrifuged immediately at 170 g for 10 minutes to separate red blood cells.this plasma will be re_centrifuged at 340 g for 5 minutes to obtain platelet-rich plasma (PRP), that contained platelet 4-5 times more than peripheral blood. 0.5ml of PRP will be infused into the uterine cavity with IUI catheter and after 48 hours, ET will be done. In control group, ET will be done without intrauterine infusion of PRP. After 2 weeks of ET, serum Beta_human chorionic Gonadotropin ( β HCG) will be measured in all patients. This research will be done at Infertility Department Of Shariati Hospital, Tehran, Iran
Participants/Inclusion and exclusion criteria
Infertile 20-40 years old women that failed to conceive after three or more embryo transfer and have at least one frozen good - quality blastocyst- stage embryo,body mass index below 30 kg/m2, without Genetic, Chromosomal, Uterine, Immunologic, Hormonal and Hematologic disorders.
Intervention groups
In intervention group,48 hours before embryo transfer, 0.5ml of platelet-rich plasma will be infused into the uterine cavity with IUI catheter. In control group embryo transfer undergoing without intrauterine infusion of platelet-rich plasma.
Main outcome variables
Clinical Pregnancy Implantation Rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190503043454N1
Registration date: 2019-07-06, 1398/04/15
Registration timing: registered_while_recruiting

Last update: 2019-07-06, 1398/04/15
Update count: 0
Registration date
2019-07-06, 1398/04/15
Registrant information
Name
Parvaneh Lak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2249 8504
Email address
lakparvaneh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of intrauterine infusion of platelet_rich plasma on pregnancy outcome in patients with repeated implantation failure.
Public title
Efficacy of platelet_rich plasma on embryo implantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women between 20 -40 years old History of at least 3 or more failure in embryo transfer Have at least one frozen Blastocyst - stage embryo Body Mass Index below 30 kg/m2
Exclusion criteria:
Congenital or acquire uterine abnormalities Genetic or chromosomal abnormalities Immunologic disorders Hematologic disorders Hormonal disorders
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced Block Randomization (Block size=4): We prepare four balls,two A and two B.for first patient ,a nurse who does not know our plan for both A and B groups, selects one ball randomly from basket.for next patient this selection were done through remaining three balls.for third patient from remaining two balls and the last ball for the fourth patient, and then another block was selected.therefore our blocks show one of these pattern. (BAAB) (BABA) (ABBA) (BBAA) (ABAB) (AABB)
Blinding (investigator's opinion)
Not 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 of Tehran University of Medical Sciences
Street address
Room 605, Floor 6 , Central Building Of Tehran University Of Medical Science., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-08-09, 1396/05/18
Ethics committee reference number
86388

Health conditions studied

1

Description of health condition studied
Repeated Implantation Failure
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Clinical Pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
To detect gestational sac with Fetal Heartbeat by Trans Vaginal Ultrasound.

2

Description
The Implantation Rate
Timepoint
Four weeks after the embryo transfer
Method of measurement
The ratio of gestational sac determination on trans vaginal ultra Sonography to the number of transferred embryos.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:48 hours before embryo transfer (ET), 20 ml of peripheral venous blood will be obtained by syringe pre-filled with 2ml of Acid Citrate A anticoagulant solution(Royagen),and then will be centrifuged immediately at 170 g for 10 minutes to separate red blood cells.this plasma will be re_centrifuged at 340 g for 5 minutes to obtain platelet-rich plasma (PRP), that contained platelet 4-5 times more than peripheral blood. 0.5ml of PRP will be infused into the uterine cavity with IUI catheter and after 48 hours, ET will be done with IUI catheter(Takwin,Iran).
Category
Treatment - Other

2

Description
Control group: ET will be done with IUI catheter without intrauterine infusion of PRP.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Lak Parvaneh
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir
Web page address
http://shariati.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
TUMS Vice Chancellor for Research., Tehran University of Medical Sciences .,Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Parvaneh Lak
Position
Fellowship of infertility
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 2, Sohani Ave., Mohammadi far St., Ghaem Town., Artesh High way., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1955848979
Phone
+98 21 2249 8504
Fax
Email
lakparvaneh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvaneh Lak
Position
Fellowship of infertility
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 2, Sohani Ave., Mohammadi far St., Ghaem Town., Artesh High way., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1955848979
Phone
+98 21 2249 8504
Fax
Email
lakparvaneh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvaneh Lak
Position
Fellowship of infertility
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 2, Sohani Ave., Mohammadi far St., Ghaem Town., Artesh High way., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1955848979
Phone
+98 21 2249 8504
Fax
Email
lakparvaneh@yahoo.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
Loading...