Protocol summary
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Study aim
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evaluating the effect of intrauterine infusion of G-CSF on pregnancy rate. study groups are infertile patients
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Design
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A clinical trial with the control group, with parallel groups, not blinded, phase 3 per 100 patients. A random number table was used for randomization.
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Settings and conduct
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This study is performed in Yazd Infertility Research Center. 100 IVF candidate patients are divided into 2 groups using a random table. One group receives the usual antagonist stimulation protocol. In the control group, in addition to the antagonist protocol, 300 micrograms of granulocyte colony-stimulating factor are infused into the endometrial cavity by intrauterine insemination catheter on the day of egg puncture.
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Participants/Inclusion and exclusion criteria
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inclusion : infertile women aged 18-40 years old with normal endometrial thickness who were candidates for IVF
exclusion : Women with a history of repeated implantation failure , endocrine disorders, severe endometriosis, congenital or acquired uterine anomaly, renal disease, sickle cell disease, or malignancy history, upper respiratory tract infection, pneumonia, chronic neutropenia
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Intervention groups
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Intervention: injection of 300 micrograms G-CSF in the uterine cavity with IUI catheter in oocyte retrieval day
control: oocyte retrieval will be done 36 hours after HCG triggering and embryos will be transferred 2 days latter.
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Main outcome variables
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chemical pregnancy, clinical pregnancy, Implantation rate, ongoing pregnancy , the miscarriage rate
General information
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Reason for update
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Updating exclusion criteria and outcomes according to the last methodological changes
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201508236420N13
Registration date:
2015-11-07, 1394/08/16
Registration timing:
retrospective
Last update:
2021-08-23, 1400/06/01
Update count:
1
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Registration date
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2015-11-07, 1394/08/16
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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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Vice chancellor for research, Shahid Sadoughi University of Medical Science
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Expected recruitment start date
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2015-03-21, 1394/01/01
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Expected recruitment end date
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2015-09-23, 1394/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of granulocyte colony stimulating factor (G-CSF) on IVF outcome and pregnancy rates.
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Public title
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Effect of granulocyte colony stimulating factor in ART treatment
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
infertile women
candidate for IVF
normal endometrial thickness
age18-40 years old
Exclusion criteria:
repeated implantation failure
endocrine disorders
severe endometriosis
congenital or acquired uterine anomaly
renal disease
sickle cell disease
malignancy history
upper respiratory tract infection
pneumonia
chronic neutropenia
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Age
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From 18 years old 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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No information
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Sample size
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Target sample size:
100
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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, infertile women who were scheduled for ART and met the inclusion criteria, informed about the research design and signed a written consent form for random assignment either to case or control groups. All women were randomly divided into two groups using simple, individual through random number table. All women were consecutively assigned into two groups based on randomized list.
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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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2015-02-08, 1393/11/19
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Ethics committee reference number
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444
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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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
Secondary outcomes
1
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Description
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ongoing pregnancy
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Timepoint
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10 weeks after embryo transfer
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Method of measurement
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sonography
2
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Description
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abortion
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Timepoint
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18 weeks after embryo transfer
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Method of measurement
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sonography
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 BHCG
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Method of measurement
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sonography
4
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Description
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implantation
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Timepoint
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3 weeks after positive BHCG
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Method of measurement
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assessed by the number of gestational sacs per number of transferred embryos
Intervention groups
1
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Description
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In intervention group in oocyte retrieval day, 300 microgram G-CSF ampoul infused in endometrial cavity with IUI catheter immediately after retrieval.
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Category
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Treatment - Drugs
2
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Description
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in control group (50 patients) G-CSF not infused in endometrial cavity.
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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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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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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 study
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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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