Determining the effectiveness of exosome in cesarean scar and the IVF outcome
Design
This randomized clinical trial will be conducted 60 patients, 30 patients in case and 30 in control group . For randomization, 30 "A" labels and 30 "B" labels will be 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.
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. 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
Patients with niche who are candidate for lVF.
Inclusion criteria: Patients with niche and secondary infertility
Infertile patients with niche and pelvic pain
Infertile patients with niche and AUB
Having good quality embryos
Exclusion criteria: Patients who are not candidate for laparoscopic surgery
Intervention groups
At the operation room of Yas Hospital a randomized, double -blinded, placebo controlled ,clinical trial with a case group (exosomes injection) and control group (sterile water injection ) will be conducted and patients randomly allocated. The patients, physician, and data analysts will be blinded regarding groups.
Main outcome variables
Biochemical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N46
Registration date:2024-08-17, 1403/05/27
Registration timing:prospective
Last update:2024-08-17, 1403/05/27
Update count:0
Registration date
2024-08-17, 1403/05/27
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
recruiting
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-09-23, 1404/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of injecting exosomes into cesarean scar in women with repeat caesarean section at the IVFoutcome
Public title
Exosome and IVF outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of cesarean scar defect
Secondary infertility
Abnormal uterine bleeding
Exclusion criteria:
Patients who are not candidate for laparoscopic surgery
Having good quality embryos
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
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 (investigator's opinion)
Double 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
1936893813
Approval date
2024-08-12, 1403/05/22
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.204
Health conditions studied
1
Description of health condition studied
Laparoscopic repair of niche and IVF outcome
ICD-10 code
034.21
ICD-10 code description
Maternal care for scar from previous cesarean delivery
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
Four weeks after embryo transfer
Method of measurement
Measurement of blood Bhcg
2
Description
Clinical pregnancy
Timepoint
Six weeks after embryo transfer
Method of measurement
Fetal heart activity in transvaginal sonogram
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: During laparoscopic repair cesarean scar will be resected then uterine incision will be repaired by vicryl 1and exosomes injected.After three months embryo transfer was done.
Category
Treatment - Surgery
2
Description
Control group: During laparoscopic repair cesarean scar will be resected then uterine incision will be repaired by vicryl 1and sterile water injected.After three months embryo transfer was done.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Fatemeh Davari Tanha
Street address
North Nejatollahi Avenue, Karim khan Zand Bridge, 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
Deputy of Research, sixth floor of central building of Tehran University of medical sciences, Ghods Avenue, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 8895 3003
Email
Info@ams.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
North Nejatollahi Avenue, Karim khan Zand Bridge, Villa Street
City
Tehran
Province
Tehran
Postal code
1597856511
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
North Nejatollahi Avenue, Karim khan Zand Bridge, Villa Street
City
Tehran
Province
Tehran
Postal code
1597856511
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, Villa Street
City
Tehran
Province
Tehran
Postal code
1597856511
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
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
Title and more details about the data/document
All data is potentially shareable 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 to Fatedavtanha@gmail.com
What processes are involved for a request to access data/document
Any request must be made to in writing and accompanied by a proposal with an ethics code under supervision of Dr,Davari.