Investigating the efficacy of exosomes derived from umbilical cord mesenchymal stem cells in treating infertility in women with chemotherapy-induced ovarian failure
The production of exosome for treatment of ovarian failure in females treated with chemotherapy drugs
Design
This is a non-blinded clinical trial that will be conducted on 10 eligible women with ovarian failure 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.
After the exosome injection is complete, and over the desired period of time, various assessments will be conducted to evaluate factors related to follicular growth, hormonal balance, and other ovarian condition improvements in these individuals
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Women with ovarian failure undergoing chemotherapy; Follicle-Stimulation Hormone less than 10 mIU/mL; Normal infectious tests ( HBS Ag, HIV, VDRL,....)
Exclusion criteria: History of any type of immunotherapy in the medical record; Thin endometrium; Organic diseases of the endometrium; Hydrosalpinx endometriosis stage 3 or 4; Asherman syndrome; Chromosomal disorders of couples; Immune system diseases including rheumatoid arthritis and thyroid autoimmunity during the last three months
Intervention groups
En The intervention group will receive one exosome unit equal to 200 μg of protein intraovarian. Exosomes are derived from umbilical cord mesenchymal stem cells. There is no control group.
Main outcome variables
Fever and chills
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N232
Registration date:2024-11-19, 1403/08/29
Registration timing:registered_while_recruiting
Last update:2024-11-19, 1403/08/29
Update count:0
Registration date
2024-11-19, 1403/08/29
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
2024-10-06, 1403/07/15
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the efficacy of exosomes derived from umbilical cord mesenchymal stem cells in treating infertility in women with chemotherapy-induced ovarian failure
Public title
The effect of exosomes derived from umbilical cord stem cells on infertility in women with ovarian failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
informed consent
Women with POI undergoing chemotherapy
FSH less than 10 mIU/mL
Normal infectious tests (VDRL, HCV, HBS Ag, HIV)
Exclusion criteria:
History of any type of immunotherapy in the medical record
Thin endometrium
Organic diseases of the endometrium
Hydrosalpinx endometriosis stage 3 or 4
Asherman syndrome
Chromosomal disorders of couples
Immune system diseases including rheumatoid arthritis and thyroid autoimmunity during the last three months
Age
No age limit
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
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.1403.199
Health conditions studied
1
Description of health condition studied
Premature ovarian failure
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Fever and chills
Timepoint
End of study
Method of measurement
Ask the patient
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive one exosome unit equal to 200 μg of protein intraovarian. Exosomes are derived from umbilical cord mesenchymal stem cells. There is no control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Motazadi Hospital
Full name of responsible person
Dr. Sahar Rashidi
Street address
Motazedi Hospital, Ferdowsi Square
City
Kermanshah
Province
Kermanshah
Postal code
6718814474
Phone
+98 83 3724 6351
Email
sadar.rashidi@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 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 4618
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 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
Kerrmanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
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 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 4618
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