A study on the safety of amniotic membrane uterine transplantation in patients with Asherman's syndrome
Design
The clinical Trial study in Phase 1, without Blinding,
Settings and conduct
Ten sick patients from patients referred to Sarem Hospital. Asherman's patients with intrauterine adhesions and endometrial atrophy with endometrial thickness less than 5 mm who is associated with menstruation and infertility. After selecting patients and performing HIV tests, hepatitis B and C, syphilis, history of the disease, examination, endometrial thickness, Menstrual blood volume, intrauterine adhesions, and neo-angiogenesis before using amniotic membrane and then after it. In all patients, the continued use of hormone is also used.
Participants/Inclusion and exclusion criteria
Aeserman patients with intrauterine adhesions and endometrial atrophy with an endometrial thickness of less than 5 mm
Intervention groups
Patients with Asherman's Syndrome referred to Sarem Women's Hospital
Main outcome variables
Menstrual blood volume, endometrial thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190714044201N1
Registration date:2019-09-15, 1398/06/24
Registration timing:retrospective
Last update:2019-09-15, 1398/06/24
Update count:0
Registration date
2019-09-15, 1398/06/24
Registrant information
Name
AboTaleb Saremi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4467 0666
Email address
dr.saremi@sarem.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-11, 1398/04/20
Expected recruitment end date
2019-09-11, 1398/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of Amniotic Membrane in Asherman's syndrome management
Public title
Safety and efficacy of Amniotic Membrane in Asherman's syndrome management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Asherman's patients with intrauterine adhesions and endometrial atrophy
endometrial thickness of less than 5 mm
normal functioning of the heart kidneys and lungs
wish to complete the study
Exclusion criteria:
Unwilling to get pregnant
Genital tract inflammation
Cardiovascular diseases
Hormonal Problems Contraceptive Indication of Relative Hormone Therapy
Gastrointestinal diseases
prohibits estrogen use
liver or chronic hepatic failure
Immune system diseases such as lupus, ...
Past and present cancer
Positive serologic evidence of previous or current hepatitis B and C infection as well as HIV and HTLV
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
كميته اخلاق دانشگاه علوم پزشكي ايران
Street address
Tehran, Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-07-10, 1398/04/19
Ethics committee reference number
IR.IUMS.REC.1398.356
Health conditions studied
1
Description of health condition studied
Asherman's Syndrome
ICD-10 code
N85.6
ICD-10 code description
Intrauterine synechiae
Primary outcomes
1
Description
Menstruation
Timepoint
At baseline and 3 and 6 months after intervention
Method of measurement
Number of menstruation days, pads number
2
Description
Endometrial thickness
Timepoint
At baseline and 3 and 6 months after intervention
Method of measurement
Ultrasound
Secondary outcomes
1
Description
Pregnancy Rate
Timepoint
12 month 3 month time frame
Method of measurement
Pregnancy routine tests
2
Description
Implantation Rate
Timepoint
Pregnancy routine tests
Method of measurement
Ultrasound
Intervention groups
1
Description
Patients with Asherman syndrome After Hysteroscopy and adhesions release, the amniotic membrane is placed on the uterine balloon stent and inserted into the uterus. Then 5cc normal saline is injected into the balloon.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sarem Women's Hospital
Full name of responsible person
ِِDr. Maryam Mahmoodinia Maymand
Street address
Ekbatan Town - End of Phase 3
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4467 0883
Fax
Email
mahmoodi.scrc@gmail.com
Web page address
http://saremhospital.org/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sarem Fertility and Infertility Research Center
Full name of responsible person
AboTaleb Saremi
Street address
Phase 3- Ekbatan- Tehran- iran
City
Tehran
Province
Tehran
Postal code
13955144
Phone
+98 21 4467 0883
Email
dr.saremi@sarem.org
Web page address
http://saremfertility.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sarem Fertility and Infertility Research Center
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Sarem Infertility Fertility Research Center
Full name of responsible person
Dr. aboTaleb saremi
Position
Specialist physician
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ekbatan Town, End of Phase 3, Tehran
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4467 0883
Email
dr.mahmoodinia@sarem.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sarem Infertility Fertility Research Center
Full name of responsible person
AboTaleb Saremi
Position
MD
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ekbatan Town, End of Phase 3, Tehran
City
Tehran
Province
Tehran
Postal code
13955144
Phone
+98 21 4467 0883
Email
mahmoodi.scrc@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sarem Women's Hospital
Full name of responsible person
Maryam Mahmoodinia Maymand
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Genetics
Street address
Ekbatan Town, End of Phase 3, Tehran
City
Tehran
Province
Tehran
Postal code
13955144
Phone
+98 21 4467 0883
Email
mahmoodi.scrc@gmail.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
Ethical issue
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available