Protocol summary
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Study aim
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Influence of GNRH agonist in luteal phase support for assisted reproductive techniques
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Design
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a clinical trial with two parallel arms non randomized patient group
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Settings and conduct
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20-39 years old infertile normal responder patients candidate for IVF,divide to two non randomized parallel group,in case group we inject 0.1mg triptorlin in days 0-3-6 plus 400 mg intravaginal cyclogest twice daily.in control group we just prescribe 400 mg intra vaginal cyclogest twice daily for luteal phase support.
2 weeks after tansfering serum BHCG will check and 2 weeks after positive BHCG,vaginal sonography for checking gestatioal sac and fetal heart rate will be done.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria :Age between 20-39 years-fresh embryo transfer cycles-
Exclusion criteria : low ovarian response ovarian hyper stimulation-oocyte donation-sever endothriosis
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Intervention groups
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Infertile women with normal ovarian response that subcutaneus inject of triptorelin 0/1 mg 0-3-6 days after fresh transfer
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Main outcome variables
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Chemical pregnancy-clinical pregnancy
General information
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Reason for update
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Updating the trial according to the last changes in methods
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110509006420N20
Registration date:
2020-03-11, 1398/12/21
Registration timing:
registered_while_recruiting
Last update:
2021-06-07, 1400/03/17
Update count:
3
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Registration date
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2020-03-11, 1398/12/21
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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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2020-01-01, 1398/10/11
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Expected recruitment end date
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2020-03-30, 1399/01/11
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Actual recruitment start date
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2020-01-01, 1398/10/11
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Actual recruitment end date
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2020-03-30, 1399/01/11
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Trial completion date
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2020-05-15, 1399/02/26
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Scientific title
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Effects of GnRH agonist for luteal phase support in assisted reproductive cycles
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Public title
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Effects of GnRH agonist for luteal phase support
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
age 20-39 years
fresh embryo transfer cycles
HCG -triggered cycles
Exclusion criteria:
Absence of good quality embryo
Ovarian hyper stimulation (more than 18 mature follicles with size more than 14 mm during ovarian stimulation) or estradiol level in trigger days more than 4000 pmol/l
Severe male factor
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Age
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From 20 years old to 39 years old
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Gender
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Female
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Phase
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2
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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:
200
Actual sample size reached:
168
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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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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2019-12-29, 1398/10/08
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Ethics committee reference number
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IR.SSU.RSI.REC.1398.043
Health conditions studied
1
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Description of health condition studied
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female infertility
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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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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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serum BHCG
2
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Description
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clinical pregnancy
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Timepoint
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6 weeks after embryo transfer
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Method of measurement
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sonography
Intervention groups
1
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Description
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taking 0/1 mg triptorelin in 0-3-6 days after fresh emeryo transfer plus 400mg vaginal cyclogest twice daily for luteal phase support.
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Category
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Treatment - Drugs
2
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Description
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Control group: taking 400mg vaginal cyclogest twice daily for luteal phase support.
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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available