The effectiveness of injecting exosomes into cesarean scar in women with ectopic caesarean scar pregnancy at the time of laparoscopic surgery of niche
Design
This is a randomized triple-blind 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 responsible for evaluating the outcomes, the patients, and the data analyst are be blinded to groups assignments.
Settings and conduct
This randomized, clinical trial with a case group ( exosomes injection ) and a control group ( salin injection ) will be conducted at the IVF clinic of Yas Hospital. The patients, physicians evaluating the outcomes, and data analysts will be blinded to the group assignments.
Participants/Inclusion and exclusion criteria
This survey will be conducted on 60 patients with cesarean scar ectopic pregnancy.
Inclusion critria: patients with cesarean scar pregnancy < 14 weeks
Exclusion criteria: patients with chronic underlying disease
Intervention groups
Intervention group: During laparoscopy product of conception will be extracted and scar resected and repaired, then exosomes injected in the site of scar.
Main outcome variables
Measuerments of length and width of the scar site by vaginal sonogram after 6 weeks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N38
Registration date:2024-03-28, 1403/01/09
Registration timing:registered_while_recruiting
Last update:2024-03-28, 1403/01/09
Update count:0
Registration date
2024-03-28, 1403/01/09
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
2024-03-17, 1402/12/27
Expected recruitment end date
2025-03-17, 1403/12/27
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 ectopic caesarean scar pregnancy at the time of laparoscopic surgery
Public title
The effect of exosomes in cesarean scar pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cesarean scar pregnancy who are candidate for laparoscopy
Having signed informed consent
Exclusion criteria:
Gestational age <15 weeks
Age
From 20 years old to 45 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 ( no injection ) are determined by lottery.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients and physcian are blinded regarding the groups, and analyzer only sees the codes in data sheet and is blinded regarding the 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
Research deputy, fifth floor of central building of Tehran University of medical sciences, Ghods Avenue, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.716
Health conditions studied
1
Description of health condition studied
Ectopic cesarean scar pregnancy
ICD-10 code
O00.9
ICD-10 code description
Ectopic pregnancy, unspecified
Primary outcomes
1
Description
Transvaginal sonography for evaluation of the niche site
Timepoint
Six weeks post operation
Method of measurement
Transvaginal sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: During laparoscopy product of conception will be extracted, scar resected and repaired, then exosomes injected in the site of scar.
Category
Treatment - Other
2
Description
Control group: During laparoscopy product of conception will be extracted, scar resected and repaired, then normal saline injected.
Category
Treatment - Other
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, Karimkhan zand bridge, Villa street
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
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 8864 5513
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
15798718311
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
SPSS data of main outcome
When the data will become available and for how long
After publishing article
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Academic researchers for scientific reasons
From where data/document is obtainable
By email to Fatedavtanha@gmail.com
What processes are involved for a request to access data/document