The patients who had eligible criteria randomly divided in two groups 43 patients in each group.
Scoring of intra uterine adhesion was done by (ASRM) score, which include hysteroscopic results and clinical symptoms.
Study condition and probable side effect of Hyaloronic acid gel were explained for all cases who had eligible criteria. For this study a questionnaire was designed which include demographic data, Lab & check up results before and after treatment. After getting consent, data gathered by questionnaire the cases were undergone hysteroscopy and intrauterine adhesion was determined by ASRM score. Then uterine cavity expanded by saline normal 0.9%.
10 CC Hyaloronic acid gel injected in the uterine cavity in case group, but no injection in control group. In both case and control group Cephasoline was injected during procedure. All the cases and controls were undergone diagnostic hysteroscopic for 4 to 6 weeks after intervention to evaluate intrauterine adhesion by ASRM score.
General information
Acronym
(HGS)
IRCT registration information
IRCT registration number:IRCT201703057513N14
Registration date:2017-10-07, 1396/07/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-07, 1396/07/15
Registrant information
Name
Hatav Ghasemi Tehrani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 113 4081
Email address
tehrani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research Of Preventive Gynecology Research Center Of Shahid Beheshti Medical School
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determine the effect of hyaluronic acid gel on the hysteroscopic outcomes following surgical removal of intra-uterine adhesions
Public title
Determine the effect of hyaluronic acid gel on the hysteroscopic outcomes following surgical removal of intra-uterine adhesions in women refferd to the taleghani clinic of ShahidBeheshti university of medical sciences in Tehran in 1394-95
Purpose
Treatment
Inclusion/Exclusion criteria
Including 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
Age
From 18 years old to 46 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
43
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Etical comitee of SHAHID BEHESHTI MEDICAL SCHOOL
Street address
SHahid Beheshti Medical University ,Aarabee Street ,University square,Velengac,Tehran
City
TEHRAN
Postal code
81668
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.1007
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
1
Description
Pregnancy Rate
Timepoint
After action for pregnancy
Method of measurement
B HCG
Intervention groups
1
Description
Adhesion release and
hyaluronic gel injection
genewel company (10cc=5gr)
commercial name =Guardix