A comparative study of the effect of platelet-rich plasma (PRP) and granulocyte colony-stimulating factor (GCSF) in patients with recurrent implantation failure
Comparison of the effect of PRP and G CSF in the treatment of infertility
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
This study will be conducted in the infertility department of Beheshti Hospital in Isfahan in 1401. A number of 50 patients are selected based on the inclusion and exclusion criteria and divided randomely into two intervention groups with PRP and GCSF after using a random number table. In this study, the researcher and the participants and analyser are blinded. In the group receiving PRP, 2.5 cc of PRP obtained from the patient's own blood is injected into the uterus. In the group receiving GCSF, they will receive 300 micrograms of subcutaneous GCSF one hour before transfergenin. Finally, the rate of positive pregnancy test (chemical pregnancy), implantation rate (clinical pregnancy) and pregnancy reaching 12 weeks (ongoing) pregnancy (in these two groups are compared).
Participants/Inclusion and exclusion criteria
inclusion criteria
Age 20 to 45 years,
Patients with recurrent implantation failure (RIF),
Patients with a maximum of 10 unsuccessful transfers of embryos,
informed consent,
exclusion criteria:
Hematological disorders (leukemia, thrombocytopenia), immunological disorders (antiphospholipid syndrome, thrombophilia), hormonal disorders (diabetes, thyroid, hyperprolactinemia), chromosomal and genetic abnormalities (hereditary or congenital), and kidney failure
Intervention groups
two groups. The group treated with platelet rich plasma and the group treated with Granulocyte colony-stimulating factor
A comparative study of the effect of platelet-rich plasma (PRP) and granulocyte colony-stimulating factor (GCSF) in patients with recurrent implantation failure
Public title
Investigating the effect of PRP and GCSF on infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
at least 3 and at most 10 implantation failure
The possibility of receiving enough platelets
informed consent
age criteria 20to 45
Randomization in this study will be done in a simple and individual way. In this method, with the help of a random number table, each participant will be assigned a number. Then, based on the size of the research sample, a number of envelopes with aluminum wrapping (in view of the lack of clarity of the contents of the envelopes), preparation and each of the random sequences created on a card are recorded and the cards are placed inside the envelopes in order. In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box in order. At the time of registration of the participants, according to the order of entry of the eligible participants into the study, one of the letter envelopes will be opened and the assigned group of that participant will be revealed in such a way that if the random sequence is even, he will enter the first group and if If the sequence is odd, they will enter the second 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 Esfahan University of Medical Sciences
Street address
No84, lale dead end, parvaresh alley , kharazi street
City
Esfahan
Province
Isfehan
Postal code
8187645654
Approval date
2022-08-11, 1401/05/20
Ethics committee reference number
IR.MUI.MED.REC.1401.191
Health conditions studied
1
Description of health condition studied
recurrent implantation failure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pregnancy
Timepoint
12weeks
Method of measurement
A positive answer for each of the factors alone: seeing the pregnancy sac or seeing the fetal heart in ultrasound or positive chemical pregnancy test.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 GCSF subcutaneous injection of 300 micrograms once
Category
Treatment - Drugs
2
Description
Intervention group 2 PRP injection in the amount of 2.5 cc once intrauterine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
Elnaz mostajeran
Street address
No84,lLe dead end,parvaresh alley,kharazi street
City
Esfahan
Province
Isfehan
Postal code
8187645654
Phone
+98 31 3336 8908
Email
Elnaz.mostajeran88@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elnaz mostajeran
Street address
No84,lale dead end,parvaresh alley,kharazi street
City
اصفهان
Province
Isfehan
Postal code
8187645654
Phone
+98 31 3336 8908
Email
Elnaz.mostajeran88@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Elnaz mostajeran
Position
Medical doctor, Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No84,lale dead end,parvaresh alley,kharazi street
City
Esfahan
Province
Isfehan
Postal code
8187645654
Phone
+98 31 3336 8908
Email
Elnaz.mostajeran88@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elnaz mostajeran
Position
Medical doctor,resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No84,lale dead end, parvaresh alley, kharazi street
City
Esfahan
Province
Isfehan
Postal code
8187645654
Phone
+98 31 3336 8908
Email
Elnaz.mostajeran88@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elnaz Mostajeran
Position
Resident,Medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No84,lale dead end ,parvaresh alley,kharazi street
City
Esfahan
Province
Isfehan
Postal code
8187645654
Phone
+98 31 3336 8908
Email
Elnaz.mostajeran88@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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