Protocol summary
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Study aim
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The aim of this randomized clinical trial is comparison of the effect of FSH (follice - stimulating hormone) administration plus HCG(human chorionic gonadotropin) at the time of oocyte trigger and HCG alone on IVF cycles outcomes as well as ovarian hyperstimulatiopn syndrom.
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Design
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A total of 109 women who met inclusion criteria, who were convinced about the research design and signed a written consent form were divided into two groups during a not-blinded, phase 2, parallel groups, without control group randomized clinical trial.
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Settings and conduct
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Regarding the importance of oocyte triggering in IVF cycles, 109 women at Yazd Research and Clinical Center who were candidate for IVF, were randomly divided into two groups for oocyte triggering (one group using FSH plus hCG or hCG alone in another group).
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Women undergoing IVF and GnRH antagonist protocol.
Non inclusion criteria: severe male factor infertility, cycle cancellation due to changing to intrauterine insemination and freeze-all policy, a cycle containing preimplantation genetic diagnosis (PGD) and estradiol level of more than 2500 pg/mL, donor or surrogate cycle.
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Intervention groups
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Intervention group 1: Oocyte triggering using FSH plus hCG; Intervention group 2: Oocyte triggering using hCG alone
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Main outcome variables
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Clinical pregnancy; oocyte recovery rate; oocyte maturity rate; fertilization proportion rate; fertilization rate; implantation rate; chemical pregnancy
General information
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Reason for update
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Updating the clinical trial according to the last changes in case number and results
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017082724512N5
Registration date:
2017-09-22, 1396/06/31
Registration timing:
registered_while_recruiting
Last update:
2021-03-23, 1400/01/03
Update count:
2
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Registration date
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2017-09-22, 1396/06/31
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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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Yazd Reproductive Sciences Institute ,Shahid Sadoughi University of Medical Sciences.
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Expected recruitment start date
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2017-08-01, 1396/05/10
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Expected recruitment end date
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2018-01-20, 1396/10/30
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Actual recruitment start date
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2017-08-01, 1396/05/10
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Actual recruitment end date
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2017-10-07, 1396/07/15
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Trial completion date
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2017-11-30, 1396/09/09
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Scientific title
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Comparison between FSH administration with HCG and HCG alone at the time of trigger in IVF cycles outcomes
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Public title
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The effect of FSH administration with HCG at the time of trigger on IVF cycles outcomes
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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 who candidate for IVF cycles underwent GnRH antagonist protocol
Fresh embryo transfer cycles
Exclusion criteria:
Women with history of endocrine disorders
serum estradiol>2500pg/ml in day of trigger
Intrauterine abnormality (uterine polyp; uterine myoma)
Severe male factor
Cycle cancellation or changing to intrauterine insemination
A cycle containing preimplantation genetic diagnosis (PGD)
Women who did not undergo embryo transfer due to the freeze-all policy
Donor or surrogate cycle
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Age
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From 20 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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2-3
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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:
152
Actual sample size reached:
109
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A number of 109 women who met inclusion criteria were explained about the procedure and after signing the written consent form, divided randomly into two groups using random numbers 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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Ethics committees
1
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Ethics committee
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Approval date
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2017-05-21, 1396/02/31
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Ethics committee reference number
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IR.SSU.RSI.REC.1396.7
Health conditions studied
1
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Description of health condition studied
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Female infertility
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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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chemical pregnancy
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Timepoint
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14 days after transfer
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Method of measurement
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BHCG test
2
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Description
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clinical pregnancy
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Timepoint
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2 weeks after positive BHCG
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Method of measurement
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Transvaginal sonography
Secondary outcomes
1
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Description
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Fertilization proportion
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Timepoint
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Post oocyte retrival
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Method of measurement
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The number of fertilized oocytes divided by the total number of oocytes
2
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Description
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oocyte recovery rate
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Timepoint
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After oocyte retrieval
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Method of measurement
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The number of retrieved oocytes divided by the number of follicles >10 mm in size counted on the day of trigger
3
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Description
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oocyte maturity rate
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Timepoint
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After oocyte retrieval
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Method of measurement
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the number of metaphase II (MII) oocytes divided by the number of oocytes retrieved
4
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Description
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Fertilization rate
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Timepoint
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After formation of 2PNs
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Method of measurement
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the number of 2PNs divided by the total number of MII oocytes
5
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Description
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Implantation rate
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Timepoint
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After detection of gestational sac in ultrasonography
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Method of measurement
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the number of intrauterine gestational sacs observed by transvaginal ultrasonography divided by the total number of transferred embryos
Intervention groups
1
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Description
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Patients in the first intervention group received injection of 450 IU FSH with 5000 IU hCG once on the day of oocyte triggering.
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Category
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Treatment - Drugs
2
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Description
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Patients in the second intervention group received injection of 5000 IU hCG once on the day of oocyte 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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Deputy of Research and Technology, Shahid Sadoughi University
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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 can be shared after making people unidentifiable
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When the data will become available and for how long
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Once data publication
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To whom data/document is available
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people working in academic institutions
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Under which criteria data/document could be used
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Journal who publishes the results
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From where data/document is obtainable
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Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran.
+98353 8247085
Dr. Saeedeh Dashti
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What processes are involved for a request to access data/document
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Two months after the submission of application
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Comments
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