evaluation of the effects of intra-ovarian injection of autologous platelate rich plasma (PRP) to ovarian reserve in poor responders
Design
This is a before and after trial that will be performed on 22 infertile women who have laboratory and ultrasound criteria predicting a poor response to ovarian stimulation. Participants will be stimulated by an antagonist protocol, after oocyte pick up 2 cc of PRP, will be injected into the cortex of each ovaries. Two months later, they will undergo another ovarian stimulation cycle with the same protocol. The number of antral follicular count, AMH, day 2-3 FSH, LH, FSH/LH, the trigger day estradiol level, the number of oocytes obtained will be compared between the two cycles.
Settings and conduct
The present study is a before and after clinical trial. After confirmation of the ethics committee, sampling will begone in the easy and accessible manner, so that the researcher in the infertility clinic of Alzahra hospital after introducing herself, explains the steps of conducting research and obtains informed, written and signed consent from interested patients.
Participants/Inclusion and exclusion criteria
inclusion criteria: AMH less than 1.1; number of antral follicles less than 5-7; history of cycle cancellation due to insufficient follicular growth; history of cycle cancellation due to less than 3 oocytes obtained; willingness to cooperate;
exclusion criteria: IGA deficiency; genital or non-genital cancers; treatment with anticoagulants; ovarian failure due to chromosomal abnormality; severe pelvic adhesion; non-acceptance or cooperation of the patient
Intervention groups
On the day of ovulation, after the puncture, two cc of PRP
is injected into each ovary in the same session.
Main outcome variables
Number of oocytes obtained; day 2-3 FSH and LH ; AMH; serum estradiol levels on the triggering day
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101227005485N9
Registration date:2021-01-22, 1399/11/03
Registration timing:registered_while_recruiting
Last update:2021-01-22, 1399/11/03
Update count:0
Registration date
2021-01-22, 1399/11/03
Registrant information
Name
Nazli Navali
Name of organization / entity
Tabriz University of Medical Sciences, Faculty of Medecine
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 2879
Email address
navalin@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effects of intra-ovarian injection of autologous platelet rich plasma to ovarian reserve in poor responders
Public title
effects of intra-ovarian injection of autologous platelet rich plasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Antimullerian hormone(AMH) less than 1.1
number of antral follicles less than 5-7
history of cycle cancellation due to insufficient follicular growth
history of cycle cancellation due to less than 3 oocytes obtained
willingness to cooperate
Ages between 30 and 43 years
Exclusion criteria:
Immunoglobulin A deficiency
genital or non-genital cancers
treatment with anticoagulants
ovarian failure due to chromosomal abnormality
severe pelvic adhesion
non-acceptance or cooperation of the patient
Age
From 30 years old to 43 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
More than 1 sample in each individual
Number of samples in each individual:
2
Before and after injection of platelet-rich plasma
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical
Street address
Research Deputy of Tabriz University of Medical Sciences, University of Tabriz, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-11-09, 1399/08/19
Ethics committee reference number
IR.TBZMED.REC.1399.794
Health conditions studied
1
Description of health condition studied
diminished ovarian reserve
ICD-10 code
N97.0
ICD-10 code description
infertility due to diminished ovarian reserve
Primary outcomes
1
Description
Number of oocytes obtained
Timepoint
Immediately after ovarian puncture before and 2 months after injection of platelet-rich plasma (PRP)
Method of measurement
Under a microscope by an embryologist
2
Description
Follicular Stimulating Hormone (FSH) and Luteinizing Hormone (LH) day two or three of menstruation
Timepoint
Cycle before and 2 months after injection of platelet-rich plasma
Method of measurement
electrochemiluminescence
3
Description
antimulerian hormone
Timepoint
Cycle before and 2 months after injection of platelet-rich plasma
Method of measurement
electrochemiluminescence
4
Description
Comparison of serum estradiol levels on the day of ovulation triggering
Timepoint
Cycle before and 2 months after injection of platelet-rich plasma
Method of measurement
electrochemiluminescence
Secondary outcomes
1
Description
Number of 4 to 8 cells embryos
Timepoint
2 to 3 days
Method of measurement
With a microscope by an embryologist
Intervention groups
1
Description
Intervention group: Immediately after second ovarian puncture, intra-ovarian injection of 2 millilitre of platelet-rich plasma into each ovary will be done. Platelet-rich plasma is taken from the individual's own peripheral blood and centrifuged twice, using standard Ryagen kits approved by the US Food and Drug Administration.
Category
Treatment - Surgery
2
Description
Control group: they are the same participents before any intervention is done, ie intra-ovarian injection will not be performed after the first ovarian puncture.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital Infertility Ward
Full name of responsible person
Dr. Navali Nazli
Street address
South Artesh Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
navalin@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Laya Farzadi
Street address
South Artesh Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
navalin@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Nazli Navali
Position
infertility fellowship/associate professor
Latest degree
Subspecialist
Other areas of specialty/work
infertility fellowship/associate professor
Street address
Alzahra hospital, Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
navalin@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nazli Navali
Position
associate professor/infertility fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Artesh street, Alzahra Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
navalin@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nazli Navali
Position
associate professor/infertility fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alzahra Hospital, Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
navalin@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It may not be used properly.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available