Comparison of the effect of intraovarian injection of Plasma Rich Growth Factor (PRGF) and Plasma Rich Platelate (PRP) on improving the response and pregnancy outcomes in women undergoing IVF with poor ovarian response
The effect of intraovarian injection of plasma rich growth factor(PRGF) on improving the response and pregnancy outcomes in women undergoing IVF with poor ovarian response
Design
The clinical trial consisted of prp intraovarian injection sample group and prgf control group, double-blind, randomized, phase 2 on 30 patients. Excel software rand function was used for randomization.
Settings and conduct
Ovarian stimulation will be done on day 3 of the menstrual cycle. When the follicles are about 14 mm in diameter, the GnRH antagonist begins. When at least three follicles more than 17 mm in diameter are observed in the ovaries, ovulation induction will be performed using 10,000 IU of human chorionic gonadotropin (hCG).The eggs will be aspirated 36 hours after hCG administration. On the day of ovulation after an ovarian puncture, 3 cc of PRGF/PRP will be injected into each ovary. In the third menstrual cycle after checking the serum levels of FSH, AMH, patients will be undertaken again the ovulation stimulation cycle. Finally, outcom of pregnancies will be assessed in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women under 42 years of age with a history of low ovarian reserve (less than 3 eggs in previous IVF cycle or abnormal laboratory tests)
Exclusion criteria: Women with anemia, history of malignancy, any endocrine disorders (hypothyroidism, hyperprolactinemia)
Intervention groups
In the intervention group, 3 cc of PRGF is injected during ovulation and in the control group, 3 cc of PRP is injected during ovulation.
Main outcome variables
clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160722029027N12
Registration date:2022-05-14, 1401/02/24
Registration timing:registered_while_recruiting
Last update:2022-05-14, 1401/02/24
Update count:0
Registration date
2022-05-14, 1401/02/24
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
2022-05-10, 1401/02/20
Expected recruitment end date
2022-12-11, 1401/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intraovarian injection of Plasma Rich Growth Factor (PRGF) and Plasma Rich Platelate (PRP) on improving the response and pregnancy outcomes in women undergoing IVF with poor ovarian response
Public title
Comparison of the effect of intraovarian injection of PRGF and PRP on improving the response and pregnancy outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women under the age of 42
Having a history of low ovarian reserve (less than 3 eggs in the previous IVF cycle)
Abnormal laboratory tests anti mulerian hormone fewer than 1.1ng /dl
Counting antral follicles 5-7 on transvaginal sonography
Exclusion criteria:
Women with anemia diagnosis
history of malignancy
Any endocrine disorders (hypothyroidism, hyperprolactinemia)
Age
To 42 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
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)
Single 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
Not 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
2022-03-06, 1400/12/15
Ethics committee reference number
IR.SBMU.REC.1400.026
Health conditions studied
1
Description of health condition studied
patient with diminished ovarian reserve
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The rate of clinical pregnancy in the two groups undergoing PRGF and the PRP
Timepoint
4 week after embryo transfer
Method of measurement
By seeing the fetal heartbeat on ultrasound
Secondary outcomes
1
Description
The number of retrieved oocytes in the two groups injected with PRGF and PRP
Timepoint
During ovarian puncture
Method of measurement
counting
Intervention groups
1
Description
In the intervention group, 1:35 cc of blood is taken from women. The blood sample is centrifuged at 1200 rpm for 12 minutes to separate the red blood cells. The extracted plasma is centrifuged at 3500 rpm for 7 minutes. Three cc of plasma remains in each tube, which is injected into the ovary through the vagina within 20 minutes after preparation for injection with a special ovulation needle.
Category
Treatment - Surgery
2
Description
In intervention group 2: first,1.5 cc of platelet activating factor made by the company (Aria based on diagnosis) will be added to 3 cc of platelet-rich plasma and after 20 minutes, two phases will be created in plasma preparation. A portion of platelet debris will be formed at the top and a portion of growth factor-rich plasma at the bottom. In the last step, it will be centrifuged for 4 minutes at 4000 rpm. The supernatant is then drawn with a needle and the sample will be taken with an ovulation needle through the ovary
Category
Treatment - Surgery
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
Afshin Zarghi
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
Zarghi@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
Zahra Razghandi
Position
Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Velenjak,Yaman St, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 2560
Email
z.razghandi@gmail.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
Infertility Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Velenjak, Yaman St, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
021230311
Email
leynaz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Razghandi
Position
Medical doctor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Velenjak, Yaman St, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 2560
Email
z.razghandi@gmail.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, including chemical pregnancy, clinical pregnancy, ongoing pregnancy, abortion rate, and possible complications from the intervention, 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 authorEmail to 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