Investigating the effect of hyaluronic acid injection in eliminating adhesions in hysteroscopy of patients with Asherman's syndrome
Design
This phase 3 clinical trial with a control group, parallel design, using the random allocation rule is performed on 30 patients.
Settings and conduct
This double-blind study will be performed on 30 patients with Asherman's syndrome candidates for hysteroscopy in Yas Hospital Complex.
Participants/Inclusion and exclusion criteria
Inclusion criteria include women with Asherman syndrome who consented to participate in the study. Criteria for not entering: Contraindications for hyaluronic acid consumption, presence of pelvic infections, menopause, pregnancy, history of cervical cancer, and significant underlying diseases.
Intervention groups
All patients undergo hysteroscopy. At the end of hysteroscopy, a Foley catheter is placed for 24 hours and only in the intervention group, 3 cc of hyaluronic acid gel is injected into the uterine cavity using an IUI catheter.
For all patients, hormone therapy is prescribed for two months, including estradiol 2 mg in the morning and 2 mg at night, as well as progesterone ampoule on day 30 and day 60 after the hysteroscopy.
Main outcome variables
Uterine adhesions and endometrial thickness are evaluated two months after the hysteroscopy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N42
Registration date:2024-06-08, 1403/03/19
Registration timing:prospective
Last update:2024-06-08, 1403/03/19
Update count:0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2026-01-20, 1404/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of hyaluronic acid injection in eliminating adhesions in hysteroscopy of patients withAsherman's syndrome
Public title
The effect of hyaluronic acid injection in eliminating adhesions in hysteroscopy of patients with Asherman's syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with Asherman syndrome
Patient consent to participate in the study
Exclusion criteria:
Contraindications for the use of hyaluronic acid
Presence of pelvic infections
Menopause
Pregnancy
History of cervical cancer
Severe coagulative disorders
Presence of underlying diseases such as thrombophilia, cardiovascular and respiratory disorders.
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: First, 15 letters A and 15 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (endometrial incision) or B (control group) are determined by a lot.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the doctor who measures the results do not know about the treatment group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Ethics committee of Tehran University of Medical Sciences, Ghods Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2024-04-20, 1403/02/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.008
Health conditions studied
1
Description of health condition studied
Intrauterine adhesions
ICD-10 code
N85.6
ICD-10 code description
Intrauterine synechiae
Primary outcomes
1
Description
intrauterine adhesions
Timepoint
Once, two months after the intervention
Method of measurement
Sonohysterography
Secondary outcomes
1
Description
Endometrial thickness
Timepoint
Once, two months after the intervention
Method of measurement
Sonography
Intervention groups
1
Description
Intervention group: The patients undergo hysteroscopy. At the end of the hysteroscopy, 3 cc of hyaluronic acid gel is injected into the uterine cavity using the IUI catheter. Then the Foley catheter is placed for 24 hours. Hormone therapy is prescribed for two months, including estradiol 2 mg in the morning and 2 mg at night, as well as progesterone ampoule on day 30 and day 60 after hysteroscopy.
Category
Treatment - Drugs
2
Description
Control group: The patients undergo hysteroscopy. At the end of the hysteroscopy, the Foley catheter is placed for 24 hours. Hormone therapy is prescribed for two months, including estradiol 2 mg in the morning and 2 mg at night, as well as progesterone ampoule on day 30 and day 60 after hysteroscopy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mirza Kochak Khan hospital
Full name of responsible person
Fatemeh Davari Tanha
Street address
Yas Hospital Complex, Next to the Sarv St., North Nejatollahi St., Karim khan Ave.
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 4216 0000
Email
fdavaritanha@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Dean of Research of Tehran University of Medical Sciences, Dr. Akbari Sari
Street address
Vice-Dean of Research, Tehran University of Medical Sciences, Floor 6, Qods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 8163 8936
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas Hospital Complex, Next to the Sarv St., North Nejatollahi St., Karim khan Ave.
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8831 3955
Fax
+98 21 8831 3955
Email
fdavaritanha@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas Hospital Complex, Next to the Sarv St., North Nejatollahi St., Karim khan Ave.
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8831 3955
Fax
+98 21 8831 3955
Email
fdavaritanha@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas Hospital Complex, Next to the Sarv St., North Nejatollahi St., Karim khan Ave.
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8831 3955
Fax
+98 21 8831 3955
Email
fdavaritanha@sina.tums.ac.ir
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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified participants.
When the data will become available and for how long
After manuscript published
To whom data/document is available
No limitations
Under which criteria data/document could be used
The data is only available to the project manager, Dr. Davari, and any analysis must be done with her opinion.
From where data/document is obtainable
Dr. Davari through email (fdavaritanha@sina.tums.ac.ir)
What processes are involved for a request to access data/document
Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Davari.