Protocol summary
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Study aim
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Implementing a mental health intervention program for oocyte donors
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Design
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Quasi-experimental study, 2 Groups, as concurrent on 72 Oocyte donors
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Settings and conduct
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The program is designed as a semi-experimental study on Oocyte donors eligible to enter the study, which will be conducted in the Isfahan and in the fertility infertility center. Before the donation process begins, the mental health of the oocyte donors is measured using the DASS-21 questionnaire. After implementing the program, the mental health of oocyte donors is measured again with the mentioned questionnaire.
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Participants/Inclusion and exclusion criteria
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Iranian Healthy oocyte donors
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Intervention groups
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First, in the control group and before the implementation of the mental health intervention program, the mental health of Oocyte donors are measured using the DASS-21 questionnaire. Then, The intervention program that designed based on interviews with Oocyte donors and service providers to them, is implemented in order to improving the structure of service delivery. After then, the mental health of Oocyte donors is measured again using the DASS-21 questionnaire.
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Main outcome variables
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Depression, Anxiety and stress
General information
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Reason for update
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edit the kind of study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200617047811N1
Registration date:
2020-07-25, 1399/05/04
Registration timing:
prospective
Last update:
2022-10-13, 1401/07/21
Update count:
1
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Registration date
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2020-07-25, 1399/05/04
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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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2020-09-21, 1399/06/31
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Expected recruitment end date
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2021-02-18, 1399/11/30
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Actual recruitment start date
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2020-09-21, 1399/06/31
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Actual recruitment end date
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2021-02-08, 1399/11/20
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Trial completion date
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2021-02-18, 1399/11/30
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Scientific title
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Implementing a Mental Health Intervention Program for Oocyte Donor Women
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Public title
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Mental Health Program in Oocyte Donor Women
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Iranian oocyte donors that a maximum of six months have passed from their entrance to the process of donation
No history of hospitalization or the use of medicine because of mental disorders
Absence of stress, anxiety and severe depression
No history of ovarian hyper-stimulation syndrome in previous donation
No legal problem related to donation
Exclusion criteria:
More than 6 months have passed from their last donation
Occurrence of medical problems following previous donations
Existence of psychological illness based on the diagnosis of a psychiatrist
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Age
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No age limit
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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:
72
Actual sample size reached:
72
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Randomization (investigator's opinion)
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N/A
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Randomization description
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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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Single
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Other design features
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Secondary Ids
1
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Registry name
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Thai Clinical Trials Registry
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Secondary trial Id
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TCTR20191209001
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Registration date
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2019-12-05, 1398/09/14
Ethics committees
1
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Ethics committee
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Approval date
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2019-11-19, 1398/08/28
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1398.492
Health conditions studied
1
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Description of health condition studied
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Mental Health
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ICD-10 code
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F34
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ICD-10 code description
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Persistent mood [affective] disorders
Primary outcomes
1
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Description
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Depression
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Timepoint
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Before the start of the oocyte donation and after oocyte pick-up
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Method of measurement
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Depression, anxiety and stress DASS 21 Scale
2
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Description
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Anxiety
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Timepoint
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Before the start of the oocyte donation and after oocyte pick-up
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Method of measurement
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Depression, anxiety and stress DASS 21 Scale
3
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Description
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Stress
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Timepoint
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Before the start of the oocyte donation and after oocyte pick-up
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Method of measurement
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Depression, anxiety and stress DASS 21 Scale
Intervention groups
1
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Description
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Intervention group: Intervention is a program that will be done with the aim of improving the structures. It should be noted that the exact content of the program will be determined after interviewing key participants. The program will implement until the end of the day of ovulation as each person enters the oocyte donation process.
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Category
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Prevention
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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Esfahan 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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Data on the main consequences of depression, anxiety and stress are generally shared.
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When the data will become available and for how long
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Start access 6 months after printing results
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To whom data/document is available
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Everyone has access.
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Under which criteria data/document could be used
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Available for systematic review and meta-analysis.
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From where data/document is obtainable
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For information, applicants can refer to the library of the Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences.
Also, the resulting articles can be sent by e-mail to adibme921@gmail.com, if needed.
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What processes are involved for a request to access data/document
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After publishing the articles and publishing the obtained dissertation, the applicant can access the desired information by referring to the library of Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences or by requesting email to adibme921@gmail.com.
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Comments
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