The purpose of this study; The effect of PRP (enriched platelet) injection into one of the ovaries and its comparison with other ovaries in women with poor ovarian response.
Design
A clinical trial with the control group, with parallel, non-random, phase 4 groups on 12 patients.
Settings and conduct
In 12 patients with ovarian dysfunction referred to Valiasr Infertility Clinic, ovarian stimulation begins with ovulation-stimulating drugs, and immediately after the follicle reaches 17 mm, the egg is removed at the same time; 4 ccs of enriched platelets (PRP) are injected into one ovary at four points under anesthesia and then in vitro fertilization (IVF) is performed. PRP is not performed in the other ovary (control).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with a history of poor ovarian function and normal sperm analysis
Exclusion criteria: hematological diseases; chromosomal or genetic disorders; Uterine disorders; Hemoglobin level less than 11 grams per deciliter and platelets less than one hundred and fifty thousand cubic millimeters; Systemic use of corticosteroids within two weeks before the procedure.
Intervention groups
Intervention group: 12 patients with the poor ovarian function will be included in the study and will be stimulated to ovulate. Then when the follicle reaches 17 mm at the same time as the metaphase 2 egg is picked up; 4 ccs of platelet-rich plasma is injected at four points in an ovary under anesthesia by the Unit Infertility Fellowship.
Control group: The ovaries of the same 12 patients with poor ovarian function in which the ovaries do not inject platelet-rich plasma.
Main outcome variables
The number of oocytes; Number of mature oocytes ; Antimullerian hormone levels; Follicle-stimulating hormone (FSH) levels.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210828052310N1
Registration date:2021-10-02, 1400/07/10
Registration timing:prospective
Last update:2021-10-02, 1400/07/10
Update count:0
Registration date
2021-10-02, 1400/07/10
Registrant information
Name
Saeedeh Shahsavari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 3280
Email address
saeedeh.shahsavari@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-19, 1400/07/27
Expected recruitment end date
2022-10-19, 1401/07/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of platelet-rich plasma injection in an ovary in cases of poor ovarian function (poor response)
Public title
Impact of platelet-rich plasma on an ovary in cases of poor ovarian function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of less than 3 eggs per cycle
Antimullerian hormone less than 0.5
Antral follicles less than 5
Existence of 10 million sperm in sperm analysis
At least three percent of normal sperm morphology
Exclusion criteria:
Immunological diseases of patients
Hematologic disease
Chromosomal or genetic disorder
Hemoglobin level less than 11 grams per deciliter and platelets less than one hundred and fifty thousand per cubic millimeter
Systemic use of corticosteroids within two weeks before the procedure
Absence of underlying disease of infertile women
No contraindications for pregnancy
Uterine disorders
Submucosal myoma
Asherman syndrome
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Not randomized
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 Tehran University of Medical Sciences
The oocyte retrieval day in the first and second cycles.
Method of measurement
Based on embryologist assessment
3
Description
Anti Mullerian Hormone level
Timepoint
The second day of cycles 1 and 2
Method of measurement
Blood test
4
Description
Follicle Stimulating Hormone level.
Timepoint
The second day of cycles 1 and 2
Method of measurement
Blood test
Secondary outcomes
1
Description
Number of Embryo
Timepoint
Three to six days after fertilization
Method of measurement
Based on the opinion of the embryologist
Intervention groups
1
Description
Intervention group: 12 patients with poor ovarian function referred to Valiasr Infertility Clinic will participate in the study during the year 1400. The ovulation stimulation is done by prescribing Dofaston 10 mg twice a day from the day of 2-3 menstrual cycles to the day of ovulation. Then when the follicle reaches 17 mm at the same time as the oocyte of metaphase two is removed; 4 ccs of platelet-rich plasma is injected at four points of the ovary under anesthesia by the infertility unit.
Category
Treatment - Drugs
2
Description
Control group: On the opposite side of the ovary, the same twelve patients with poor ovarian function do not inject platelet-rich plasma.
6th floor, Ghods St, Keshavarz Blvd.Central Organization of the University, Deputy of Research and Technology of Tehran University of Medical Sciences.
City
Tehran
Province
Tehran
Postal code
۵۳۷۶۱-۱۴۱۷۶
Phone
+98 21 8163 3619
Email
m.sahraian@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of Research and Technology of Tehran 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
Saeide Shahsavari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bandarabbas University of Medical sciences, Shahid Chamran Blvd.
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
saiede.shahsavari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Saeide Shahsavari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hormozgan University of Medical sciences, Shahid Chamran Blvd.
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
saeide.shahsavari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fedyeh Haghollhi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Vali -Asr Reproductive Health Research Center,Imam Khomeini Complex Hospital,Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Email
fedyeh_hagh@yahoo.com
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
patients privacy
Study Protocol
Undecided - It is not yet known if there will be 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
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