Comparison of endometrial thickness in freeze embryo transfer (ET) with and without the use of gonadotropin-releasing hormone (GnRH) with taking estradiol
Comparison of endometrial thickness in freeze embryo transfer (ET) with and without the use of gonadotropin-releasing hormone (GnRH) with taking estradiol
Design
This is a nonblinded clinical trial. The study population includes all infertile women who are candidates for embryo transfer and refer to Motazedi hospital of Kermanshah city during 2016-2018.65 eligible patients will be selected conveniently and randomly assigned to tow intervention and control groups.
Settings and conduct
This study, which will be conducted in Motazadi hospital of Kermanshah city, is nonblinded one. The infertile female who candidate for embryo transfer will be examined according to the treatment procedures of the center during the embryo transfer period. If embryo transfer does not result in pregnancy for any reason, then in the next cycle, will be treated with estradiol and GnRH-a pills.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Less than or equal to 42 years old;
The FSH level is less than 10 ml/mIU
Exclusion criteria:Patients with asthma, systemic diseases and digestive disorders
Intervention groups
The intervention group, in addition to the estradiol tablet, will receive an antagonist gonadotropin-releasing hormone in 0.1 mg injection(manufactured by Iran Hormones Inc).
The control group will receive the estradiol tablet in packages of 21 one (manufactured by Iran).
Main outcome variables
Rate of fertile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N104
Registration date:2018-10-07, 1397/07/15
Registration timing:prospective
Last update:2018-10-07, 1397/07/15
Update count:0
Registration date
2018-10-07, 1397/07/15
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-17, 1397/07/25
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of endometrial thickness in freeze embryo transfer (ET) with and without the use of gonadotropin-releasing hormone (GnRH) with taking estradiol
Public title
Comparison of endometrial thickness in freeze embryo transfer (ET) with the use of gonadotropin-releasing hormone (GnRH-a) agonists
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Less than or equal to 42 years old
The FSH level is less than 10 ml/mIU
Exclusion criteria:
Patients with asthma, systemic diseases and digestive disorders
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt.In this way, cards are matched in appearance, 65of which are code 1 identifying the intervention group, and 65of them are code 2, which specifies the control group. Then, each participant randomly selects one of these cards.
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-06-13, 1397/03/23
Ethics committee reference number
ir.kums.rec.1397.137
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Rate of fertile
Timepoint
The beginning and end of the study
Method of measurement
Using Ultrasound machine
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group, in addition to the estradiol tablet, will receive an antagonist gonadotropin-releasing hormone in 0.1 mg injection(manufactured by Iran Hormones Inc).
Category
Treatment - Drugs
2
Description
The control group will receive the estradiol tablet in packages of 21 one (manufactured by Iran).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motazedi
Full name of responsible person
Marayam Fassihi
Street address
Ferdowsi Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3424 6351
Email
Drfassihi92@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Fassihi
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 34276309
Email
Drfassihi92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Taravat Fakheri
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 34276309
Email
Fakheritaravats@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Fassihi
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 34276309
Email
Drfassihi92@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
The main outcomes of the study will be shared.
When the data will become available and for how long
4 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail