Protocol summary
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Study aim
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Effect of delayed start GnRH protocol in ovarian poor responders
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Design
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Interventional clinical trial with control and parallel groups, non-blind, randomized, phase 2 was performed on 72 patients. Randomization was performed using random number table.
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Settings and conduct
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The objective of this study is evaluating the effect of delayed start protocol in ovarian poor responders. Study population: Infertile women with poor ovarian response candidate for IVF. Study groups: Intervention and control groups. Sample size: 72 poor responder women. This is a randomized not blinded trial, in one center, in phase 2 study. Setting and conduct: Ovarian poor responders after obtaining informed consent randomized into intervention and control groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patient with Bologna criteria for ovarian poor responders
Exclusion criteria: History of endocrine disorders, severe endometriosis, azoospermia.
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Intervention groups
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In the intervention group with delayed protocol: First, like the control group, estradiol valerate 4 mg daily for 10 days starts from the 20th day of the previous menstrual cycle, then 7 days of daily administration of gonadotropin-releasing hormone antagonist (0.25 mg cetrorelix acetate) begins. The ovaries are then stimulated with 375 u gonadotropins.
In the control group ovarian stimulation was performed using standard GnRH protocol with 375u gonadotropin.
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Main outcome variables
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Number of mature oocytes (MII) and total number of oocytes
General information
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Reason for update
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Updating the trial according to the last changes in Actual sample size reached and secondary outcomes
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015100424335N1
Registration date:
2016-01-18, 1394/10/28
Registration timing:
retrospective
Last update:
2021-08-10, 1400/05/19
Update count:
3
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Registration date
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2016-01-18, 1394/10/28
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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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2015-03-01, 1393/12/10
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Expected recruitment end date
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2015-09-30, 1394/07/08
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Actual recruitment start date
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2015-03-01, 1393/12/10
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Actual recruitment end date
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2015-09-30, 1394/07/08
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Trial completion date
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2016-03-30, 1395/01/11
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Scientific title
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Comparison of the effect of delayed start GnRH antagonist protocol and usual antagonist protocol on oocyte count and pregnancy rate in ART cycle in poor ovarian responders
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Public title
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Effect of delayed start protocol in outcome of ART cycle in poor ovarian responders
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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 according to Bologna criteria. At least two of the following three features must be present:
Advanced maternal age (≥40 years) or any other risk factor for poor ovarian response;
A previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol);
An abnormal ovarian reserve test (i.e. AFC <5–7 follicles or AMH <1.1 ng/ml).
Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder.
Exclusion criteria:
History of endocrine and metabolic disorders
endometriosis
azoospermia
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Age
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From 18 years old to 45 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:
72
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this trial,72 infertile women with poor ovarian response were informed about the research design and signed a written consent form. All women were randomly divided into two groups. Randomization was simple, individual, not blinded, using a random number table.
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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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Randomized with enveloped pocket method
Ethics committees
1
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Ethics committee
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Approval date
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2015-06-07, 1394/03/17
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Ethics committee reference number
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148
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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Mature oocytes count
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Timepoint
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Oocyte retrieval day
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Method of measurement
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Counting number of mature oocytes with microscope
2
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Description
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Total oocytes count
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Timepoint
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Oocyte retrieval day
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Method of measurement
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Counting number of total oocytes with microscope
Secondary outcomes
1
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Description
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Number of embryo
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Timepoint
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On the 2nd day after ICSI
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Method of measurement
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Observation with microscope
2
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Description
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Chemical pregnancy
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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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Serum βhCG
3
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Description
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Clinical pregnancy
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Timepoint
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3 weeks after positive serum βhCG
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Method of measurement
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Vaginal ultrasonography
4
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Description
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oocyte maturity rate (MII number /total oocytes number)
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Timepoint
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oocyte retrieval day
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Method of measurement
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with microscope
5
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Description
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oocyte yield (total oocytes number /antral follicle count [AFC])
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Timepoint
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oocyte retrieval day for oocyte count and before the start of the ivf cycle for antral follicles
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Method of measurement
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With microscope for oocytes and vaginal ultrasound for antral follicles
6
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Description
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mature oocyte yield (MII number/AFC)
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Timepoint
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oocyte retrieval day for mature oocyte count and before the start of the ivf cycle for antral follicles
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Method of measurement
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With microscope for mature oocytes and vaginal ultrasound for antral follicles
7
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Description
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total dosage of gonadotropin
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Timepoint
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End of IVF cycle
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Method of measurement
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Count the dose of gonadotropin received
8
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Description
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ovarian stimulation days
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Timepoint
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End of IVF cycle
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Method of measurement
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Counting the days of ovarian stimulation
9
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Description
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fertilization rate (two-pronuclear [2PN]/ MII)
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Timepoint
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16 hr after Intra-cytoplasmic sperm injection
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Method of measurement
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With microscope
10
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Description
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Implantation rate (the number of gestational sacs divided/the number of transferred embryos)
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Timepoint
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3 week after positive serum βhCG
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Method of measurement
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Vaginal ultrasonography
11
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Description
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Ongoing pregnancy rate
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Timepoint
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after 12 week gestation
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Method of measurement
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ultrasound
12
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Description
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miscarriage rate
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Timepoint
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miscarriages before 20 weeks gestation
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Method of measurement
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ultrasound
Intervention groups
1
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Description
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In intervention group 0/25 mg/vial cetrorelix( GNRH antagonist), one vial daily, subcutaneous, for 7 days, before starting COH. Then start ovarian stimulation with 375 units of gonadotropin
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Category
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Treatment - Drugs
2
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Description
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in control group patients treated with antagonist protocol with 375 units of gonadotropin, without GNRH antagonist pretreatment.
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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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Vice Chancellor for research of Shahid Sadoughi 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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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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The final result of the study will be published and there is no need to share individual participants' data
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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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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
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Title and more details about the data/document
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The final result of the study will be published and there is no need to share individual participants' data
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When the data will become available and for how long
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The final result of the study will be published and there is no need to share individual participants' data
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To whom data/document is available
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The final result of the study will be published and there is no need to share individual participants' data
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Under which criteria data/document could be used
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The final result of the study will be published and there is no need to share individual participants' data
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From where data/document is obtainable
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The final result of the study will be published and there is no need to share individual participants' data
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What processes are involved for a request to access data/document
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The final result of the study will be published and there is no need to share individual participants' data
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Comments
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