Investigating the effect of intrauterine exosome injection on pregnancy outcomes in infertile women candidates for IVF and repeated implantation failure
Evaluation of pregnancy rate in recurrent implantation failure after injection of exosomes via intrauterine route
Design
A clinical trial, with 30 patients who are allocated in study. This is phase 3 trial that previous cycle is supposed as control group.
Settings and conduct
At IVF clinic of Yas hospital this trial with case (Intra uterine infusion exosome at 8th day of esterogen replacement) and control (previous cycle of each patient ) groups will be conducted.
Participants/Inclusion and exclusion criteria
Thirty patients with history of RIF who have good quality embryos, age 20-37 y/o
Exclusion criteria: absence of uterine abnormalities or adhesion, will be included in study.
Intervention groups
Intervention group: After eight days of estrogen therapy, exosomes will be injected into uterine cavity by IUI (intra uterine insemination) catheter, for recurrent implantation failure.
Control group: The previous cycle of each patient is as control group .
Main outcome variables
Chemical and clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N44
Registration date:2024-06-23, 1403/04/03
Registration timing:prospective
Last update:2024-06-23, 1403/04/03
Update count:0
Registration date
2024-06-23, 1403/04/03
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
2024-07-05, 1403/04/15
Expected recruitment end date
2025-03-30, 1404/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of intrauterine exosome injection on pregnancy outcomes in infertile women candidates for IVF and repeated implantation failure
Public title
The effect of exosomes on recurrent implantation failure (RIF)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of recurrent implantation failure due to unknown etiology
Having good quality mbryo
age 20-37y
Exclusion criteria:
Uterine malformations
Asherman syndrome
Liver diseas
Severe male infertility
Body mass index(BMI)>30
Uncontrolled hypothyroidism
Age
From 20 years old to 37 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethic committee of Tehran University of medical sciences
Street address
Deputy of Research, fifth floor of central building of Tehran University of medical sciences, Ghods Avenue, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-06-02, 1403/03/13
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.113
Health conditions studied
1
Description of health condition studied
Recurrent implantation failure
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Endometrial thickness and quality
Timepoint
Two days after intervention
Method of measurement
Transvaginal sonogram
Secondary outcomes
1
Description
Chemical 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
Transvaginal sonogram
Intervention groups
1
Description
Intervention group: After eight days of estrogen 6 mg daily, exosomes 100 micro liter will be injected into uterine cavity by IUI catheter, for RIF.
Category
Treatment - Drugs
2
Description
Control group: The previous cycle of each patient is as control group .
Category
Treatment - Drugs
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, Karim khan Zand Bridge
City
Tehran
Province
Tehran
Postal code
1598718311
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
Fifth floor of central building of Tehran University of medical sciences, Ghods Avenue, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3102
Email
rmo@tums.ac.ir
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, Karim khan Zand Bridge
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, Karim khan Zand Bridge
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, Karim khan Zand Bridge
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
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially sharable after unidentified participants.
When the data will become available and for how long
After manuscript published
To whom data/document is available
The data is available to the project manager, Dr.Davari and any analysis must be done with her permission.
Under which criteria data/document could be used
No limitation.
From where data/document is obtainable
Dr.Davari through email (fdavaritanha@sina.tums.ac.ir)
What processes are involved for a request to access data/document
Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Davari.