Comparing the effect of intrauterine injection of platelet-rich plasma on pregnancy outcome in IVF candidate women with recurrent implantation failure and thin endometrium
Comparing the effect of intrauterine injection of platelet-rich plasma on pregnancy outcome in IVF candidate women with recurrent implantation failure and thin endometrium
Design
This controlled, parallel-group, nonblinded, phase 3 clinical trial is conducted on 90 women with recurrent implantation failure and thin endometrium and candidates for IVF.
Settings and conduct
This study is conducted on women who have been referred to Yas Hospital for their IVF and have a history of recurrent implantation failure and thin endometrium. In the intervention group, 24 to 48 hours before embryo transfer, 5 cc of platelet-rich plasma is poured into the uterus using an intrauterine sperm injection (IUI) catheter. However, in the control group, no extra intervention is done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 20 to 38, with body mass index below 30, having A or B fetuses and endometrial thickness less than 7 mm despite receiving hormonal treatment, as well as a history of IVF failure. Exclusion criteria: patients with a history of underlying disease or uterine disorders.
Intervention groups
In the intervention group, 24 to 48 hours before the embryo transfer, 5 cc of platelet-rich plasma is poured into the uterus using an intrauterine insemination (IUI) catheter. In the control group: Before the embryo transfer, no extra intervention is performed for the patient.
Main outcome variables
Clinical pregnancy is checked once, six weeks after embryo transfer.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240119060732N1
Registration date:2024-01-28, 1402/11/08
Registration timing:prospective
Last update:2024-01-28, 1402/11/08
Update count:0
Registration date
2024-01-28, 1402/11/08
Registrant information
Name
Firoozeh Akbari Asbagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4216 0852
Email address
fasbagh_md@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-29, 1402/12/10
Expected recruitment end date
2025-02-28, 1403/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of intrauterine injection of platelet-rich plasma on pregnancy outcome in IVF candidate women with recurrent implantation failure and thin endometrium
Public title
Effect of intrauterine injection of platelet-rich plasma on pregnancy outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 38 years
Body mass index below 30
Patients with embryo quality A or B
Endometrial thickness less than 7 mm despite receiving hormonal treatment
With a history of IVF failure
Exclusion criteria:
Patients with diabetes
Use of immune system suppressing drugs
Patients with malignancy
Uterine myomatosis or adenomyosis or hydrosalpingus
Endometriosis stage 4
The presence of acute pelvic infection
The presence of blood or platelet disorders
Age
From 20 years old to 38 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
N/A
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
The ethic commitee of Tehran University of Medical sciences
Street address
Ethics committee of Tehran University of Medical Sciences, School of Medicine, Tehran Province, Tehran, Pour Sina St" to "Tehran University of Medical Sciences, School of Medicine, Pour Sina St., Qods St., Kesahvarz Blvd.
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2023-09-30, 1402/07/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.364
Health conditions studied
1
Description of health condition studied
Female infertility of uterine origin
ICD-10 code
N97.2
ICD-10 code description
Female infertility of uterine origin
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
Once, six weeks after fetal transfer
Method of measurement
Ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 24 to 48 hours before the embryo transfer, 5 cc of platelet-rich plasma, which is prepared from the person's peripheral blood, is poured into the uterus using an intrauterine insemination (IUI) catheter.
Category
Treatment - Drugs
2
Description
Control group: Before the embryo transfer, no extra intervention is performed for the patient and the patient returns on the day of the embryo transfer.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Firoozeh Akbari Asbagh
Street address
Yas hospital, Next to the Sarv St., North Nejatollahi St., Karimkhan Ave.
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
fasbagh_md@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Dean of Research of Tehran University of Medical Sciences, Dr. Ali Akbari Sari
Street address
Vice-Dean of Research, Tehran University of Medical Sciences, Floor 6, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 8163 3698
Email
vcr@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
Firoozeh Akbari Asbagh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the Sarv St., North Nejatollahi St., Karimkhan Ave.
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 4216 0852
Fax
Email
fasbagh_md@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Firoozeh Akbari Asbagh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the Sarv St., North Nejatollahi St., Karimkhan Ave.
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 4216 0852
Fax
Email
fasbagh_md@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Firoozeh Akbari Asbagh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the Sarv St., North Nejatollahi St., Karimkhan Ave.
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 4216 0852
Fax
Email
fasbagh_md@yahoo.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
Not applicable
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
Not applicable
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 the manuscript is published.
To whom data/document is available
No limitations.
Under which criteria data/document could be used
The data is only available to the project manager, Dr. Firoozeh Akbari Asbagh, and any analysis must be done with her opinion.
From where data/document is obtainable
The data is only available to the project manager, Dr. Firoozeh Akbari Asbagh, and any analysis must be done with her opinion.
What processes are involved for a request to access data/document
Any request must be sent by e-mail with its proposal to Dr. Firoozeh Akbari Asbagh.