Comparing in vitro fertilization outcomes in antagonist protocol triggering within 3 groups of GnRH agonist, hCG, dual ( GnRH and hCG) in infertile women
Comparing in vitro fertilization outcomes in antagonist protocol triggering within 3 groups of GnRH agonist, hCG, dual ( GnRH and hCG) in infertile women
Design
international clinical trial, phase 2-3,108 infertile women in ovulation induction cycle will be randomized based on the randomization table, from www.randomization.org.
Settings and conduct
Patients undergoing IVF at Mother and Child Hospital All will undergo antagonist protocol and are divided into three groups on the day of final ovulation stimulation: group one: 0.2 mg dipherelin, group two: 10000 unit human chorionic gonadotropin unit, The other group in addition to 0.2 mg of dipherelin 1500 units of human chorionic gonadotropin
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-40 years women
infertile women
Follicular stimulating hormone <12U/lit
menstruation interval 25-34 days
Having both ovaries
Exclusion criteria:Endocrine disease, uterine anomaly
Intervention groups
three groups on the day of final ovulation stimulation: one 0.2 mg dipherelin group, one 10000 unit human chorionic gonadotropin unit, one The group in addition to 0.2 mg of dipherelin 1500 units of human chorionic gonadotropin
Main outcome variables
Clinical pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160130026260N2
Registration date:2020-03-23, 1399/01/04
Registration timing:registered_while_recruiting
Last update:2020-03-23, 1399/01/04
Update count:0
Registration date
2020-03-23, 1399/01/04
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 2365
Email address
shaghayeghmoradi84@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-11, 1398/12/21
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing in vitro fertilization outcomes in antagonist protocol triggering within 3 groups of GnRH agonist, hCG, dual ( GnRH and hCG) in infertile women
Public title
In vitro fertilization outcome triggered with different dosage of GnRH and hCG in antagonist protocol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-40 years women
Follicular stimulating hormone lower than 12U/lit
menstruation interval 25-34days
Having both ovaries
infertile women
Exclusion criteria:
Endocrine disease
uterine anomaly
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization:patients in ovulation induction cycle will be randomized based on the randomization table, from www.randomization.org.
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 Shiraz University of Medical Science
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2015-06-09, 1394/03/19
Ethics committee reference number
IR.SUMS.med.REC.1394.27
Health conditions studied
1
Description of health condition studied
infertility patients going ivf
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
2 months after embryo transfer
Method of measurement
Ultrasonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Administration of 0.2 mg Dipherellin on the triggering day of ovulation
Category
Treatment - Drugs
2
Description
Intervention group: Administration of 0.2 mg Dipherellin and 1500 unit HCG on the triggering day of ovulation
Category
Treatment - Drugs
3
Description
Intervention group: Administration of 10000 unit HCG on the triggering day of ovulation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghadir Mother and Child Hospital
Full name of responsible person
Shaghayegh Moradi Alamdarloo
Street address
Before Quran Gate, Golshan town
City
Shiraz
Province
Fars
Postal code
7134544119
Phone
+98 71 3233 2365
Email
shaghayeghmordi84@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
71348 -44119
Phone
+98 71 3230 5410
Email
sacrc@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Shaghayegh Moradi Alamdarloo
Position
Gynecologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Obstetrics department , Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3233 2365
Email
shaghayeghmoradi84@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Alamtaj Samsami Dehaghani
Position
Infertility fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Obstetrics department , Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3233 2365
Email
samsamia@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shaghayegh Moradi Alamdarloo
Position
gynecologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Obstetrics department , Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3233 2365
Email
shaghayeghmoradi84@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Hormonal data, ovarian stimulation data, embryo transfer data, pregnancy outcome
When the data will become available and for how long
6 month after acceptance of paper
To whom data/document is available
People who want to do work in this area and have scientific documentation can
Under which criteria data/document could be used
Valid Scientific Persons By Presenting Relevant Documents
From where data/document is obtainable
An email to corresponding author
What processes are involved for a request to access data/document
Accepting permission from the Shiraz University of Medical Sciences's security and confirming the receipt of the file