Evaluation of safety and effectiveness of placenta mesenchymal stem cell-derived exosomes on embryo implantation rate in women with recurrent implantation failure: a clinical trial
Evaluation of safety and effectiveness of placenta mesenchymal stem cell-derived exosomes on embryo implantation rate in women with recurrent implantation failure
Design
This study is a non-blinded clinical trial that will be conducted on 15 qualified pregnant women and the patients will be included in the intervention group.
Settings and conduct
This non-blinded study will be conducted in Motazadi Hospital, Kermanshah. After separating the mesenchymal stem cells from the placenta and checking the specific cell markers, the stem cells are cultured. In the following, the desired exosomes are isolated and their characteristics, including the presence of surface markers, are also examined. Then the obtained exosome precipitate is dissolved in PBS and frozen at -80°C until use.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with repeated implantation failure (at least two failed embryo transfer cycles); FSH below 10 mIU/Ml; Normal infectious tests (VDRL, HCV, HBS Ag, HIV)
Exclusion criteria: Thin endometrium; Chromosomal disorders of couples
Spouse's spermogram disorder; Immune system diseases including rheumatoid arthritis, autoimmune thyroid, lupus; History of cancer, chemotherapy or radiation therapy, use of immunosuppressive drugs including corticosteroids during the last three months; History of pregnancy
Intervention groups
The intervention group will receive one exosome unit equal to 2-1.5 x 1010 particles/unit or 200 μg of protein intrauterine and two days before embryo transfer.
Main outcome variables
Ague
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N223
Registration date:2024-08-09, 1403/05/19
Registration timing:prospective
Last update:2024-08-09, 1403/05/19
Update count:0
Registration date
2024-08-09, 1403/05/19
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-05, 1403/06/15
Expected recruitment end date
2025-05-05, 1404/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and effectiveness of placenta mesenchymal stem cell-derived exosomes on embryo implantation rate in women with recurrent implantation failure: a clinical trial
Public title
Effectiveness of placenta mesenchymal stem cell-derived exosomes on embryo implantation rate in women with recurrent implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with repeated implantation failure (at least two failed embryo transfer cycles)
FSH below 10 mIU/mL
Normal infectious tests (VDRL, HCV, HBS Ag, HIV)
Exclusion criteria:
Thin endometrium
Asherman syndrome
Chromosomal disorders of couples
Spouse's spermogram disorder
Immune system diseases including rheumatoid arthritis, autoimmune thyroid, lupus
History of cancer, chemotherapy or radiation therapy, use of immunosuppressive drugs including corticosteroids during the last three months
History of pregnancy
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2024-07-24, 1403/05/03
Ethics committee reference number
IR.KUMS.REC.1403.198
Health conditions studied
1
Description of health condition studied
Recurrent Implantation Failure
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Fever and chills
Timepoint
The end of the study
Method of measurement
Asking the patient
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive one exosome unit equal to 2-1.5 x 1010 particles/unit or 200 μg of protein intrauterine and two days before embryo transfer.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motazedi Hospital
Full name of responsible person
Rezvan Asgari
Street address
Motazedi Hospital, Ferdowsi Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3724 6351
Email
R.asgari33@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Kamran Mansouri
Position
Member of the academic staff of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Molecular medicine
Street address
Medical Biology Research Center, Faculty of Medicine, Nurse Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6473
Email
kamranmansouri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Kamran Mansouri
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Molecular medicine
Street address
Medical Biology Research Center, Faculty of Medicine, Nurse Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6473
Email
kamranmansouri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Kamran Mansouri
Position
Member of the academic staff of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Molecular medicine
Street address
Medical Biology Research Center, Faculty of Medicine, Nurse Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6473
Email
kamranmansouri@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