IRCT | The effectiveness of injecting mesenchymal cell-derived exosomes into cesarean scar in women with repeat caesarean section at the time of laparoscopic cesarean niche repair.

Protocol summary

Study aim: The effectiveness of exosomes into cesarean scar at the time of laparoscopic niche repair.
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.
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 laparoscopic repair. Inclusion critria: Patients with niche and infertility,Patients with niche and pelvic pain,Patients with niche and AUB,Patients with niche and recurrent implantation failure Exclusion criteria: Patients who are not candidate for laparoscopic surgery
Intervention groups: 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.
Main outcome variables: Evaluation of niche by transvaginal sonogram.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20091012002576N36

Registration date: 2024-02-24, 1402/12/05

Registration timing: prospective

Last update: 2024-02-24, 1402/12/05

Update count: 0
Registration date: 2024-02-24, 1402/12/05

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: 2024-03-20, 1403/01/01
Expected recruitment end date: 2025-03-21, 1404/01/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effectiveness of injecting mesenchymal cell-derived exosomes into cesarean scar in women with repeat caesarean section at the time of laparoscopic cesarean niche repair.

Public title: Evaluation exosomes on niche
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Patients with niche and infertility Patients with niche and pelvic pain Patients with niche and AUB Patients with niche and recurrent implantation failure

Exclusion criteria:

Patients who are not candidate for laparoscopic surgery
Age: From 20 years old to 50 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.

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

1597815978
Approval date: 2024-02-20, 1402/12/01
Ethics committee reference number: IR.TUMS.MEDICINE.REC.1402.6

Health conditions studied

1

Description of health condition studied: Laparoscopic repair of niche
ICD-10 code: O34.21
ICD-10 code description: Maternal care for scar from previous cesarean delivery

Primary outcomes

1

Description: Evaluation of niche by transvaginal sonogram
Timepoint: Six weeks after surgery
Method of measurement: Transvaginal sonogram

2

Description: AUB, pelvic pain
Timepoint: Sixth weeks after surgery
Method of measurement: Patient History

3

Description: Infertility
Timepoint: Two months after surgery
Method of measurement: BhCG blood test

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.
Category: Treatment - Surgery

2

Description: Control group: During laparoscopy ,uterine incision will be resected and repaired by vicryl 1and strile water injected in the site of scar.
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

1597815978

Phone

+98 21 8880 0115

Email

Fatedavtanha@gmail.com

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

1597815978

Phone

+98 21 8864 5514

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

1597815978

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

1597815978

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

1597815978

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 file
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: ‌Related scientific analysis
From where data/document is obtainable: Mail to Fatedavtanha@gmail.com
What processes are involved for a request to access data/document: Formal request
Comments

The effectiveness of injecting mesenchymal cell-derived exosomes into cesarean scar in women with repeat caesarean section at the time of laparoscopic cesarean niche repair.