Evaluation of intrauterine Platelet Rich Plasma injection on pregnancy rate in women with implantation failure In Vitro Fertilization fertilization cycle
Evaluation of intrauterine Platelet Rich Plasma injection on pregnancy rate in women with implantation failure In Vitro Fertilization fertilization cycle
Design
A clinical trial with two groups of control and intervention, with parallel groups, without blinding, randomized by block method
Settings and conduct
Block randomized clinical trial on 90 infertile women with a history of implantation failure who are candidates for fetal embryo transfer, Zahedan Infertility Clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria: no underlying disease, 20 <age <40 years with 2 or 3 times implantation failure;
Non-inclusion criteria: uterine anomaly, specific drug use
Intervention groups
intervention group: All patients will receive 6 mg/d Estradiol valerate from the second day of the menstrual cycle until the endometrial thickness reaches 8 mm, 400 mg progesterone vaginal suppository BD will be initiated. Three days later, 2-3 high-quality 8-cell embryos (day 3) will be transferred. Intrauterine infusion of concentrated platelet will be performed 48 hours before embryo transfer. Estradiol valerate and progesterone suppository will be continued after embryo transfer for two weeks. In the case of any kind of pregnancy and positive B-HCG, hormone replacement therapy will be continued until 12 weeks of pregnancy. Two embryos will be transferred for patients under 35 and three embryos for patients above 35. 0.5 ml of the concentrated platelet will be infused to the interior of the uterus wall using an IUI catheter. Pregnancy will be diagnosed with a B-HCG test and transvaginal ultrasound.
Control group: All the procedures in the intervention group except intrauterine injection of plasma concentrate were performed in the control group.
Main outcome variables
The number of pregnancies
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180425039418N9
Registration date:2019-11-09, 1398/08/18
Registration timing:retrospective
Last update:2019-11-09, 1398/08/18
Update count:0
Registration date
2019-11-09, 1398/08/18
Registrant information
Name
mohammad Ghena'at Pisheh Sanani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3343 1227
Email address
mohammad.ghenaat71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of intrauterine Platelet Rich Plasma injection on pregnancy rate in women with implantation failure In Vitro Fertilization fertilization cycle
Public title
The effect of intrauterine injection of plasma concentrated platelet on pregnancy rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not the Underlying Disease
being at the Age of 20 to 40
2 or 3 times implantation failure history
Exclusion criteria:
Specific drug use
Low quality embryos
Endometrial growth not more than 8 mm
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:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Convenient sampling method will be used and blocked randomization (using a random number table) will be used for patient allocation to 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 Zahedan University of Medical Sciences
Street address
Dr.Hesabi Square, Campus of Medical Scineces
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-03-10, 1397/12/19
Ethics committee reference number
IR.ZAUMS.REC.1397.486
Health conditions studied
1
Description of health condition studied
implantation failure
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
The number of pregnancies
Timepoint
Chemical and clinical pregnancy are respectively defined as positive serum level of B-hCG two weeks after embryo transfer, and fetal heart beat in trans-vaginal sonography five weeks after embryo transfer.
Method of measurement
The structured checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All patients will receive 6 mg/d Estradiol valerate from the second day of the menstrual cycle until the endometrial thickness reaches 8 mm. When the endometrial thickness reached 8 mm, 400 mg progesterone vaginal suppository BD will be initiated. Three days later, 2-3 high quality (grade A or B) 8-cell embryos (day 3) will be transferred. In the case group, intrauterine infusion of concentrated platelet will be performed 48 hours before embryo transfer. Concentrated platelet-derived from autologous blood will be centrifuged in two steps. Estradiol valerate and progesterone suppository will be continued after embryo transfer for two weeks. In the case of any kind of pregnancy and positive B-hCG, hormone replacement therapy will be continued until 12 weeks of pregnancy. All embryos will be transferred by infertility fellowship under the sonography guide. Two embryos will be transferred for patients under 35 and three embryos for patients above 35. On the day of consecrated platelet infusion, 17.5 ml of venous blood will be taken in a syringe containing 2.5 ml of citric acid (anti-coagulation solution) which will be immediately centrifuged at 1200 rpm for 12 minutes to separate blood cells. Then, plasma is centrifuged at 3300 rpm for 7 minutes to achieve concentrated platelet which contains 4-5 times more platelet compared with venous blood. 0.5 ml of the concentrated platelet will be infused to the interior of the uterus wall using an IUI catheter (Takvin, made in Iran). The period before infusion will be considered as the control for each case. Chemical and clinical pregnancy are respectively defined as a positive serum level of B-hCG two weeks after embryo transfer, and fetal heartbeat in transvaginal sonography five weeks after embryo transfer.
Category
Treatment - Other
2
Description
Control group: All patients will receive 6 mg/d Estradiol valerate from the second day of the menstrual cycle until the endometrial thickness reaches 8 mm. When the endometrial thickness reached 8 mm, 400 mg progesterone vaginal suppository BD will be initiated. Three days later, 2-3 high quality (grade A or B) 8-cell embryos (day 3) will be transferred. Estradiol valerate and progesterone suppository will be continued after embryo transfer for two weeks. In the case of any kind of pregnancy and positive B-hCG, hormone replacement therapy will be continued until 12 weeks of pregnancy. All embryos will be transferred by infertility fellowship under the sonography guide. Two embryos will be transferred for patients under 35 and three embryos for patients above 35. Chemical and clinical pregnancy are respectively defined as a positive serum level of B-hCG two weeks after embryo transfer, and fetal heartbeat in trans-vaginal sonography five weeks after embryo transfer.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Moulood Infertility Clinic- Zahedan University of Medical Sciences
Full name of responsible person
Marzieh Ghasemi
Street address
Dr.Hesabi Square, Campus of Medical Scineces
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
public@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Noormohammad Bakhshani
Street address
Dr.Hesabi Square, Campus of Medical Scineces
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research, Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Sara Ershadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Dr.Hesabi Square , campus of medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43175
Phone
+98 54 3329 5620
Email
sara_e1990@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Marzieh Ghasemi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Dr. Hesabi square campus of medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43175
Phone
+98 543329571522
Email
public@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Ghena'at Pisheh Sanani
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Velayat 1 Alley,Nasr Street,Zibashahr,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817978761
Phone
+98 54 3343 1227
Fax
Email
mohammad.ghenaat71@gmail.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
No - There is not 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