Protocol summary
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Study aim
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Evaluation and comparison of two Trigger methods, dubble trigger (HCG + GNRH agonist) and Trigger with HCG on oocyte maturation in patients with poor ovarian response.
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Design
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In this randomized clinical trial with parallel group design, 90 infertile women with poor ovarian response were divided into two intervention 1 and 2 groups. Participates don't aware of the study grouping.
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Settings and conduct
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This study is done at Yazd infertility clinic.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Based on the Bologna criteria, poor responder women are included in the study who have two of the following three criteria:
Age more than 40 years or other risk factors for poor ovarian response; Less than three oocytes in the previous IVF cycle; Abnormal ovarian reserve test;
Two episodes of poor ovarian response with maximal stimulation in previous cycles without other criteria.
Exclusion criteria:
Severe male factor; Untreated endocrine disorders; Severe uterine anomaly;
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Intervention groups
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All patients under antagonist protocol receive 250-300 unit recombinant FSH from the second day of menstrual cycle and when dominant follicle size be13-14 mm , the antagonist (cetrotide or olegalotran ampoule) is started at a dose of 250 μg daily and continues until trigger day.
Intervention group 1: In this group Trigger done with 0.2 mg Deca peptil ampoule and 1000unit HCG ampoule 34-40 hours before oocyte retriveal.
Intervention group 2: In this group triggers were performed by standard trigger method with 1000 HCG units approximately 36 hours before oocyte retriveal.
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Main outcome variables
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Follicles number; Number of recovered oocytes; Number of embryos; Pregnancy rate.
General information
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Reason for update
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type of blinding correction
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190409043207N2
Registration date:
2019-10-22, 1398/07/30
Registration timing:
registered_while_recruiting
Last update:
2021-08-11, 1400/05/20
Update count:
3
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Registration date
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2019-10-22, 1398/07/30
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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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2019-09-06, 1398/06/15
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Expected recruitment end date
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2020-02-09, 1398/11/20
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Actual recruitment start date
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2019-09-06, 1398/06/15
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Actual recruitment end date
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2020-02-09, 1398/11/20
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Trial completion date
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2020-08-22, 1399/06/01
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Scientific title
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Comparison of two methods of double- trigger (GNRHa+HCG) and HCG-trigger on the final oocyte maturation in poor responder patients.
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Public title
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Comparison of the oocyte quality in patients with poor ovarian response undergone two triggering methods.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age more than 40 years or other risk factors for poor ovarian response.
Less than three oocytes in the previous IVF cycle
Abnormal ovarian reserve test
Two histories of poor ovarian response following receiving maximal stimulation
Exclusion criteria:
Severe male factor
Untreated endocrine disorders
Severe uterine anomaly
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Age
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From 18 years old to 50 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:
122
Actual sample size reached:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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For randomization selection of the patients, through the site www. randomization.ir, we create a list of random numbers for assigning patients to treatment groups (A&B). Then, the number of each patient, which is according to the entrance number to the clinic, is written on the envelope, and the type of treatment that was randomly selected through the mentioned site is put in the envelope. Also, thick envelopes are used in the aim to not be identifiable, the type of treatment for each patient, in the envelope, by the people who make the random assignment of the patient. In this way, each patient, who refer for giving treatment, comes with an envelope containing the type of assigned treatment.
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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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2019-07-28, 1398/05/06
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Ethics committee reference number
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IR.SSU.RSI.REC.1398.011
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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N98.9
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ICD-10 code description
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Complication associated with artificial fertilization, unspecified
Primary outcomes
1
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Description
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Clinical pregnancy rate
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Timepoint
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Four weeks after positive beta hCG
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Method of measurement
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Fetal heart activity by trans-vaginal ultrasonography
Secondary outcomes
1
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Description
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Biochemical pregnancy rate
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Timepoint
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14 days after embryo transfer
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Method of measurement
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Positive B-HCG
2
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Description
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Implantation rate
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Timepoint
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4 weeks after embryo transfer
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Method of measurement
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It is defined as the numbers of gestational sacs that detected throughout sonography per number of embryos transferred (100 embryo)
3
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Description
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Abortion rate
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Timepoint
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Before 20th weeks of gestation.
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Method of measurement
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Observation and counting
4
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Description
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COC counting
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Timepoint
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The day of oocyte puncture
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Method of measurement
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Counting
5
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Description
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MII oocyte number
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Timepoint
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The day of puncture
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Method of measurement
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Counting
6
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Description
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2PN number
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Timepoint
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1 day after fertilization
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Method of measurement
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Counting
7
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Description
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Estradiol level
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Timepoint
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In the day of hCG injection
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Method of measurement
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Biochemical measurements in the blood
8
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Description
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Embryo grading
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Timepoint
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3 days after puncture
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Method of measurement
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Observation and grading according to the embryo references
Intervention groups
1
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Description
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Intervention group: Intervention group: Trigger with 0.2 mg deca peptil ampoule and 10000 HCG ampoule 40 and 34 hours before oocyte retrieval.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Trigger by standard method with 10000units HCG 36 hours before oocyte retrieval.
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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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All data obtained from this study will be released after being unidentified studies participants
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When the data will become available and for how long
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Get started 6 months after publishing the study results
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To whom data/document is available
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The findings of this study will be accessible for all individuals
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Under which criteria data/document could be used
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To improve pregnancy outcomes of the infertility centers
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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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Receiving the author's confirmation and obtaining approval from the director of the Yazd Infertility Clinic
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Comments
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