Evaluation of the effect of the autologous exosomes derived from menstrual blood mesenchymal stem cells on implantation rate and prevention of miscarriage in patients with recurrent implantation failure
Evaluation of the effect of the autologous exosomes derived from menstrual blood mesenchymal stem cells on implantation rate and prevention of miscarriage in patients with recurrent implantation failure
Design
Phase 1 and 2 randomized clinical trials with 22 patients in each group
Settings and conduct
This study will be performed in the infertility department of Imam Khomeini Hospital, Sari, Iran. The menstrual blood of patients with recurrent implantation failure is collected with a menstrual cup. Then the mesenchymal stem cells of the menstrual blood and the secreted exosomes are isolated and identified. Finally, autologous exosomes are injected into the uterus of patients in the intervention group with anIntrauterine insemination (IUI) catheter.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with recurrent implantation failure who have a history of at least three failures in the embryo transfer cycle or did not conceive after transferring at least ten good-quality embryos are studied. Patients should have a body mass index below 30 kg/m2 and be in the age range of 20-40 years.
Exclusion criteria: uterine abnormality in hysteroscopy, blood disorders, immunological disorders, hormonal disorders, and genetic abnormalities in parents.
Intervention groups
Forty-four patients who meet the inclusion criteria are divided into intervention and control groups. In the intervention group, 48 hours before frozen embryo transfer, 2 ml of exosomes derived from mesenchymal cells of menstrual blood are injected into the uterus with an IUI catheter. In the control group, exosome injection is not performed before frozen embryo transfer.
Main outcome variables
Clinical pregnancy rate, Chemical pregnancy rate, Implantation rate, Live birth rate, Abortion rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210228050535N2
Registration date:2023-01-03, 1401/10/13
Registration timing:prospective
Last update:2023-01-03, 1401/10/13
Update count:0
Registration date
2023-01-03, 1401/10/13
Registrant information
Name
Amirali Khodashenas limoni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3353
Email address
s.khodashenas@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of the autologous exosomes derived from menstrual blood mesenchymal stem cells on implantation rate and prevention of miscarriage in patients with recurrent implantation failure
Public title
Exosome therapy in recurrent implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with recurrent implantation failure who did not conceive after at least three embryo transfer cycles or after transferring at least ten good-quality embryos.
Age between 20–40 years
With Body Mass Index (BMI) under 30 kg/m2
Exclusion criteria:
Uterine abnormalities in hysteroscopy and hysterosalpingography
Hematologic disorders
Hormonal disorders
Immunologic disorders
Chromosomal abnormalities and genetic disorders in parents
Age
From 20 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
A random series of 44 is generated for patients who meet the study inclusion criteria. Patients are divided into intervention and control groups with a 1:1 ratio, so twenty-two patients are assigned to each group. Block randomization is performed by https://www.sealedenvelope.com with blocks of size 4.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Hospital-Mazandaran University of Medical Sciences
Street address
Amir Mazandarani St
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2022-12-14, 1401/09/23
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1401.048
Health conditions studied
1
Description of health condition studied
Recurrent implantation failure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Chemical pregnancy rate
Timepoint
Two weeks after embryo transfer
Method of measurement
Measurement of B-HCG
2
Description
Clinical pregnancy rate
Timepoint
Five weeks after embryo transfer
Method of measurement
Sonography
3
Description
Abortion rate
Timepoint
During pregnancy
Method of measurement
Sonography
Secondary outcomes
1
Description
Live birth rate
Timepoint
End of pregnancy
Method of measurement
Parturition
2
Description
Implantation rate
Timepoint
Six weeks after embryo transfer
Method of measurement
The number of gestational sacs divided by the number of transferred embryos
3
Description
Ongoing pregnancy
Timepoint
20th week of pregnancy
Method of measurement
Sonography
Intervention groups
1
Description
Intervention group: Fourty-eight hours before the transfer of frozen embryos 2 ml of autologous exosomes derived from menstrual blood mesenchymal cells with a total protein of 20 μg/μl are injected into the uterus of patients in the intervention group through the IUI catheter.
Category
Treatment - Drugs
2
Description
Control group: Transfer of frozen embryos is performed without injection of autologous exosomes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Imam Hospital
Full name of responsible person
Sepideh Peyvandi
Street address
Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3434 3432
Email
dr_peyvandi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram ebrahimnejad
Street address
University of Medical sciences Moallem square,Sari.Iran.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3325 7230
Email
pajhoheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Shabanali Khodashenas
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Department of Medical Biotechnology, Faculty of Advanced Medical Sciences, Payambar Azam Camplex
City
Sari
Province
Mazandaran
Postal code
4816934561
Phone
+98 11 3311 8945
Email
s.khodashenas@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Shabanali Khodashenas
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Department of Medical Biotechnology, Faculty of Advanced Medical Sciences, Payambar Azam Camplex
City
Sari
Province
Mazandaran
Postal code
4816934561
Phone
+98 11 3311 8945
Email
s.khodashenas@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh zare taji
Position
Master's student
Latest degree
Master
Other areas of specialty/work
Medical Biotechnology
Street address
Department of Medical Biotechnology, Faculty of Advanced Medical Sciences, Payambar Azam Camplex
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3354 3353
Fax
Email
f.zare.zt@gmail.com
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