The aim of the study is to investigate an effect of PRP on endometrial growth and regeneration in subjects with asherman syndrome.
Design
Clinical trial, parallel control group, non-randomized
Settings and conduct
A clinical trial study with control group and non-randomized.
Participants/Inclusion and exclusion criteria
Inclusion criteria intrauterine adhesion according to 3D sonography; sonohysterography; hysterosalpingography; hysteroscopy.
Excluding criteria: unsatisfaction; age more than 50; weight more than 100 kg; menopause; pregnancy; malignancy; coagulopathy.
Intervention groups
For this study, a questionnaire was designed which include demographic data, Lab & check up results before and after treatment. After getting consent, data will be gathered by questionnaire the cases will undergo hysteroscopy and intrauterine adhesion will be determined by ASRM score.2 days after hysteroscopy 10 ml of PRP will be injected in the uterine cavity but no injection will be done in control group. All the cases and controls were undergone diagnostic hysteroscopic for 4 to 6 weeks after the intervention to evaluate intrauterine adhesion by ASRM score.
Main outcome variables
Adhesion scoring
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110509006420N17
Registration date:2018-08-02, 1397/05/11
Registration timing:registered_while_recruiting
Last update:2018-08-02, 1397/05/11
Update count:0
Registration date
2018-08-02, 1397/05/11
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intrauterine infusion of autologous platelet-rich plasma in women with Asherman's syndrome
Public title
Autologous platelet-rich plasma in women with Asherman's syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with Asherman's syndrome who have been diagnosed with ultrasound, sonography, hysterography or hysteroscopy.
Exclusion criteria:
Severe cervical stenosis
Coagulation disorders
Mullerian anomaly
systemic disorders
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:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Bouali Avenue
City
YAZD
Province
Yazd
Postal code
8916877391
Approval date
2018-06-22, 1397/04/01
Ethics committee reference number
IR.SSU.MEDICINE.REC.1396.256
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
Adhesion scoring
Timepoint
4 to 6 weeks after hysteroscopy
Method of measurement
With hysteroscopy & ASRM score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Releasing adhesions and injections of 1 cc PRP( platelets reached plasma ) into the uterine cavity.
Category
Treatment - Surgery
2
Description
Control group: Hysteroscopy and adhesion releasing
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Reasech and Clinical Center for Infertility
Full name of responsible person
Maryam Eftekhar
Street address
Bouali
City
YAZD
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
ِDR.Mohammad Reza Mirjallili
Street address
Bahonar
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3725 8770
Email
Info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Maryam Eftekhar
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
7744389169
Phone
+98 35 3824 2563
Email
Eftekharmaryam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Eftekhar
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
7744389169
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Eftekhar
Position
Associated proffesor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
7744389169
Phone
+98 35 3824 7085
Email
eftekharmaryam@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
Because of the privacy of patients
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
Study protocol,Statistical Analysis Plan,Informed Consent Form,Informed Consent Form and Analytic Code will be available.
When the data will become available and for how long
After publishing article.for 5 years
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Use in retrospective study
From where data/document is obtainable
Yazd reasearch and clinical center for infertility
What processes are involved for a request to access data/document
Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, request is referred to the research experts and then get the data