Protocol summary
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Study aim
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The aim of present study is to evaluate the effect of reduced dose of long-acting gonadotropin releasing hormone (GnRH) agonist versus short acting GnRH agonist on pregnancy outcome in patients undergoing intracytoplasmic sperm injection outcome.
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Design
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Phase III, with a parallel group, double blinded, randomized clinical trial with 400 participants in two groups of long (n=200) and short-acting gonadotropin releasing hormone (GnRH) agonist (n=200)
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Settings and conduct
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The aim of present study is to evaluate the effect of reduced dose of long-acting gonadotropin releasing hormone (GnRH) agonist versus short acting GnRH agonist on pregnancy outcome in patients undergoing intracytoplasmic sperm injection outcome at Mehr medical institute. Block randomization will be done with a 4:4 allocation ratio. The physicians and patients will be blinded to group assignment.
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Participants/Inclusion and exclusion criteria
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Normal responders to ovarian induction
Inclusion criteria:
Age ≤ 40 years, Basal FSH level <8, Less than one failed ICSI cycle, Non PCOS patients, No azoospermia, No moderate to severe endometriosis
Exclusion criteria:
No response to ovulation induction, Difficult embryo transfer, Bloody embryo transfer
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Intervention groups
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First group: long-acting gonadotropin releasing hormone (GnRH) agonist
Second group: short-acting gonadotropin releasing hormone (GnRH) agonist
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Main outcome variables
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Biochemical and clinical pregnancy rate will be considered as main endpoint.
General information
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Reason for update
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Completion of the project
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190609043845N1
Registration date:
2019-06-20, 1398/03/30
Registration timing:
prospective
Last update:
2023-06-20, 1402/03/30
Update count:
2
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Registration date
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2019-06-20, 1398/03/30
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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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2019-07-29, 1398/05/07
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Expected recruitment end date
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2020-01-27, 1398/11/07
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Actual recruitment start date
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2019-07-29, 1398/05/07
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Actual recruitment end date
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2020-02-17, 1398/11/28
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Trial completion date
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2020-07-28, 1399/05/07
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Scientific title
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Evaluation of the effect of reduced dose of long-acting gonadotropin releasing hormone (GnRH) agonist versus short acting GnRH agonist on pregnancy outcome in patients undergoing intracytoplasmic sperm injection outcome- clinical trial
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Public title
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Effect of reduced dose of long-acting GnRH agonist versus short acting GnRH agonist
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age ≤ 40 years
Basal FSH level <8
Less than one failed ICSI cycle
Non PCOS patients
No azoospermia
No moderate to severe endometriosis
Exclusion criteria:
No response to ovulation induction
Difficult embryo transfer
Bloody embryo transfer
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Age
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To 40 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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- Participant
- Care provider
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Sample size
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Target sample size:
400
Actual sample size reached:
400
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization will be done with a 4:4 allocation ratio.(https://www.sealedenvelope.com)
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Each patient will have an identification code (IC) which will be placed in sealed envelope by researcher. Also, medications will be placed in sealed containers with IC. The physicians and patients will be blinded to group assignment.
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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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2019-05-25, 1398/03/04
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Ethics committee reference number
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IR.GUMS.REC.1398.094
Health conditions studied
1
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Description of health condition studied
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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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Biochemical pregnancy rate
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Timepoint
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Two month after intervention
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Method of measurement
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Positive βhCG test (Lab kit)
2
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Description
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Clinical pregnancy rate
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Timepoint
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Two month after intervention
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Method of measurement
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Assessment of gestational sac and fetal heartbeat at 7 weeks of gestation (Vaginal ultrasonography)
Secondary outcomes
1
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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 induction cycle
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Method of measurement
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Total number of ampoule
2
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Description
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Duration of ovarian induction
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Timepoint
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At the end of ovarian induction cycle
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Method of measurement
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Number of days
Intervention groups
1
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Description
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Intervention group: long-acting gonadotropin releasing hormone (GnRH) agonist: Decapeptyl (1.25mg, Ferring) will be injected on 21st day of menstruation before the start of ovarian induction cycle.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: short-acting gonadotropin releasing hormone (GnRH) agonist: Cinnafact (Cinnagen) will be injected on 21st day of previous menstrual cycle at starting dose of 0.5 mg/daily and continued 0.25 mg/daily from 2st day of menstruation until the day of hCG administration.
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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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Guilan University of Medical Sciences
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Proportion provided by this source
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50
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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
2
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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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Mehr Fertility Research Center
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Proportion provided by this source
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50
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Public or private sector
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Private
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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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Industry
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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There is no further information
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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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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be 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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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Study Protocol and Clinical Study Report
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When the data will become available and for how long
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Starting after publication
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To whom data/document is available
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people working in academic institutions
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Under which criteria data/document could be used
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Starting after publication
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From where data/document is obtainable
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Roya Kabodmehri
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What processes are involved for a request to access data/document
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Email
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Comments
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