Comparison of the effectiveness of hormone therapy alone with hormone therapy and platelet-rich plasma in the improvement of Asherman's syndrome after hysteroscopy in educational centers of Isfahan University of Medical Sciences
Comparison of the effectiveness of hormone therapy alone with hormone therapy with platelet-rich plasma in the improvement of Asherman's syndrome after hysteroscopy in educational centers of Isfahan University of Medical Sciences
Design
After the definitive diagnosis of the disease and obtaining informed consent, the demographic information of the patients, including age and midwifery information, menstrual rate, etc., is recorded and the patients who have entry criteria are divided into two groups.
The severity of intrauterine adhesions is determined by clinical evidence and hysteroscopic findings. For the first group, hormone therapy alone, and for the second group, platelet-rich hormone therapy will be performed after hysteroscopy.
In the control group, after hysteroscopy and removal of adhesions, they are treated only with hormone therapy. Finally, patients in both groups were examined hysteroscopically after 6 to 8 weeks later for recurrence and adhesion.
Settings and conduct
Educational centers of Isfahan University of Medical Sciences in 1398
Participants/Inclusion and exclusion criteria
Entrance: 1- Clinical diagnosis of Asherman's syndrome; 2- Age 18 to 43 years; 3- Conscious consent to participate in the study.
Exit: 1- Age less than 18 and more than 43 years; 2- Simultaneous infection of the uterus and vagina; 3- Hemoglobin less than 11; 4- Platelet less than 150,000; 5 - History of anticoagulant use; 6- Dissatisfaction with entering the study.
Intervention groups
PRP and hormone therapy
Main outcome variables
Type of treatment; uterine adhesion grade; menstrual period; BMI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200316046789N1
Registration date:2022-02-11, 1400/11/22
Registration timing:retrospective
Last update:2022-02-11, 1400/11/22
Update count:0
Registration date
2022-02-11, 1400/11/22
Registrant information
Name
Mahdi Hadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3568 8890
Email address
m.hadian72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
2020-03-20, 1399/01/01
Actual recruitment end date
2021-09-22, 1400/06/31
Trial completion date
2021-09-22, 1400/06/31
Scientific title
Comparison of the effectiveness of hormone therapy alone with hormone therapy and platelet-rich plasma in the improvement of Asherman's syndrome after hysteroscopy in educational centers of Isfahan University of Medical Sciences
Public title
Evaluation of the effectiveness of platelet-rich plasma in the treatment of Asherman's syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of Asherman's syndrome
Age: 18 to 43 years old
Informed consent to participate in the study
Exclusion criteria:
Simultaneous infection of the uterus and vagina
Hemoglobin less than 11
Platelet less than 150,000
History of anticoagulant use
Dissatisfaction with entering the study
Age
From 18 years old to 43 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After definitive diagnosis and informed consent, patients are divided into two groups based on the time of referral. The selection of patients in two groups is completely random.
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 Isfahan University of Medical Sciences
Street address
Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-03-09, 1398/12/19
Ethics committee reference number
IR.MUI.MED.REC.1398.671
Health conditions studied
1
Description of health condition studied
Asherman syndrome
ICD-10 code
N85.6
ICD-10 code description
Intrauterine synechiae
Primary outcomes
1
Description
Uterine adhesion grade
Timepoint
6 to 8 weeks later hysteroscopy
Method of measurement
Histroscopy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:case (PRP and hormone therapy group) (n = 30/each groups). The selection of patients in two groups was completely random. 8.5 ml of peripheral venous blood of patient was taken through a syringe containing 1.5 ml of citrate acid. It was then centrifuged immediately at 1000 g for 10 min. The buffy coat layer and the plasma layer were collected and transferred to another tube to be centrifuged again at 3500 g for 5 min. 1.5 ml of PRP with a good concentration were finally obtained.To perform the plan for patients in the case group, after removal of the adhesion by hysteroscopy, PRP 1ml is injected into the uterine cavity wall . They are then given hormone therapy, the usual regimen is 2.5 mg of conjugatedestrogen once a day for four weeks.A progestin such as medroxyprogesterone acetate at a dose of 10 mg is added to the treatment in the last week.Finally,6 to 8 weeks later patients in both groups were examined hysteroscopically. The intrauterine adhesion grade and menstruation pattern before and after the intervention were evaluated.
Category
Treatment - Drugs
2
Description
Control group: control (hormone therapy)(n = 30/each groups) In the control group, after hysteroscopy and removal of adhesions, they are treated only with hormone therapy. They are then given hormone therapy, the usual regimen is 2.5 mg of conjugatedestrogen once a day for four weeks.A progestin such as medroxyprogesterone acetate at a dose of 10 mg is added to the treatment in the last week. Finally,6 to 8 weeks later patients in both groups were examined hysteroscopically. The intrauterine adhesion grade and menstruation pattern before and after the intervention were evaluated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Zahra Derakhshandeh
Street address
Ostad Motahari St., Felezi Bridge, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8184853541
Phone
+98 31 3234 6338
Email
Zderakhshandeh2020@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Hezar Jerib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Derakhshandeh
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan University of Medical Sciences, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3370
Email
Zderakhshandeh2020@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Derakhshandeh
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan University of Medical Sciences, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3370
Email
Zderakhshandeh2020@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Derakhshandeh
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan University of Medical Sciences, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
Zderakhshandeh2020@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
All data can be shared after people have not been identified
When the data will become available and for how long
Start of access period from 1399
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For future researches
From where data/document is obtainable
09133057797
Dr. Zahra Derakhshandeh
What processes are involved for a request to access data/document
Contact the project executor
Send documents
Receive data