Protocol summary
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Study aim
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The comparison of oocyte maturity rate between the two triggering methods using GnRH agonist protocol
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Design
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In a randomized , parallel groups, phase 2 clinical trial with control group, 112 patients with PCOS undergoing GnRH antagonist protocol were randomly divided into two groups of double and single dose triggering method using random number table.
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Settings and conduct
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This study was performed on 112 PCOS patients referred to Yazd Research and Clinical Center for Infertility. The patients received GnRH antagonist group for ovulation induction. On the oocyte triggering day patients were randomly divided into two groups. In the case group oocyte triggering was performed with a single dose of decapeptyl 0.2 mg and after 12 hours the second dose of decapeptyl 0.1 mg was injected.
The control group was triggered by only one dose of decapeptyl 0.2 mg.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: PCOS women aged 20-38 years with body Mass Index > 18 and < 30 and serum estradiol level more than 3000 pg/ml on triggering day and ovarian stimulation with GnRH antagonist protocol
Exclusion criteria: Sever endometriosis, Sever male factor infertility, Uterine anomaly and Metabolic disease
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Intervention groups
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The cases were triggered by decapeptyl 0.2 milligram at first and secondly a dose of decapeptyl 0.1 milligram after 12 hours . The control group was triggered by one dose of decapeptyl 0.2 milligram.
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Main outcome variables
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Oocyte maturity rate
General information
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Reason for update
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Updating the trial regarding actual sample size, actual recruitment start and end dates
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181211041930N1
Registration date:
2018-12-22, 1397/10/01
Registration timing:
registered_while_recruiting
Last update:
2021-04-14, 1400/01/25
Update count:
1
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Registration date
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2018-12-22, 1397/10/01
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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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2018-12-10, 1397/09/19
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Expected recruitment end date
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2019-02-19, 1397/11/30
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Actual recruitment start date
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2018-12-15, 1397/09/24
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Actual recruitment end date
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2019-05-30, 1398/03/09
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Trial completion date
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2019-07-30, 1398/05/08
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Scientific title
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A comparison between the effect of two kinds of triggering with GnRh agonist in PCOS patients treated by antagonist protocol for ART on oocyte and embryo quality
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Public title
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The effect of two kinds of triggering with GnRh agonist in antagonist protocol
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
PCOS women based on Rotterdam criteria who were candidate for ART
Serum estradiol level more than 3000 pg/ml on triggering day
Ovarian stimulation with GnRH antagonist protocol
Age between 20-38 years
Body Mass Index > 18 and < 30
Exclusion criteria:
Sever endometriosis
Sever male factor infertility
Uterine anomaly
Metabolic disease
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Age
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From 20 years old to 38 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:
120
Actual sample size reached:
112
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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 we choose 112 patients who met the inclusion criteria ,and 1 to 112 numbers were assigned to each participants consecutively. The patients were divided into two 56-participant groups by using random allocation soft ware and random codes generation. At the time of patients' visit, they were allocated into two groups based on their random generated numbers.
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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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2018-12-02, 1397/09/11
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Ethics committee reference number
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IR.SSU.RSI.1397.022
Health conditions studied
1
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Description of health condition studied
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Triggering with different doses of GnRh a in PCO patients
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ICD-10 code
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N97.9
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ICD-10 code description
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Female infertility, unspecified
Primary outcomes
1
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Description
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The number of mature oocytes (MII)
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Timepoint
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After oocyte retrieval
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Method of measurement
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Counting mature oocyte under microscopy
2
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Description
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Number of 2PNs
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Timepoint
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16 hours After fertilization
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Method of measurement
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Counting 2PNs under microscopy
3
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Description
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OHSS developing
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Timepoint
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Days 4 and 7 post oocyte pick-up
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Method of measurement
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Measuring ovarian size, presence of free fluid in Douglas.
Secondary outcomes
1
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Description
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Embryos quality and embryo count
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Timepoint
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48 hours after fertilization
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Method of measurement
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Assessment under microscopy by embryologist.
Intervention groups
1
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Description
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Intervention group: The intervention group were triggered by injection of decapeptyl 0.2 mg, following by the second dose of decapeptyl 0.1 mg after 12 hours.
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Category
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Treatment - Drugs
2
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Description
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Control group: The control group was triggered by decapeptyl 0.2 mg.
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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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Yes - There is a plan to make this available
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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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The study protocol, the statistical analysis map, the clinical study report will be available after the publishing of the article .
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When the data will become available and for how long
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After publishing the article
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To whom data/document is available
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Researchers working in academic institutions
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Under which criteria data/document could be used
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Use in the retrospective studies
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From where data/document is obtainable
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Yazd Research and Clinical Center for Infertility
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What processes are involved for a request to access data/document
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Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, the request is referred to the research experts and then get the data.
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Comments
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