Evaluation the efficacy of subendometrial PRP injection on implantation
Design
Randomized double blind clinical trial, with 30 patients who are allocated in each parallel group, This is phase 3 trial that patient and physician (who is different from surgeon that perform procedure) will evaluate the outcome will be blinded regarding groups.
Settings and conduct
This randomized blinded clinical trial will be conducted in case( hysteroscopy crushing endometrium, PRP) and control (hysteroscopy crushing endometrium) groups at IVF clinic of YAS hospital.
Participants/Inclusion and exclusion criteria
History of recurrent implantation failure
Having good quality embryo
No uterine anomaly
Intervention groups
For 30 patients with history of recurrent implantation failure will be included in the randomized blinded clinical trial for PRP injection to four points at anterior and posterior and lateral wall of subendometrial uterine cavity during luteal phase hysteroscopy and crushing endometrium.
Main outcome variables
Chemical pregnancy, clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N29
Registration date:2023-08-10, 1402/05/19
Registration timing:prospective
Last update:2023-08-10, 1402/05/19
Update count:0
Registration date
2023-08-10, 1402/05/19
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
2023-09-06, 1402/06/15
Expected recruitment end date
2025-03-05, 1403/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of subendometrial PRP injection for FET cycle of RIF patients
Public title
Efficacy of subendometrial PRP injection for FET cycle of RIF patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
RIF patients
Have good quality embryo
Having signed informed consent
Age 20-40 years
Exclusion criteria:
Severe male infertility
BMI>30
Uncontrolled hypothyroidism
User of corticosteroids
User of glucose control agents
CNS tumour
Uterine malformation
Cavity distorting lesions
Severe endometriosis
Liver disease
Asherman syndrome
Age
From 20 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
Randomization rule: First 30 letters A and 30 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patients. In addition, interventions A (case group : hysteroscopycrushingendometrium, subendometrial PRP injection ) or B (control group: hysteroscopy crushing endometrium) are determined by a lot.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient and physician (she in not the same person that perform procedure)who evaluate the outcome are blinded regarding control( hysteroscopy crushing endometrium) or case (hysteroscopy crushing endometrium, PRP) groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of medical sciences
Street address
Fatemeh Saeidi, sixth floor of central building of Tehran University medical sciences, Ghods Avenue, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
15978
Approval date
2023-06-23, 1402/04/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.200
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
Female inf
ICD-10 code description
N97.8
Primary outcomes
1
Description
Endometrial thickness
Timepoint
At the day of start progesterone
Method of measurement
Transvaginal sonogram
2
Description
Chemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
Bhcg titer
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
Cardiac activity four weeks after embryo transfer
Method of measurement
Transvaginal sonogram
Intervention groups
1
Description
"Intervention group": At the time of hysteroscopy in luteal phase under anesthesia, RPP that will be prepared before surgery, injected in subendometrial area of endometrial cavity at four points with needle.
Category
Treatment - Surgery
2
Description
"Control group": At the time of surgery hysteroscopy and crushing endometrium will be performed, in luteal phase under anesthesia,
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas Hospital
Full name of responsible person
Fatemeh Davari Tanha
Street address
IVF ward,Yas hospital, North Nejatollahi Avenue, Karim khan Zand Bridge, Villa Street
City
Tehran
Province
Tehran
Postal code
15978
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
Fatemeh Davari Tanha
Street address
IVf ward,Yas hospital, North Nejatollahi Avenue, Karim khan Bridge,
City
Tehran
Province
Tehran
Postal code
15978
Phone
+98 21 8880 0115
Email
Fatedavtanha@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
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Nejatollahi Avenue, Karim khan Bridge
City
Tehran
Province
Tehran
Postal code
15978
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, Villa Street
City
Tehran
Province
Tehran
Postal code
15978
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
Medical doctor
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
15978
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 the article
To whom data/document is available
To researchers
Under which criteria data/document could be used
Requesting by email
From where data/document is obtainable
From email fatedavtanha@gmail.com
What processes are involved for a request to access data/document