Cell therapy with use of mesenchymal stem cells in infertile women with Thin Endometrium
Design
Phase 1 clinical trial without control group, on 10 patients
Settings and conduct
In this study, infertile women will be selected according to the inclusion and exclusion criteria. Patients will be signed the informed consent.
Patients will be received three injections of umbilical cord mesenchymal stem cells and their secretom with the intervals of one month.
Participants/Inclusion and exclusion criteria
Infertile women with thin endometrium, Endometrium thickness less than 7 mm, Patients who have ineffective routine treatment; Patients who have other uterine diseases, Patients who have systemic disorders such as diabetes.
Intervention groups
Patients will be received mesenchymal stem cells and their secretome
Main outcome variables
Endometrium thickness, Implantation rate, live birth rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230222057500N1
Registration date:2023-04-03, 1402/01/14
Registration timing:prospective
Last update:2023-04-03, 1402/01/14
Update count:0
Registration date
2023-04-03, 1402/01/14
Registrant information
Name
Saeedeh Torabi Goudarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4305 2000
Email address
s-torabig@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cell therapy with use of mesenchymal stem cells in infertile women with Thin Endometrium
Public title
Cell therapy with use of mesenchymal stem cells in infertile women with Thin Endometrium
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with thin endometrium
patient with thin endometrium for whom drugs and other treatments were ineffective
Endometrial thickness less than 7 mm
Embryo transfer is cancelled because of thin endometrium
Age between 20 and 44 years
HBsAg negative, HCV negative, HIV negative, CMV negative
Exclusion criteria:
Abnormal karyotype
Contraindications to hormone replacement therapy
Systemic diseases such as hypertension, diabetes
Other uterine diseases including uterine malformations, large myoma, endometrial tuberculosis, endometriosis
Autoimmune diseases such as rheumatoid arthritis, lupus
Unable to adhere to the follow-up
Age
From 20 years old to 44 years old
Gender
Female
Phase
1
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
Research Ethics Committees of Research Institute for Oncology, Hematology and Cell Therapy - Tehran
Before the intervention and 1, 2 and 3 months after the first intervention
Method of measurement
Vaginal sonography
Secondary outcomes
1
Description
The effect of cell therapy on fertility rate of patients
Timepoint
15 days after embryo transfer
Method of measurement
Using sonography and serum beta-human chorionic gonadotropin (β-hCG) level assessment by enzyme-linked immunosorbent assay (ELISA) or chemi luminescence
Intervention groups
1
Description
Intervention group: patients will be received three injections of Umbilical cord-derived Mesenchymal Stem Cells and their secretome.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Fertility Research Center
Full name of responsible person
Saeedeh Torabi Goudarzi
Street address
Valiasr Fertility Research Center,Imam Khomeini Hospital, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1616
Fax
Email
vrhrc@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Vice President of Research and Technology, 6th Floor, Central Organization of Tehran University of Medical Sciences, Corner of Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
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
Saeedeh Torabi Goudarzi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Applied Cell Sciences
Street address
No. 88, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Email
s-torabig@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nasim Vosoughi _ Mehdi Yousefi _ Saeedeh Torabi Goudarzi
Position
Associate Professor _ Associate Professor _ PhD candidate
Latest degree
Ph.D.
Other areas of specialty/work
Cell Therapy _ Immunology _ Applied Cell Sciences
Street address
No. 88, School of Advanced Technologies in Medicine, Italia St., Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Email
s-torabig@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeedeh Torabi Goudarzi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Applied Cell Sciences
Street address
No. 88, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Email
s-torabig@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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