Protocol summary

Study aim
Effect of platelet rich plasma (PRP) on live birth rate
Design
This double-blind, phase 2, randomized controlled clinical trial will perform in 50 patients with recurrent pregnancy loss and undergoing IVF treatment at Taleghani Hospital. Participants will be assigned to one of the control or intervention groups and each group will be 25 people.
Settings and conduct
This clinical trial will be performed in Infertility and IVF unit, Taleghani hospital. Fifty infertile patients with recurrent pregnancy loss will be recruited into study in two groups according to randomization method. Consent form will be taken from participants after awareness of them.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women under 40 years old, 30>BMI, and at least two previous pregnancy loss. exclusion criteria: Immunological or hematological disorders, Antiphospholipid antibody syndrome, hormonal or chromosomal abnormalities, and congenital or acquired uterus disorders.
Intervention groups
In intervention group, intrauterine administration of PRP will be performed 48 hours before embryo transfer. Autologous PRP will be prepared during a 2-step procedure. Prepared PRP (5 CC) will be inoculated into uterus. Hormonal therapy will continue until two weeks after embryo transfer.
Main outcome variables
Pregnancy and live birth rates

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160722029027N9
Registration date: 2019-12-04, 1398/09/13
Registration timing: retrospective

Last update: 2019-12-04, 1398/09/13
Update count: 0
Registration date
2019-12-04, 1398/09/13
Registrant information
Name
Leila Nazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
nazari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of platelet rich plasma (PRP) on improving pregnancy outcome in recurrent pregnancy loss patients a randomized clinical trial pilot study
Public title
Effect of platelet rich plasma (PRP) improving pregnancy outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women under 40 years 30>BMI At least two pregnancy loss
Exclusion criteria:
Immunologic disorder Anti phospholipid syndrome Hormonal disturbance Chromosomal disorder Congenital and acquired uterine disorder Hematological disturbance
Age
To 40 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by generating random numbers in Excel software. 1. In a column of Excel we enter 25 samples in each group. 2. In the next column we generate random numbers using the following command: RAND () 3. After sorting the generated random numbers, a random list will be generated according to which people will be assigned to two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blindness will be such that the patient will not know what treatment she will receive. Also, the researcher who records the results will not be aware of the type of treatment applied to the patient.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Yaman St, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2019-10-01, 1398/07/09
Ethics committee reference number
IR.SBMU.REC.1398.079

Health conditions studied

1

Description of health condition studied
Noninflammatory disorders of female genital tract
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Clinical pregnancy
Timepoint
5-7 weeks of gestation
Method of measurement
Ultrasonography

2

Description
Ongoing pregnancy
Timepoint
20 weeks of gestation
Method of measurement
Ultrasonography

3

Description
Live birth
Timepoint
9 months after embryo transfer
Method of measurement
Visualization

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Initiation of ovarian stimulation will start on day 3 of the menstrual cycle. Follicular monitoring will perform using serial ultrasonography. When the diameter of follicles reached approximately 14 mm, the GnRH antagonist will start. When at least three follicles >17 mm diameter visualizes in the ovaries, ovulation trigger will carry out using 10000 IU of human chorionic gonadotropin (hCG). The oocytes will aspirate from the ovaries 36 hours later. After intra-cytoplasmic sperm injection, intrauterine administration of platelet rich plasma (PRP) will be performed 48 hours before embryo transfer. Autologous PRP will be prepared during the 2-step procedure. Prepared PRP (5 CC) will be inoculated into the uterus. Finally, blastocyst embryos will transfer to the uterus.
Category
Treatment - Other

2

Description
Control group: Initiation of ovarian stimulation will start on day 3 of the menstrual cycle. Follicular monitoring will perform using serial ultrasonography. When the diameter of follicles reached approximately 14 mm, the GnRH antagonist will start. When at least three follicles >17 mm diameter visualizes in the ovaries, ovulation trigger will carry out using 10000 IU of human chorionic gonadotropin (hCG). The oocytes will aspirate from the ovaries 36 hours later. After intra-cytoplasmic sperm injection, blastocyst embryos will transfer to the uterus.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility and IVF unit of Talghani hospital
Full name of responsible person
Leila Nazari
Street address
Yaman St, Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 31 5533 4611
Email
nazari@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Nazari
Street address
Shahid Beheshti University of Medical Sciences, Yaman st., Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 2558
Email
nazari@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Teibeh Hashemi
Position
Fellowship of infertility
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shabih Khani Hospital .Shahid Beheshti St
City
Kashan
Province
Isfehan
Postal code
8714715555
Phone
+98 31 5546 0180
Email
hashemit89@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Nazari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani hospital, Yaman st., Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 2558
Email
nazari@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hashemi Teibeh
Position
Fellowship of infertility
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shabih Khani Hospital , Shahid beheshti St
City
Kashan
Province
Isfehan
Postal code
8714715555
Phone
+98 31 5546 0180
Email
hashemit89@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only information about the main outcome can be shared.
When the data will become available and for how long
Without restriction
To whom data/document is available
All researchers
Under which criteria data/document could be used
With permission from the responsible author
From where data/document is obtainable
Email to the responsible author
What processes are involved for a request to access data/document
Email to the responsible author
Comments
Loading...