comparisson of the effectivness of intrauterine infusion of platelet-rich plasma versus no intervention on pregnancy rates in infertile women with repeated implantation failure
Determination the effect of platelet-rich plasma on pregnancy rates in infertile women with repeated implantation failure.
Design
Randomized, not blind, double center, phase 2.
Settings and conduct
Ninety infertile women with repeated implantation failure who attending in infertility department in Imam khomaini Hospital, Mazandaran University of Medical Sciences, Sari, Iran, divided in two groups based on random numbers table. Patients and physician became aware and informed from intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 20 to 40 years, uterine tubal patency, prior three or more failed in vitro fertilization cycles. Exclusion criteria: Body mass index over the 30 kilogram per meter square, hematologic, immunologic, hormonal, genetic and renal disorders.
Intervention groups
Intervention 1: Intrauterine infusion of platelet-rich plasma 48 hours before embryo transfer.
Intervention 2: Freeze embryo transfer.
Main outcome variables
Clinical pregnancy rate
General information
Reason for update
Acronym
PRP
IRCT registration information
IRCT registration number:IRCT20160815029374N2
Registration date:2018-01-16, 1396/10/26
Registration timing:registered_while_recruiting
Last update:2018-01-16, 1396/10/26
Update count:0
Registration date
2018-01-16, 1396/10/26
Registrant information
Name
Marzieh Zamaniyan
Name of organization / entity
Mazandaran University of Medical Sciences, Sari, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 5724
Email address
m.zamanian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-05-21, 1397/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparisson of the effectivness of intrauterine infusion of platelet-rich plasma versus no intervention on pregnancy rates in infertile women with repeated implantation failure
Public title
Effect of PRP on pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 20-40 year
Body mass index lower than 30 Kilogram per square meter
Normal husterosalpingography
At least prior three failed in vitro fertilization failure
Randomization is done based on the random number table on the day of progesterone initiation in freeze embryo transfer cycle by one nurse. In fact, only the nurse knows which patient is under the PRP infusion, or not. Physicians do not know which patient is undergoing PRP, but patients know about the intervention due to informed consent,therefore, it is not possible to concealed the patients in this group.
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 Mazandaran University of Medical Sciences
Street address
No. 5, third floor, Cancer ward, Imam Khomeini Hospital, Amir Mazandarani Ave, Diabetes Research Center.
City
Sari
Province
Mazandaran
Postal code
3313148166
Approval date
2017-05-27, 1396/03/06
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.96.2911
Health conditions studied
1
Description of health condition studied
Diseases of the genitourinary system
ICD-10 code
N97; N98
ICD-10 code description
Female infertility; Complications associated with artificial fertilization
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
Forth weeks after embryo transfer
Method of measurement
Questionnare
Secondary outcomes
1
Description
Miscarriage rates
Timepoint
Till twenty weeks after embryo transfer
Method of measurement
Questionnare
2
Description
Implantation rate
Timepoint
Forth weeks after embryo transfer
Method of measurement
Questionare
Intervention groups
1
Description
Intervention group: Intrauterine infusion of 0.5 CC of autologus platelet-rich plasma (has 4-6 times platelet concentration rather than peripheral blood by IUI catheter(Takvin company, Iran) 48 hours before freeze embryo transfer.
Category
Treatment - Other
2
Description
Control group: Transfer of three Freeze embryos by chateter ( Cook, USA) under ultrasonographic guidance.