evaluation and comparison of the effect of two different Estrogen doses in prevention of synechia after hysteroscopic treatment of Asherman syndrome patients
Design
60 patients with moderate to severe Asherman syndrome who refer to gynecology clinic of Imam Reza Hospital, after Hysteroscopic resection of synechia based on inclusion citeria, will be randomly divided to two groups of 30 people.
Settings and conduct
Concern about high risk of synechia recurrence after surgical hysteroscopic treatment of Asherman syndrome and also no consensus on appropriate Esterogen dose after surgery to effectively lead to creation of endometrium and prevent the recurrence of synechia are the reasons of this study. This study will be done on patients with moderate to severe Asherman syndrome referring to gynecology clinic of Imam Reza Hospital. Based on a randomization table provided by a computer, these patients are divided to two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all symptomatic patients (infertility or cyclic pelvic pain) referring to gynecology clinic of Imam Reza Hospital who are diagnosed with moderate to severe Asherman syndrome, after acquisition of consent will be included in the study.
Exclusion criteria: another pathology in pelvic exam -history of Uterine myoma or gynecology cancer -hormone consumption during past month-history of genital tuberculosis and -contraindication for hormone therapy.
Intervention groups
Control group receives conjugated Estrogen with 2.5 milligram dose daily and intervention group receives 5 milligram dose (through two doses) for 40 days. In the last 10 days,10 milligram of Medroxyprogestron will also be daily prescribed.
Main outcome variables
frequency and intensity of synechia, frequency of people with amenorrhea and hypomenorrhea, frequency of infertility, frequency of miscarriage and intensity of pelvic pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141230020486N3
Registration date:2018-02-04, 1396/11/15
Registration timing:registered_while_recruiting
Last update:2018-02-04, 1396/11/15
Update count:0
Registration date
2018-02-04, 1396/11/15
Registrant information
Name
Leili Hafizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2608
Email address
hafizil@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of Mashhad University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two different Estrogen doses in prevention of synechia after hysteroscopic treatment of Asherman syndrom patients
Public title
Comparison of two different Estrogen doses in prevention of synechia after hysteroscopic treatment of Asherman syndrom patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all symptomatic patients (infertility or cyclic pelvic pain) referring to gynecology clinic of Imam Reza Hospital who are diagnosed with moderate to severe Asherman syndrome.
Exclusion criteria:
Another pathology in pelvic exam
History of Uterine myoma or gynecology cancer
hormone consumption during past month
History of genital tuberculosis
contraindication for hormone therapy
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done through a randomization table provided by a computer. In order to conceal the randomized allocation of the two groups, sealed and numbered envelopes will be used. When a patients refer, envelopes are opened and the treatment methods will be determined.
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 Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2016-12-15, 1395/09/25
Ethics committee reference number
IR.MUMS.fm.REC.1395.365
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
Percentage of people who face recurrence of synechia after treatment of Asherman syndrom
Timepoint
2 months after using of estrogen
Method of measurement
After treatment period and and bleeding are over, all patients will again go through hysteroscopy and uterine cavity condition will be investigated.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: after surgery, patients receives Estrogen with 2.5 milligram dose daily for 40 days. In the last 10 days,10 milligram of Medroxyprogestron will also be daily prescribed.
Category
Treatment - Drugs
2
Description
Intervention group: after surgery, patients receives 5 milligram dose (through two doses) for 40 days. In the last 10 days,10 milligram of Medroxyprogestron will also be daily prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Leili Hafizi
Street address
Emam Reza Sq, Ebne-sina Ave, Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2608
Email
hafizil@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Leili Hafizi
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Sq. Ebne-sina Ave, Emam Reza hosital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2608
Fax
Email
hafizil@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Leili Hafizi
Position
Associated Proffesor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Sq. ebne-sina Ave, Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2608
Fax
Email
hafizil@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Leili Hafizi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Sq, Ebne-sina Ave, Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2608
Fax
Email
hafizil@mums.ac.ir
Web page address
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 patients are made unidentifiable.
When the data will become available and for how long
The data can be accessible for specific organization request 6 month after the article is published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
In case those people asking for data have the intention of optimizing the study a data and producing more results, access to data is allowed.
From where data/document is obtainable
Through sending an email to the corresponding author, data will be obtainable.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.