Effects of transplantation of bone marrow, adipose, and endometrial stem cells on endometrium structure and fertility in Ashermans syndrom and endometrial atrophy
Comparison the effects of transplantation of bone marrow, adipose, and endometrial stem cells on endometrium structure and fertility in Ashermans syndrome and endometrial atrophy
Design
Non-controlled quasi-clinical trials. Sampling method: convenient sampling. Randomized method: in this study, measurements will be performed before and after the intervention, so there will be no randomization. Blinding: blinding will not be performed in this study because only one group will be sampled and the analysis will be compared before and after:
Settings and conduct
In this prospective non-controlling clinical trial, infertile patients referred to the infertility department of of Hamedan University of Medical Sciences who suffer from Asherman syndrome or thin endometrium and have no response to other treatments will be included in this study. Before starting, we will obtain consent form patient for biopsy and transplantation.
2-Diagnosis of Asharman syndrome and thin endometriuom by hysteroscopy and its grading.
3-Determining the thickness of the endometrium by ultrasound and removing endometrial biopsy from the uterus and the fundus using curettage in the proliferative phase .
4-Isolation of mesenchymal cells from bone marrow, adipose tissue, or uterine endometrium (based on the results of an animal study)
5- Cell transplantation
6- Recording the severity and length of menstrual period.
7_ Three month following the transplantation, ultrasound, hysteroscopy and endometrial biopsy will be done for histological examination.
8- Determination of adhesion and thickness of the endometrium by sonography and hysteroscopy
Participants/Inclusion and exclusion criteria
Infertile women with Asherman syndrome and thin endometrium who have not responded to surgical and hormonal treatments.
Intervention groups
Mesenchymal stem cells
Main outcome variables
Endometrium thickness and fibrosis; fertility percent
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190306042948N1
Registration date:2019-04-15, 1398/01/26
Registration timing:prospective
Last update:2019-04-15, 1398/01/26
Update count:0
Registration date
2019-04-15, 1398/01/26
Registrant information
Name
Sara Soleimani Asl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0023
Email address
s.soleimaniasl@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of transplantation of bone marrow, adipose, and endometrial stem cells on endometrium structure and fertility in Ashermans syndrom and endometrial atrophy
Public title
Stem cell- based therapy in Asherman syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile patients referred to the Fatemieh infertility department of Hamadan University of Medical Sciences who suffer from Asherman syndrome or thin endometrium and did not respond to common treatments such as hormone therapy and surgery.
Exclusion criteria:
Patients with cardiovascular, renal disorders
Patients with Syphilis, Hepatitis, AIDS
Patients with husband infertility factor
Endometrial thickness more than 7 mm
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
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
Ethics Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh BLV. Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517865178
Approval date
2019-02-22, 1397/12/03
Ethics committee reference number
IR.UMSHA.REC.1397.865
Health conditions studied
1
Description of health condition studied
Asherman Syndrome
ICD-10 code
N97.2
ICD-10 code description
Female infertility of uterine origin
2
Description of health condition studied
Endometrial Atrophy
ICD-10 code
A97.2
ICD-10 code description
Female infertility of uterine origin
Primary outcomes
1
Description
Endometrial thickness
Timepoint
Before transplantation and every month for one year after cell therapy
Method of measurement
Ultrasonography
2
Description
Menstruation
Timepoint
Monthly for one year after transplantation
Method of measurement
Number of menstruation days and used pads
3
Description
Fertility percent
Timepoint
For one year following transplantation
Method of measurement
Routine pregnancy tests
Secondary outcomes
1
Description
FSH
Timepoint
Before and three months following cell transplantation
Method of measurement
Blood sampling
2
Description
LH
Timepoint
Before and three months following cell transplantation
Method of measurement
Blood sampling
3
Description
Endometrial adhesion
Timepoint
Before and three month after cell transplantation
Method of measurement
Ultrasonography
Intervention groups
1
Description
Intervention group: Single Stem cells transplanted cell (10000000 cells)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital of Hamadan University of Medical Sciences
Full name of responsible person
Sara Soleimani Asl
Street address
Fertility and Infertility center, Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517865178
Phone
+98 81 3827 7459
Email
s.soleimaniasl@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Shahid Fahmideh BLV. Research and Technology Vice- chancellors, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517865178
Phone
+98 81 3838 0718
Email
s_bashirain@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Sara Soleimani Asl
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Shahid Fahmideh BLV, Faculty of Medicine, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517865178
Phone
+98 81 3838 0572
Email
sr_soleimani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sara Soleimani Asl
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517865178
Phone
+98 81 3838 0023
Fax
Email
s.soleimaniasl@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sara Soleimani Asl
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517865178
Phone
+98 81 3838 0023
Fax
Email
s.soleimaniasl@umsha.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
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After the completion of the study, information on the main results will be shared.
When the data will become available and for how long
After the online publication of the results in the authoritative journal
To whom data/document is available
Researchers and investors in the private sector
Under which criteria data/document could be used
Further study by researchers, an investigation by investors for potential investment in cell therapy
From where data/document is obtainable
Dr. Sara Soleimani Asl
sr_soleimani@yahoo.com
+989144529036
What processes are involved for a request to access data/document
Please send your application to the above-mentioned email address, you will receive requested information for less than one month.