Protocol summary
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Study aim
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The aim of present study was to evaluate Dual trigger on oocyte maturation in POR patients and their ART out comes.
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Design
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Randomization was performed with a table of random numbers. The study was not blinded.
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Settings and conduct
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The study was not blinded.The study was conducted at the Yazd Infertility Research Center.
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Participants/Inclusion and exclusion criteria
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poor ovarian responders women (based on Bologna criteria) were included in the study. The exclusion criteria were endometrial polyps; presence of endocrine disorders (such as hyperprolactinemia, hypothyroidism), preimplantation genetic diagnosis cycles; and non fresh embryo transfer cycles.
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Intervention groups
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The gonadotropins were started on day 2 of the menstrual cycle. gonadotropins dose adjustments were done based on ovarian response .
The GnRH antagonist was administered when mean diameter of dominant follicles reached to 13–14 mm. When at least 3 follicles with ≥18 mm diameter were seen by vaginal ultrasonography. In the first group, final oocyte maturation was done by 6500 I.U.HCG alone. In the second group triggering was done with coadministration of 6500 I.U.HCG plus 0.2 mg triptorelin simultaneous (dual trigger).Oocytes retrieval was performed 36 h after triggering through transvaginal ultrasound guided.
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Main outcome variables
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Chemical pregnancies were confirmed 2 weeks after embryo transfer, by positive serum HCG measurement. Clinical pregnancy is defined by the presence of gestational sac in the uterus, 4 weeks after ET.
General information
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Reason for update
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Updating the trial according to the last changes in methods and adding results
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016111628756N4
Registration date:
2016-12-04, 1395/09/14
Registration timing:
retrospective
Last update:
2021-03-29, 1400/01/09
Update count:
1
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Registration date
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2016-12-04, 1395/09/14
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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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Shahid Sadoughi University of Medical Sciences
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Expected recruitment start date
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2016-05-01, 1395/02/12
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Expected recruitment end date
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2017-10-30, 1396/08/08
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Actual recruitment start date
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2016-07-01, 1395/04/11
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Actual recruitment end date
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2016-11-30, 1395/09/10
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Trial completion date
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2017-02-28, 1395/12/10
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Scientific title
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A comparison of Dual triggering versus HCG in poor responders in ART outcomes
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Public title
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A comparison of Dual triggering by administration of GnRH agonist plus HCG versus HCG in poor responders in ART outcomes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
poor ovarian responders women (based on Bologna criteria)
GnRH antagonist protocols
fresh embryo transfer
Exclusion criteria:
endometrial polyps
presence of endocrine disorders (such as hyperprolactinemia, hypothyroidism)
preimplantation genetic diagnosis cycles
non fresh embryo transfer cycles.
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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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:
82
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients are admitted to two groups of 41 patients on the basis of permutation block method. Therapeutic tasks within the blocks are determined in such a way that they are random, but the desired allocation ratio is achieved in each block.
20 blocks of 4 and a block of 2 are considered. Generate random codes using random block allocation method which will be generated with the help of Random allocation software version 1. The first person eligible to enter the study is given number one and so on until the last person eligible for number 82 is given. Using a table generated by random allocation software by number, people receive intervention A or B. In order to be blind, the random allocation of this list is given to another person outside the study, and by sending a text message before assigning the type of treatment, the eligible person is asked according to the number, and thus the people enter the study.
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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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2016-09-14, 1395/06/24
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Ethics committee reference number
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IR.SSU.RSI.REC.1395.18
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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N97.8
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ICD-10 code description
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Female infertility of other origin
Primary outcomes
1
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Description
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Number of metaphase II oocytes
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Timepoint
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After intervention
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Method of measurement
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number
Secondary outcomes
1
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Description
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number of fertilized oocytes (2PN)
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Timepoint
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after intervention
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Method of measurement
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number
2
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Description
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clinical pregnancy
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Timepoint
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28 days after transfer
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Method of measurement
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28 days after transfer
Intervention groups
1
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Description
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in intervention group co-administration of HCG and agonist used for triggering
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Category
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Treatment - Drugs
2
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Description
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in control group HCG used routinely for triggering
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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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shahid saoughi university of medical science
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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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All participant data sets are to be shared
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When the data will become available and for how long
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2 months after the result publication
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To whom data/document is available
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A journal in which the results are published
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Under which criteria data/document could be used
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Submission of an official application via the agent that is legally in charge
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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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Submission of an official application
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Comments
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Trial results
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Please tick if results have been published
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Yes
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Summary result posting date
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2021-03-29, 1400/01/09
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Table of baseline comparison
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Participant flow diagram
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Table of variable outcomes' results
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Table of adverse events
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First publication date
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2018-12-30, 1397/10/09
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Abstract of published paper
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Abstract
Background
The use of dual triggering in high and normal responders accompanied with better IVF cycle outcomes. Also, it has been suggested that dual triggering in poor responders can be accompanied by better results.
Objective
The aim of present study was to evaluate whether the Dual trigger, can improve oocyte maturation in poor responder patients based on Bologna criteria and their ART outcomes.
Materials and methods
All poor ovarian responder's patients underwent GnRH antagonist controlled ovarian hyperstimulation protocols in ART cycles. The participants' randomizations were done and patients divided into two groups. In the first group, final oocyte maturation was done by 6500 I.U.HCG alone. In the second group, triggering was done with coadministration of 6500 I.U.HCG plus 0.2 mg triptorelin simultaneous (dual trigger). Oocyte retrieval was performed 36 h after triggering through transvaginal ultrasound-guided. Routine IVF/ICSI was performed as appropriate.
Results
The number of retrieved oocytes, number of mature oocytes (MII), number of fertilized oocytes (2PN), number of embryo formation, number of transferred embryos and embryo quality have not significant differences between the two groups (p > 0.05). Also, fertilization and implantation rate, chemical and clinical pregnancy did not differ between groups.
Conclusion
Dual triggering for final oocyte maturation in poor ovarian responders did not improve the number of mature oocytes (MII) and other ART cycle results.