The effect of platelet-rich plasma(PRP) on ovarian reserve in patients undergoing laparoscopic endometriosis surgery
Design
A clinical trial with two intervention and control groups performed on 30 patients undergoing laparoscopic endometriosis.
Settings and conduct
This study will be performed in Hazrat Rasool Akram Hospital. After providing the necessary explanations about this plan, written consent will be obtained from the patients. In the intervention group, venous blood is taken from patients and platelet-rich plasma is isolated and injected to ovary with cyst under laparoscopic surgery. No blinding has been done
Participants/Inclusion and exclusion criteria
Inclusion criteria included endometriosis women candidates for laparoscopic surgery with a diameter of 4 to 10 cm, which was confirmed by ultrasound, body mass index (BMI = mass (kg) / height^2 (m)) between 18.5 to 30, have not received hormonal drugs, especially GnRH agonists in the last 3 months and the amount of AMH is less than 1/1 ng. Women with a body mass index (BMI) of 30 or less than 5.18, people with autoimmune disorders and malignancies, sexually transmitted diseases, infectious diseases, infertility following tubal obstruction, and patients with endocrine disorders such as thyroid dysfunction And patients taking anticoagulants are excluded from the study.
Intervention groups
Both intervention and control groups undergo laparoscopic endometriosis surgery. In the intervention group, platelet-rich plasma is injected into the ovarian tissue during laparoscopy. Serum AMH levels are measured in both groups 6 months after surgery.
Main outcome variables
AMH levels and number of antral follicles (AFC)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191123045476N3
Registration date:2021-12-01, 1400/09/10
Registration timing:prospective
Last update:2021-12-01, 1400/09/10
Update count:0
Registration date
2021-12-01, 1400/09/10
Registrant information
Name
Samaneh Rokhgireh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9283
Email address
rokhgireh.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2022-05-10, 1401/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of autologous PRP on ovarian reserve in patients undergoing laparoscopic endometriosis surgery
Public title
The effect of PRP on ovarian reserve
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Endometriosis women are candidates for laparoscopic surgery with a diameter of 4 to 10 cm, which is confirmed by ultrasound
BMI between 18.5 and 30 have.
Have not received hormonal drugs, especially GnRH agonists, in the last 3 months.
AMH should be less than 1/1 ng.
Exclusion criteria:
Women with a body mass index (BMI) greater than 30 or less than 18/5
People with autoimmune disorders and malignancies
People with sexually transmitted and infectious diseases
People with infertility following tubal obstruction and patients with endocrine disorders such as thyroid dysfunction
Patients who use anticoagulant drugs
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
اn this study, restricted randomization sampling method is used that the study groups have equal sample size. Random allocation rule is one of the limited random sampling methods used in the present study. And patients are equally divided into two groups. On how to randomize, researchers first determine a total sample size, then randomly assign a set of them to group A and the rest to group B. For example, in a study with a sample size of 200 people, 100 balls For intervention group A and 100 balls, for intervention group B, it is placed in a lottery container and then the balls are randomly removed from the container without replacement and the created sequence is recorded. This method is used for two or more group trials.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Intervention group: the patient is injected with concentrated plasma, which is rich in platelets, according to the study protocol. Before the operation, 20 cc of the patient's blood is taken in a PRP tube (GeoPRP-regenlab kit). The tube is completely shaken and its contents are centrifuged at 3600 rpm for 6 minutes and the surface PRP is collected with a 16-gauge needle. The result is about 4-8 cc of PRP. After laparoscopy cystectomy, 2-4 cc is injected subcortically into the ovary with endometrial cyst.
Category
Treatment - Drugs
2
Description
Control group: In the control group, endometriosis patients with ovarian cysts undergo only laparoscopic surgery and PRP injection is not performed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Samaneh Rokhgireh
Street address
Starkhan.Mansouri Street. Rasoul Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
s.rokhgireh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samaneh Rohkgireh
Street address
Sattarkhan-Mansoori Street.Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
s.rokhgireh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Samaneh Rokhgireh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sattar Khan .Mansouri St. Rasoul Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
s.rokhgireh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samaneh Rokhgireh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sattar Khan .Mansouri St. Rasoul Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
s.rokhgireh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samaneh Rokhgireh
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sattar Khan .Mansouri St. Rasoul Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
s.rokhgireh@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
Following the publication of the article, confidential information such as patient profile and Hospital, ... deletion and other information Will be made available to researchers
When the data will become available and for how long
After publishing the article
To whom data/document is available
Medical specialists
Under which criteria data/document could be used
Medical professionals can turn to data for research purposes gain access
From where data/document is obtainable
Refer to the email of the responsible author
What processes are involved for a request to access data/document
Official and academic email to the responsible author