Protocol summary
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Study aim
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Study the effect of androgen administration on IVF outcome in poor responders undergoing ovarian stimulation with microdose protocol
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Design
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Two arm parallel grou randomised trial
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Settings and conduct
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Infertile woman refer to reproductive sciences institute
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Participants/Inclusion and exclusion criteria
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Poor responders
Sever endometriosis, Sever male factor, Uncontrol endocrine disease
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Intervention groups
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Study the effect of adding androgen to ovarian stimulation with microdose protocol in study group and comparison with only microdose protocol in control group on IVF outcome in poor responders
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Main outcome variables
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Clinical pregnancy, Chemical pregnancy, Fetus number,Oocyte number, Dominant follicle
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180818040828N1
Registration date:
2018-10-18, 1397/07/26
Registration timing:
registered_while_recruiting
Last update:
2021-04-20, 1400/01/31
Update count:
1
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Registration date
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2018-10-18, 1397/07/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-09-23, 1397/07/01
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Expected recruitment end date
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2018-11-22, 1397/09/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of androgen administration on IVF outcome in poor responders undergoing ovarian stimulation with microdose protocol
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Public title
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The effect of androgen administration on IVF outcome in poor responders
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patient with poor responder ovaries
Age <45 years
Age >18 years
Exclusion criteria:
Sever Endomtriosis
Sever Male Factor
Uncontrol Endocrine Disease
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At first the 60 qualified patients select and in order to refer from number 1 to 60 consider for them.Then with Random Allocation Software and random codes divide in two groups with 30 patients.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-05-20, 1397/02/30
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Ethics committee reference number
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IR.SSU.RSI.REC.1397.001
Health conditions studied
1
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Description of health condition studied
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Patient with poor responder ovareis
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ICD-10 code
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N97
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ICD-10 code description
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Female infertility
Primary outcomes
1
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Description
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Clinical pregnancy
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Timepoint
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5 Week after embryo transfer
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Method of measurement
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Vaginal Sonography to see fetus in gestational sac
Secondary outcomes
1
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Description
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Chemical pregnancy
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Timepoint
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2 weeks after embryo transfer
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Method of measurement
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Check BHCG
2
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Description
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Fetus number
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Timepoint
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2-3 day after follicle aspiration
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Method of measurement
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Fetus in labratory
3
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Description
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Oocyte number
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Timepoint
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In follicular aspiration day
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Method of measurement
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To see oocytes in labratory
4
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Description
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The number of dominant follicle
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Timepoint
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In ovulation stimulation cycle
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Method of measurement
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Vaginal sonography
5
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Description
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Estradiol level in blood
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Timepoint
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To see 2-3number of >=17 mm follicle
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Method of measurement
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Check in labratoty
6
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Description
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Gonadotropin dosage
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Timepoint
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At the end of ovarian stimulation
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Method of measurement
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International Units
Intervention groups
1
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Description
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Intervention group: Since the 3rd day of menses will begin GnRH agonist buserelin acetate (Cinafact,cinagen,Iran) at a dose of 50 μg subcutaneously twice daily and menotropin(BSV,Germany ) 325 IU daily intramuscular.Follicular size with sonography and serum FSH, LH, P, and E2 level will be measured on cyle day 7 and then every 2-3 days one time. When serum FSH levels exceeded 20 IU/L on cycle day 7 or any time thereafter and follicular growth will considered to be slow or asynchronous (when one or two leading follicles were ≥4 mm larger than the rest of the cohort), gonadotropins will discontinue for 2-5 days. 40.5 mg of daily transdermal testosterone ( Androgel 1.62% , Abbvie) will begin from the day gonadotropin injections will interrupt until the day of the ovulation trigger. When at least two dominant follicles will reach to size of ≥17 mm, 10,000 IU hCG (Pregnyl, Netherlands) was administered subcutaneously for ovulation trigger. Thirty-six hours later, the oocytes were retrieved by means of ultrasound-guided transvaginal needle aspiration. Following egg retrieval, intracytoplasmic sperm injection/IVF will be done. The embryos will transferre at the cleavage stage 2-3 days later.
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Category
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Treatment - Drugs
2
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Description
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Control group:Since the 2d day of menses GnRH agonist buserelin acetate (Cinafact,cinagen,Iran) at a dose of 50 μg subcutaneously twice daily and since the 4th day menotropin(BSV,Germany ) 325 IU daily intramuscular will begin.Follicular size with sonography will be measured on cyle day 9 and then every 2-3 days one time. In this group gonadotropin will not interrupt and will continue until trigger day. When at least two dominant follicles will reach to size of ≥17 mm,serum FSH,LH,P and E2 levels will be measured and10,000 IU hCG (Pregnyl, Netherlands) will administere subcutaneously for ovulation trigger. Thirty-six hours later, the oocytes were retrieved by means of ultrasound-guided transvaginal needle aspiration. Following egg retrieval, intracytoplasmic sperm injection/IVF will be done. The embryos will transferre at the cleavage stage 2-3 days later.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Due to the privacy of patients
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Study protocol,statistical analysis map,clinical study report after article edition will be available
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When the data will become available and for how long
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After article edition
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To whom data/document is available
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Researchers that work in university
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Under which criteria data/document could be used
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In retrospective studies
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From where data/document is obtainable
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Yazd reproductive sciences institute
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What processes are involved for a request to access data/document
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Demand from Vice president of research,propound in Research council of infertility center and after acception refer to research expert and receive the data
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Comments
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