Protocol summary
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Study aim
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Determining the effectiveness of infertility instructor program on the perceived stress of women and the outcome of the treatment of women under treatment for assisted reproductive techniques
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Design
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A clinical trial with a control group with parallel, randomized groups
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Settings and conduct
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This study will be conducted in the infertile women who are candidates of and ICSI while filling in the Newton Stress questionnairre before the intervention the Stress management strategies will be educated to them in the pancher day In this study, the research environment of Imam Khomeini Hospital infertility treatment center And Maryam Sari
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Women under the age of 45, primary infertility, women under IVF and ICSI treatment, reading and writing;
Non-compliance criteria: Use no Cigarette, hookah and drink alcohol, having systemic diseases such as diabetes, under consulting of psychologist or psychiatrist during the study or at least one month before the start of the study, Have major psychiatric disorder during the study period (diagnose by primary visit by psychiatrist) and consumption of psychiatric drugs, Have adopted child, Do intend to use the embryo and oocyte donation or a rented uterus
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Intervention groups
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Intervention group: Visiting the patient before and after of visit in six stages of the first session of the day 2 or 3 of cycle before the baseline sonography, the second session of the day 2 or 3 of the subsequent cycles, the third session 10 days after receiving the drug, the 4 session pancake day, session 5 the day of transfer day and session 6 two weeks after transfer
Control group: Routine center care
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Main outcome variables
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perceived Stress related to infertility
General information
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Reason for update
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Multi center sampling was updated to single center.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180811040762N1
Registration date:
2018-11-11, 1397/08/20
Registration timing:
registered_while_recruiting
Last update:
2019-12-15, 1398/09/24
Update count:
1
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Registration date
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2018-11-11, 1397/08/20
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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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2018-07-23, 1397/05/01
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Expected recruitment end date
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2019-03-21, 1398/01/01
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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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The effect of infertility coach program on the level of percieved stress and treatment outcome of women under the treatment of assisted reproductive techniques
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Public title
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Effect of infertility coach program on the level of percieved stress and treatment outcome of women under the treatment of assisted reproductive techniques
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women less than 45 years
Primary infertility
Women treated with IVF and ICSI (maximum 3 times)
Iranian nationality
Having reading and writing ability
Exclusion criteria:
Use no Cigarette, hookah and drink alcohol
having systemic diseases such as diabetes, hypertension, hyperlipidemia and thyroid gland disease based on the treatment history, information of records and reports of the research unit
under consulting of psychologist or psychiatrist during the study or at least one month before the start of the study
Have major psychiatric disorder during the study period (diagnose by primary visit by psychiatrist) and consumption no psychiatric drugs
Have adopted child
Do intend to use the embryo and oocyte donation or a rented uterus
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Age
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From 20 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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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:
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 the current randomized intervention,two groups with 30 patients are allocated in intervention and control groups Devided between groups will be done through random method ,in other word 60 envelopes are considered and intervention and control groups are defined with a and b letter. This envelopes will be assigned to any included indiviuals of study randomely and ultimately, patients will be taken in to the intervention and control groups. This calculation was performed through the G-power software
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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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2018-07-11, 1397/04/20
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Ethics committee reference number
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IR.MAZUMS.REC.1397.149
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
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ICD-10 code description
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Female infertility
Primary outcomes
1
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Description
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Perceived Stress related to infertility
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Timepoint
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Before the intervention, puncture day, day of embryo transfer, day of pregnancy test
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Method of measurement
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Newton Infertility Stress Questionnaire
2
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Description
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The outcome of assisted reproduction treatment
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Timepoint
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Two weeks after embryo transfer
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Method of measurement
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By using Beta-HCG measurement by blood tests
Secondary outcomes
1
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Description
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The number of oocytes obtained
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Timepoint
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Immediately after intervention
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Method of measurement
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View by embryologists
2
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Description
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The fertilization rate
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Timepoint
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5 after the intervention
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Method of measurement
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View by embryologists
3
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Description
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Pregnancy outcome
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Timepoint
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Three weeks after the intervention
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Method of measurement
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Beta-HCG measurement by blood tests
Intervention groups
1
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Description
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اntervention group: 1. description of genital anatomy, reproductive hormones,Also how the effect of stress and negative emotions on hormonal and physiological changes in the reproductive system Explanation of the stages of treatment with IVF.The Second session on days 19 to 20 of Cycle: Before the visit,the responding to possible questions of patient,Speak regarding the improvement of the negative emotions control Attendance at a visit,Answer to the possible patient questions of the after completing the visit,On day2of the next cycle (approximately 10 days after the second session): counseling on improving communication skills,Setting predeterminead questions using a patient's possible worries,Attendance at a visit,After visiting about the with the counseling of medications,The fourth session on 6-8th cycle (about one week after the third meeting): Stress reduction and effective coping strategies methods.Attendance at a visit,Fifth session on removal oocyte day and around day 14: A brief explanation about oocyte oocyte removal operation ,Answer to the possible patient questions of the after completing the visit,Transfering day: A brief description about the transfer operation,Answer to the possible patient questions of the after completing the visit,
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Category
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Treatment - Other
2
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Description
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Control group: Routine center care
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Category
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N/A
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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Sari 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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No more information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available