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?