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Comparison of IVF outcome in antagonist cycles by using different dosages of GnRH agonist (0.1, 0.2, and 0.3 diphereline) in triggering of final oocyte maturation in infertile women referring to Mother & Child hospital in 2014&2015

Protocol summary

Study aim
Comparison the effect of antagonist cycles by of different of GNRH agonist (.1,.2,.3) dipherline for triggeing of final oocyte maturation in infertile women on fertilization rate , implantation rate, OHSS in cided. The number and quality of oocyte retried, number of m2 oocyte, number and quality of the emberyos
Design
In this research , 150 patients referred to Ghadir Shiraz Maternal and Child Infertility Center were selected for inclusion in the study. Participants were randomly divided into three groups, with intervention for each of the three groups, each receiving a unique number.
Settings and conduct
Patients were randomly divided into three groups: the first group received 1.1 mg, the second group 2.2 mg and the third group received 3.3 mg of dipherelin after proper follicular growth. In all subjects, the amount of drug used, FSH and AMH levels, and estradiol and LH levels were measured daily. And this study is done in Shiraz Maternal and Child Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with aged between 20-40 years; Women with baseline FSH levels under 12; mWomen with menstrual cycles between 25 and 34 days; Both Ovary present Exclusion criteria: Ovarian responsiveness and very low ovaries; Age over 40 years; High and equal to FSH; AMH less than or equal to 1; Antral follicles under 7; Any glandular disease
Intervention groups
150 infertile patients are randomly divided into three groups. 50 people at the time of the final trigger of DIF, 1. 50 at DIF, 2. 50 at DIF. Prior to initiation of the study, baseline AMH and FSH levels were measured in all patients.
Main outcome variables
Fertility rate; Implantation rate; Abortion rate; giving birth; The possibility of ovarian hyperstimulation; Number and quality of oocytes; Oocyte number M2; Number and quality of embryos

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190409043212N2
Registration date: 2020-01-20, 1398/10/30
Registration timing: retrospective

Last update: 2020-01-20, 1398/10/30
Update count: 0
Registration date
2020-01-20, 1398/10/30
Registrant information
Name
Sara Davoodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 2365
Email address
sdavoodi9798@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-12-27, 1394/10/06
Expected recruitment end date
2016-12-26, 1395/10/06
Actual recruitment start date
2015-12-27, 1394/10/06
Actual recruitment end date
2016-03-25, 1395/01/06
Trial completion date
2016-03-25, 1395/01/06
Scientific title
Comparison of IVF outcome in antagonist cycles by using different dosages of GnRH agonist (0.1, 0.2, and 0.3 diphereline) in triggering of final oocyte maturation in infertile women referring to Mother & Child hospital in 2014&2015
Public title
Evaluating the Effects of GnRH agonist (0.1, 0.2, and 0.3 diphereline) in triggering of final oocyte maturation in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with aged between 20-40 years Women with FSH levels under 12 Women with menstrual cycles between 25 and 34 days Women with both Ovary
Exclusion criteria:
Ovarian hyper stimulation and very low responses Follicular stimulating hormone >= 12 Anti-mullerian hormone=<1 Antral follicular count < 7 Any glandular disease
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 150
Actual sample size reached: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software Minitab; Sequence Building: Using randomized 4 in 4 blocks; Hiding method: Use similar bottles
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
Medical Science Researching، Shiraz Univercity of Medical Science
Street address
Shiraz University of Medical Sciences، Zand Street، Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Approval date
2015-12-06, 1394/09/15
Ethics committee reference number
IR.SUMS.MED.REC.1394.66

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Number and quality of oocytes
Timepoint
After Pickup
Method of measurement
sonography

2

Description
Number and quality of embryos
Timepoint
After fertilization
Method of measurement
Sonography

3

Description
Implantation
Timepoint
After trnasfer
Method of measurement
BHCG test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 50 people 0.1 dipherelin at the time of the final trigger, subcutaneous injection 34 hours before ovum pick up.
Category
Treatment - Drugs

2

Description
Intervention group: 50 people 0.2 dipherelin at the time of final trigger, subcutaneous injection 34 hours before ovum pick up.
Category
Treatment - Drugs

3

Description
Intervention group: 50 people 0.3 dipherellin at the time of final trigger, subcutaneous injection 34 hours before ovum pick up.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mother & Child of Ghadir Hospital
Full name of responsible person
Sara Davoodi
Street address
Shiraz, Before Quran gate, Golshan town, Mothrer and Child of Ghadir hospital
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3227 9701
Fax
+98 71 3227 9701
Email
sadavoodi9798@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Yoones 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 3235 7282
Fax
+98 71 3235 7282
Email
ghasemiy@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
Sara Davoodi
Position
Fellowship
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3233 2365
Email
sadavoodi9798@gmial.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Almataj Samsami
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3233 2365
Email
samsamia@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Infertility Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Sara Davoodi
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3233 2365
Email
Sadavoodi9798@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is 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
IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient
When the data will become available and for how long
IPD: 2019 Ethic form: 2019
To whom data/document is available
IPD: Researcher & Patient Ethic form: Patient
Under which criteria data/document could be used
IPD: Ethic form: Awareness of test results
From where data/document is obtainable
IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences
What processes are involved for a request to access data/document
IPD: Vice chancellery Ethic form: Vice chancellery
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