Effects of Autologus Platelet- Rich Plasma on ICSI outcomes and Pregnancy Rate in frozen embryo transfer cycles in Repeated Implantation Failure Patients
After injection of a GnRH agonist in previous cycle, tablet of estradiol valerate 2 mg will be started since the third day of menstrual cycle and be increased to 8 mg. When endometrial line becomes triple and its thickness reaches to 7.5 or more (till 12 mm) , the embryos will be transferred. PRP will be done for patents 48 hours before embryo transfer. For PRP, 8.5 cc of peripheral blood was given and the number of platelets was calculated. After 2 times centrifuge, the number of platelets was checked again and if it becomes 4 to 5 times, 0.5 cc of this solution was injected into uterus by embryo transfer catheter. The embryo transfer catheter will be inserted and removed without injection of anything in control group. The serum level of B-hcG will be checked 2 weeks after embryo transfer and positive tests will be mentioned as success implantation. Trans vaginal sonography will be done 3 weeks later for detecting embryo sac and fetal heart rate which considered as clinical pregnancy.
General information
Acronym
PRP in RIF in FET cycles
IRCT registration information
IRCT registration number:IRCT2017073034422N2
Registration date:2017-10-16, 1396/07/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-16, 1396/07/24
Registrant information
Name
Sheyda Jouhari
Name of organization / entity
Avicenna Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0815
Email address
s.jouhari@ari.ir
Recruitment status
Recruitment complete
Funding source
Avicenna Research Institute
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Autologus Platelet- Rich Plasma on ICSI outcomes and Pregnancy Rate in frozen embryo transfer cycles in Repeated Implantation Failure Patients
Public title
Effects of Autologus Platelet- Rich Plasma on ICSI outcomes and Pregnancy Rate in frozen embryo transfer cycles in Repeated Implantation Failure Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient who has at least 2 cycle IVF failure; At least 6 good quality embryos were transferred in previous cycles; Semen count≥10 millions,normal morphology ≥3% in semen analysis
Exclusion criteria:
1-patient without immunologic disorders (abnormality in CD markers, Anti TG, Anti TPO, ds DNA, ANA); hematologic disorder; genetic diseases; uterus disorders; Hb<11 mg/dl and Platelet<150000/mm3; use of corticosteroid during 14 days before of PRP
Age
From 20 years old to 41 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Avicenna Research Institute
Street address
Avicenna Research Institute; Shahid Beheshti University; Velenjak; Tehran
City
Tehran
Postal code
19615-1177
Approval date
2017-05-02, 1396/02/12
Ethics committee reference number
IR.ACECR.Avicenna.REC.1396.9
Health conditions studied
1
Description of health condition studied
Infertility, recurrent implantation failure
ICD-10 code
98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Chemical pregnancy rate
Timepoint
Two weeks after intervention
Method of measurement
Beta HCG in blood
Secondary outcomes
1
Description
Implantation Rate
Timepoint
Six weeks after intervention
Method of measurement
Calculation (number of embryos transfer /number of pregnancy sacs in sonography 6 weeks after ET)
Intervention groups
1
Description
In intervention group, PRP will be done for patient 48 hours before embryo transfer. For PRP, 8.5 cc of peripheral blood will be given and the number of platelet will be checked. Then the blood will be put in a space which
has 2.5 cc special anti coagulant and centrifuged with 1200 rpm for 12 minutes. Then superior part of plasma will be separated and centrifuged with 3500 rpm for 6 minutes again. The platelet number will be checked again and if it becomes 4-5 times, 0.5 cc of this solution will be transferred into uterus cavity 48 hours before embryo transfer.
Category
Treatment - Other
2
Description
In control group, the embryo transfer catheter will be inserted for patient 48 hours before embryo transfer and will be removed without injection of anything.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Avicenna infertility clinic
Full name of responsible person
Sheyda Jouhari
Street address
No 97, Yakhchal st., Shariati st.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Avicenna Research Institute
Full name of responsible person
Dr. Seyed Ali Azin
Street address
Avicenna Research Institute; Shahid Beheshti University; Velenjak; Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Avicenna Research Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Avicenna Infertility Clinic
Full name of responsible person
Sheyda Jouhari
Position
MD/ Infertility fellowship
Other areas of specialty/work
Street address
No.97, Yakhchal St., Shariati St.
City
Tehran
Postal code
19615-1177
Phone
+98 21 23519
Fax
+98 21 2264 4754
Email
s.jouhari@ari.ir
info@avic.ir
Web page address
www.avic.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Avicenna Infertility Clinic
Full name of responsible person
Sheyda Jouhari
Position
MD/ Infertility fellowship
Other areas of specialty/work
Street address
No.97, Yyakhchal st. Shariati st.
City
Tehran
Postal code
19615-1177
Phone
+98 21 23519
Fax
+98 21 2264 4754
Email
s.jouhari@ari.ir
info@avic.ir
Web page address
www.avic.ir
Person responsible for updating data
Contact
Name of organization / entity
Avicenna Infertility Clinic
Full name of responsible person
Sheyda Jouhari
Position
MD/ Infertility fellowship
Other areas of specialty/work
Street address
No.97, Yakhchal st., Shariati st.
City
Tehran
Postal code
19615-1177
Phone
+98 21 23519
Fax
+98 21 2264 4754
Email
s.jouhari@ari.ir
info@avic.ir
Web page address
www.avic.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)