Protocol summary
-
Study aim
-
The production of exosome for treatment of ovarian failure in females treated with chemotherapy drugs or radiotherapy
-
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 or radiothrapy; Follicle-Stimulation Hormone less more 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
-
Mistake in data entry
Adding patients undergoing radiothrapy
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20130812014333N232
Registration date:
2024-11-19, 1403/08/29
Registration timing:
registered_while_recruiting
Last update:
2026-05-28, 1405/03/07
Update count:
2
-
Registration date
-
2024-11-19, 1403/08/29
-
Registrant information
-
-
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 or radiothrapy-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 or radiothrapy
FSH more 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:
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
-
Ethics committees
1
-
Ethics committee
-
-
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
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
1
-
Sponsor
-
-
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
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
-
There is no further information
-
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
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available