Evaluation of the application platelet rich plasma in the treatment of patients with recurrent implantation failure in IVF-ICSI & freeze embryo transfer cycles
Comparison of live births rate in embryo transfer cycles with and without intra uterine infusion of platelet rich plasma (PRP) in patients with recurrent implantation failure.
Design
A randomized clinical trial with control group, open label, two arm parallel group design of 40 patients. Randomization is performed using a computer-generated random assignment schedule for each patient. Sealed and numbered envelopes are used to conceal the treatment allocation until randomization.
Settings and conduct
Female infertility Clinic of ROYAN institute.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Infertile women with a history of recurrent implantation failure; Age 20-40 years; Body Mass Index 19-29 Kg/m2; Having at least three good quality embryo.
Exclusion criteria: Women with hematologic and autoimmune disorders; Couples with chromosomal and genetic abnormalities; Women with uterine anomalies; Women with uterine and ovaries surgical history; Women with endometriosis and adenomyosis; Women with hydrosalpinx; Women with uterine fibroids; Women with recurrent abortion history; Cervicitis; History of fever condition; Use of corticosteroids or non-steroid anti-inflammatories; Anemia, thrombocytopenia, platelet dysfunction syndrome, hypofibrinogenemia; Septicemia, active infections with Pseudomonas, Klebsiella or Enterococcus; History of cancer.
Intervention groups
1. The group of embryo transfer with intrauterine infusion of PRP. One milliliter of PRP will be injected into the patients’ uterine cavity using an embryo transfer catheter, 48 hours before embryo transfer.
2. The group of embryo transfer without intrauterine infusion of PRP. In order to eliminate the effects of catheter insertion, the same catheter will be applied to the patients’ uterine cavity without any injections, 48 hours before the embryo transfer.
Main outcome variables
Live births rate
General information
Reason for update
Acronym
PRP-RIF
IRCT registration information
IRCT registration number:IRCT20080831001141N37
Registration date:2021-01-06, 1399/10/17
Registration timing:registered_while_recruiting
Last update:2021-01-06, 1399/10/17
Update count:0
Registration date
2021-01-06, 1399/10/17
Registrant information
Name
Kiandokht Kiani
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 7960
Email address
kiandokht.kiani@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the application platelet rich plasma in the treatment of patients with recurrent implantation failure in IVF-ICSI & freeze embryo transfer cycles
Public title
Platelet rich plasma and recurrent implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with a history of recurrent implantation failure
Age 20-40 years
Body Mass Index 19-29 Kg/m2
Having at least three good quality embryos
Exclusion criteria:
Women with hematologic and autoimmune disorders
Couples with chromosomal and genetic abnormalities
Women with uterine anomalies
Women with uterine and ovaries surgical history
Women with endometriosis and adenomyosis
Women with hydrosalpinx
Women with uterine fibroids
Women with recurrent abortion history
Cervicitis
History of fever condition (in up to 2 weeks before the intervention)
Use of corticosteroids (in up to 2 weeks before the intervention) or non-steroid anti-inflammatories (in up to 48 hours before the intervention)
Anemia, thrombocytopenia, platelet dysfunction syndrome, hypofibrinogenemia
Septicemia, active infections with Pseudomonas, Klebsiella or Enterococcus
History of cancer
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method is designed by epidemiologist using STATA software version 13 and the number of blocks considered is 8. The random allocation list for patients is solely available to the epidemiologist. In order to hide the random allocation process, a total of 40 envelopes are prepared, and only the methodologist has been aware of table of random numbers. When the doctor declared the patient's eligibility, the methodologist provided the doctor with the envelope. The group will be selected and based on the type of group mentioned in the envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
مرکز ثبت کارآزمایی های بالينی ايالات متحده آمريکا (WWW.clinicaltrial.gov)
Secondary trial Id
NCT03996837
Registration date
2019-06-25, 1398/04/04
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Royan Institute
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Approval date
2017-08-15, 1396/05/24
Ethics committee reference number
IR.ACECR.ROYAN.REC.1396.99
Health conditions studied
1
Description of health condition studied
recurrent implantation failure
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Live birth rate; live birth is defined in which a live fetus is delivered beyond 20 completed weeks of gestational.
Timepoint
Only once; at least 20 weeks after embryo transfer.
Method of measurement
Clinical information.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group of embryo transfer (fresh and or freeze) with intra uterine infusion of platelet rich plasma (PRP). In in vitro fertilization cycles, ovarian stimulation will be performed through the standard protocol using gonadotropin-releasing hormone (GnRH) agonist. In freeze embryo transfer cycles, the endometrial preparation will be performed through the standard protocol using GnRH agonist. One milliliter of PRP will be injected into the patients’ uterine cavity using an embryo transfer catheter, 48 hours before embryo transfer.
Category
Treatment - Other
2
Description
Control group: The group of embryo transfer (fresh and or freeze) without intra uterine infusion of PRP. In in vitro fertilization cycles, ovarian stimulation will be performed through the standard protocol using GnRH agonist. In freeze embryo transfer cycles, the endometrial preparation will be performed through the standard protocol using GnRH agonist. In order to eliminate the effects of catheter insertion, the same catheter will be applied to the patients’ uterine cavity without any injections, 48 hours before the embryo transfer.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center of ROYAN
Full name of responsible person
Mehri Mashayekhy
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2647
Fax
+98 21 2230 6481
Email
dr.mashayekhy@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ROYAN Institute
Full name of responsible person
Parvaneh Afsharian
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2674
Fax
+98 21 2230 6481
Email
pafshar@royaninstitute.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
ROOYAGEN company
Proportion provided by this source
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
ROYAN Institute
Full name of responsible person
Mehri Mashayekhy
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2647
Fax
+98 21 2230 6481
Email
dr.mashayekhy@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
ROYAN Institute
Full name of responsible person
Mehri Mashayekhy
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2647
Fax
+98 21 2230 6481
Email
dr.mashayekhy@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
ROYAN Institute
Full name of responsible person
Mehri Mashayekhy
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2647
Fax
+98 21 2230 6481
Email
dr.mashayekhy@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Clinical study report (published article)
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Available to the public.
Under which criteria data/document could be used
Scientific use by citing the source.
From where data/document is obtainable
Dr. Mehri Mashayekhy
Email: dr.mashayekhy@yahoo.com
What processes are involved for a request to access data/document