Investigating the effect of intraovarian administration of platelet rich plasma in patients with poor ovarian response in improving the result of assisted procedures
Determination of the effect of intraovarian administration of platelet-rich plasma in patients with poor ovarian response following the use of assisted reproductive methods
Design
In a clinical trial study with a control group, with parallel groups, with blinding, randomized, phase 3, on 88 infertile women with reduced ovarian reserve, they are randomly placed in one of the two groups of intraovarian injection of PRP and control. Randomization is done using the Random between function software of the Excel program.
Settings and conduct
This work is done in Bandar Abbas infertility center on 2 groups of infertile women with reduced ovarian reserve.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Informed consent of the patient
• Patients aged 18 to 45 years
• Normal sperm test
• POR
Exclusion criteria:
• Unwillingness to continue cooperation
• Abnormal sperm test
• Patients under 18 years old and over 45 years old
Intervention groups
People are randomly assigned to one of the two groups of PRP intraovarian injection and the control group (without PRP injection).
Main outcome variables
The number of retrieved oocytes, the number of retrieved metaphase two oocytes, the serum level of AMH hormone two months after the intervention, the clinical pregnancy rate, the ongoing pregnancy rate, the live birth rate, the number of canceled IVF cycles.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200905048630N5
Registration date:2023-09-22, 1402/06/31
Registration timing:prospective
Last update:2023-09-22, 1402/06/31
Update count:0
Registration date
2023-09-22, 1402/06/31
Registrant information
Name
Ensieh Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 0755
Email address
salehiensieh@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of intraovarian administration of platelet rich plasma in patients with poor ovarian response in improving the result of assisted procedures
Public title
Investigating the effect of intraovarian administration of platelet rich plasma in patients with poor ovarian response in improving the result of assisted procedures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent of the patient (completion of the patient consent form by the patient or the patient's companion)
Patients aged 18 to 45 years.
Patients who have no history of ovarian surgery or ovarian endometrioma.
Normal sperm analysis
• POR (age over 40 years and/or a history of poor response to high-dose stimulation with less than three oocytes and/or adverse ovarian reserve tests including AMH < 1.1 ng/nl; AFC < 7)
Patients without endocrine disorders such as hyperprolactinemia, PCOS, etc.
Non-smoking patients
Patients who do not have cardiovascular disorders.
Exclusion criteria:
Adhesion or severe damage to the pelvis or ovaries
Immunological diseases
Hematological diseases
Platelets less than one hundred and fifty thousand per cubic millimeter
Systemic use of corticosteroids within two weeks before the procedure
Taking anticoagulants
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients (including 88 patients) are randomly assigned by a statistical expert using simple randomization method. In this method, the Random between function of the Excel program is used to generate a random number between the number 1 and 2. This work was repeated 88 times and thus a random sequence is obtained.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst will not know about the allocation of groups and the type of intervention performed, and the data will be provided to the analyst in the form of two groups A and B (without mentioning the names of the control group and the intervention group).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Hormozgan University of medical sciences
Street address
Deputy of research and technology, campus of Hormozgan University of Medical Sciences, Imam Hossein boulevard, Bandar Abas, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Approval date
2023-09-17, 1402/06/26
Ethics committee reference number
IR.HUMS.REC.1402.279
Health conditions studied
1
Description of health condition studied
Reducedovarian reserve.
ICD-10 code
E28.3
ICD-10 code description
Primary ovarian failure
Primary outcomes
1
Description
The number of retrieved oocytes
Timepoint
Two months after prp injection
Method of measurement
Count the number
2
Description
The number of MII oocyte obtained
Timepoint
Two months after prp injection
Method of measurement
Count the number
3
Description
Increase in AMH
Timepoint
The day of the prp injection, and then two months after the prp injection
Method of measurement
laboratory test
Secondary outcomes
1
Description
IVF cycle cancellation rate
Timepoint
Two months after PRP injection
Method of measurement
Count the number
2
Description
Clinical pregnancy rate
Timepoint
6 weeks after embryo transfer
Method of measurement
Vaginal ultrasound
3
Description
live birth rate
Timepoint
9 months after embryo transfer
Method of measurement
Count the number
4
Description
ongoing pregnancy rate
Timepoint
20 weeks after embryo transfer
Method of measurement
Ultrasound
Intervention groups
1
Description
Intervention group: 29 infertile women with reduced ovarian reserve between 18 and 45 years of age with the administration of platelet-rich plasma alone, which is prepared and injected as follows: about 8.5 cc of the patient's blood sample in two tubes containing total anticoagulant and centrifuged the sample for 10 minutes at 1600 rpm, after the end of the first round of centrifugation, transfer the upper turbid plasma to another tube and centrifuge again for 6 minutes at 3500 rpm we show At the end of the second cycle, a white deposit should be seen at the bottom of the tube. Discard the supernatant solution containing platelet-free plasma and gently stir the remaining amount and inject one and a half cc of PRP with a concentration of approximately 4-5 times that of platelets into the ovary with the help of a follicular aspiration needle under ultrasound guidance
Category
Treatment - Drugs
2
Description
Control group: 59 infertile women with reduced ovarian reserve between 18 and 45 years without administration of platelet-rich plasma
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center of Hormozgan University of Medical Sciences
Full name of responsible person
Dr Maryam Azizi Kutenaee
Street address
Shahid Mohammadi Hospital, Parastar Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 0755
Email
maryamazizikut86@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr Vali Alipour
Street address
Emam Hossein Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0393
Email
research@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr Maryam Azizi Kutenaee
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Mohammadi Hospital, Parastar Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 0755
Email
maryamazizikut86@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr Maryam Azizi Kutenaee
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Mohammadi Hospital, Parastar Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 0755
Email
maryamazizikut86@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr Ensieh Salehi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Shahid Mohammadi Hospital, Parastar Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 0755
Email
salehiensieh@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
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data will be presented in the article after analysis
When the data will become available and for how long
2025
To whom data/document is available
Academic researchers and gynecologists and obstetricians
Under which criteria data/document could be used
Clinical use in patients with reduced ovarian reserve
From where data/document is obtainable
corresponding author of the article
What processes are involved for a request to access data/document