Comparative study of the effect of intra-uterine PRP injection on endometrial thickness and pregnancy result in women with recurrent implantation failure or thin endometrium under and over 35 years old undergoing freeze-thawed embryo transfer
Comparison of the effect of intra-uterine PRP injection on endometrial thickness and pregnancy result in women with recurrent implantation failure or thin endometrium under and over 35 years old undergoing freeze-thawed embryo transfer
Design
Phase 3 clinical trial with a control group will be conducted in parallel groups on 62 patients. Randomization of the samples will be done with a simple randomization method according to the generated list. The list of random numbers will be generated by a statistical consultant using Random Allocation1 software. 31 patients will be in the intervention group and 31 patients will be in the control group.
Settings and conduct
The clinical trial will be conducted in Semnan Amiralmomenin hospital. The study and control cases will be selected among patients referring to the infertility clinic who are candidates for freeze-thawed embryo transfer who suffer from recurrent implantation failure or thin endometrium despite of hormone replacement. In intervention group PRP will be done. In control group PRP will not be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women under 40 years old with recurrent implantation failure or thin endometrium who are candidate of freeze-thawed embryo transfer
Intervention groups
Both groups will be selected from infertile women candidate for freeze-thawed embryo transfer who suffer from recurrent implantation failure or thin endometrium despite of hormone replacement. In intervention group PRP will be done. In control group PRP will not be done.
Main outcome variables
Clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231119060109N1
Registration date:2023-12-05, 1402/09/14
Registration timing:prospective
Last update:2023-12-05, 1402/09/14
Update count:0
Registration date
2023-12-05, 1402/09/14
Registrant information
Name
Sahereh Arabian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
s.arabian@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of intra-uterine PRP injection on endometrial thickness and pregnancy result in women with recurrent implantation failure or thin endometrium under and over 35 years old undergoing freeze-thawed embryo transfer
Public title
Effect of intra-uterine PRP injection on endometrial thickness and pregnancy result in women with recurrent implantation failure or thin endometrium under and over 35 years old undergoing freeze-thawed embryo transfer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with recurrent implantation failure undergoing freeze-thawed embryo transfer
Women with endometrial thickness of under 7mm on 13th day of hormone replacement cycle of freeze-thawed embryo transfer
Women under 40 years old
Exclusion criteria:
Age over 40 years
Age
To 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization list of samples in groups will be generated using Random Allocation1 software. Then, according to the order of patient's referral and taking into account the criteria for entering the study, according to the patient's entry number from the list, the study group is announced to the researcher by the statistical consultant, and on each sample according to the study group , the intervention is done or they are placed in the control group
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
Ethics committee of Semnan University of Medical Sciences
Street address
Basij Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2023-10-30, 1402/08/08
Ethics committee reference number
IR.SEMUMS.REC.1402.171
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
Observation of fetal heart activity by transvaginal ultrasonography
Secondary outcomes
1
Description
Chemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
Through blood sample for Beta Hcg
Intervention groups
1
Description
Intervention group: infertile women candidate for freeze-thawed embryo transfer who suffer from recurrent implantation failure or thin endometrium despite of hormone replacement. In intervention group PRP will be done.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Nahid Azad
Street address
Mostafa Khomeini Blvd., Imam Hossein .,Semnan
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
amir.hospital@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
majidmir@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Nahid Azad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Mostafa Khomeini Blvd., Imam Hossein .,Semnan
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
nazad1390@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nahid Azad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Mostafa Khomeini Blvd., Imam Hossein .,Semnan
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
nazad1390@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nahid Azad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Mostafa Khomeini Blvd., Imam Hossein .,Semnan
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
nazad1390@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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 participants data sets are to be shared.
When the data will become available and for how long
2 months after publication of results.
To whom data/document is available
Researchers of academic centers
Under which criteria data/document could be used
To evaluate the accuracy of data and to use them to complete other researches
From where data/document is obtainable
Submit your request by sending an email.
What processes are involved for a request to access data/document
By sending an e-mail, by reviewing the request and providing documentation and the reason for using the data, it will be provided within a week.