Investigation of the effects of intraovarian exosomes in infertile patients
Design
This is a randomized triple-blind, placebo control, phase 3 clinical trial involving a total of 60 patients; 30 patients in the case group allocated to 30 patients in the control group. For randomization, 30 "A" labels and 30 "B" labels covered in envelopes are placed in a box. For each patient an evelope is drawn out of the box. The physician, the patients, and the data analyst are be blinded to groups assignments.
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Settings and conduct
This randomized, triple-blinded, placebo controlled, clinical trial with a case group ( exosomes injection ) control group ( sterile water injection ) will be conducted at the operation room of Yas Hospital in Tehran. Random allocation will be used regarding case and control groups. The patients, physician, and data analysts will be blinded to the group assignments.
Participants/Inclusion and exclusion criteria
Inclusion critria: 20-45 years old women with history of poor ovarian response in previous cycle.
Exclusion criteria: Male infertility, Ovarian failure due to gonadal dysgenesis
Intervention groups
Intervention group: exosomes will be injected in the ovarian tissue by transvaginal ultrasonographic guidance at the day of oocyte punctuer under anesthesia after three months, ovarian response and function will be evaluated.
Main outcome variables
Ovarian response
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N37
Registration date:2024-03-25, 1403/01/06
Registration timing:prospective
Last update:2024-03-25, 1403/01/06
Update count:0
Registration date
2024-03-25, 1403/01/06
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-04-19, 1403/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of intraovarian injection of exosomes derived from mesenchymal cells in infertile women with poor ovarian response
Public title
Exosomes injection on poor responder ovary
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Abnormal ovarian reserve test
Antral follicle count <5
At least one previous IVF cycle <3 oocyte was retrieved.
Exclusion criteria:
Ovarian insufficiency due to gonadal dysgenesia and abnormality of chromosoms
Male infertility
Age
From 18 years old to 42 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: At first, on special unmarked papers, 30 A letters and 30 B letters are written. Then all (60) are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly without replacement. Based on the letter written on it, the intended intervention is performed on the patient. In addition, interventions A ( exosome injection ) or B ( sterile water injection ) are determined by lottery.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients and physician are blinded regarding the groups, and analyzer only sees the codes in data sheet and is blinded regarding groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of medical sciences
Street address
Sixth floor of central building of Tehran University of medical sciences, Ghods Avenue, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1597856511
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
.IR.TUMS.MEDICINE.REC.1402.717
Health conditions studied
1
Description of health condition studied
Poor ovarian response
ICD-10 code
N97.8
ICD-10 code description
Female infertility of other origin
Primary outcomes
1
Description
AMH
Timepoint
Three months after intervention
Method of measurement
Blood test
2
Description
FSH
Timepoint
Three months after intervention
Method of measurement
Blood test
3
Description
Number of oocyte
Timepoint
Three months after intervention
Method of measurement
Follicle counts in transvaginal sonogram
Secondary outcomes
1
Description
Biochemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
BhCG measurement
2
Description
Clinical pregnancy
Timepoint
Four weeks after embryo transfer
Method of measurement
Fetal heart activity in transvaginal sonogram
Intervention groups
1
Description
Intervention group: exosomes will be injected in the ovarian tissue by transvaginal ultrasonographic guidance at the day of oocyte punctuer under anesthesia after three months, ovarian response and function will be evaluated.
Category
Treatment - Surgery
2
Description
Control group: sterile water will be injected in the ovarian tissue by transvaginal ultrasonographic guidance at the day of oocyte punctuer under anesthesia after three months, ovarian response and function will be evaluated.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Fatemeh Davari Tanha
Street address
Yas hospital, North Nejatollahi Avenue, Villa Street
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Sixth floor of central building of Tehran University of medical sciences, Ghods Avenue, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6644 0000
Email
Herc.tums@gmail.com
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
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Nejatollahi Avenue, Villa Street
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Nejatollahi Avenue, Villa Street
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Nejatollahi Avenue, Villa Street
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
SPSS file
When the data will become available and for how long
Six months after completing the project data will be available.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific analysis
From where data/document is obtainable
Email to Fatedavtanha@gmail.com
What processes are involved for a request to access data/document