Analysis the effect of embryo transfer with its culture medium on the rate of implantationmedia
Design
Have control group, Non-randomized specificity, parallel groups and Not blinded With 25 people in control group and 25 people in target group. The allocation of individuals in groups is voluntary. Therefore, people who are want to participate in this study with written consent will be placed in the first group and their embryos will be transfer with the around embryo culture media. In the control group, the embryos will be routinely transmit.
Settings and conduct
In this study, after in-vitro fertilization and embryo culture within droplets of the medium, embryo transfer(ET) was performed in two groups with two different methods. in the first group ET with the surrounding culture medium(15 micro-liter) and the other without embryo culture medium (routine ET ). then rate of implantation in the groups evaluated.
Participants/Inclusion and exclusion criteria
inclusion Criteria:
Age 18 to 35 years, tubal factor infertility, 20<BMI<28
exclusion criteria:
Severe endometriosis, Hydrosalopinx, Hormonal disorders, severe poly cystic ovary (PCO), Acute pelvic infections, uterus anatomical abnormalities
Intervention groups
the first group, embryo transfer with its culture medium that developed in it
The control group, perform embryo transfer with routine manner, after the transfer of the embryo to the fresh environment in the transfer plate.
Main outcome variables
implantation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180630040286N1
Registration date:2019-03-13, 1397/12/22
Registration timing:registered_while_recruiting
Last update:2019-03-13, 1397/12/22
Update count:0
Registration date
2019-03-13, 1397/12/22
Registrant information
Name
Sadeq Eivazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3671 0429
Email address
eyvazi.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analysis the effect of embryo transfer with its culture medium on the rate of implantation
Public title
Analysis the effect of embryo transfer with its culture medium on the rate of implantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
tubal factor infertility
BMI between 20-28
age between 18-35 years old
Exclusion criteria:
Severe endometriosis
Hydrosalpinx
Hormonal disorders
Severe PCO
Acute pelvic infections
Uterus anatomical abnormalities
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Not randomized
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
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-08-26, 1397/06/04
Ethics committee reference number
IR.IUMS.REC.1397.260
Health conditions studied
1
Description of health condition studied
Embryo implantation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
embryo implantation
Timepoint
At the beginning of the study and 14 days after the embryo transfer
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Women whose embryo transfer together with the environment culture mediom around the embryo
Category
Treatment - Other
2
Description
Control group: Women whose embryo transfer performed with routine method, after the transfer of embryo to the transmission medium.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abadi Hospital
Full name of responsible person
Fatemeh sadat Amjadi
Street address
Mowlavi St, Shahid Akbarabadi Hospital
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5560 6034
Email
sadeq.eivazi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. seyed kazem malakouti
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
reaserch@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Tayebeh Artimani
Street address
Daneshgah-e-Bu Ali Sina, Hamedan, Hamadan Province
City
Hamedan
Province
Hamadan
Postal code
6517619654
Phone
+98 81 3252 0182
Email
ICT@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
50
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
Iran University of Medical Sciences
Full name of responsible person
Sadeq Eivazi
Position
Phd student
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
Email
sadeq.eivazi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sadeq Eivazi
Position
Phd student
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
Email
sadeq.eivazi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sadeq Eivazi
Position
Phd student
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
Email
sadeq.eivazi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Not more info
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
publishing article
When the data will become available and for how long
After publish the article
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to treat people with infertility
From where data/document is obtainable
Through information databases
What processes are involved for a request to access data/document
The data will be available only after the article publication