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Protocol summary
Quasi-experimental study as a single design, before and after on 72 Oocyte donors
Quasi-experimental study, 2 Groups, as concurrent on 72 Oocyte donors
Quasi-experimental study, 2 Groups, as a single design, before and afterconcurrent on 72 Oocyte donors
مطالعه نیمه تجربی به صورت دیزاین تنها، به صورت قبل و بعد بر روی 72 زن اهداکننده تخمک
مطالعه نیمه تجربی، دو گروهی، به صورت همزمان بر روی 72 زن اهداکننده تخمک
مطالعه نیمه تجربی به صورت دیزاین تنها، دو گروهی، به صورت قبل و بعدهمزمان بر روی 72 زن اهداکننده تخمک
General information
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72
72
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2020-09-21, 1399/06/31
2020-09-21 00:00:00
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2021-02-08, 1399/11/20
2021-02-08 00:00:00
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2021-02-18, 1399/11/30
2021-02-18 00:00:00
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edit the kind of study
edit the kind of study
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ویرایش نوع مطالعه
ویرایش نوع مطالعه
Recruitment centers
#1
Name of recruitment center - English: Isfahan Fertility Infertility Center of
Name of recruitment center - Persian: مرکز باروری ناباروری اصفهان
Full name of responsible person - English: Seyyed Mehdi Ahmadi
Full name of responsible person - Persian: سید مهدی احمدی
Street address - English: Isfahan, Bozorgmehr Square, Salman Farsi St
Street address - Persian: اصفهان، میدان بزرگمهر، خیابان سلمان فارسی
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8158858151
Phone: +98 31 3267 0030
Fax:
Email: info@isf-ific.com
Web page address:
Name of recruitment center - English: Isfahan Fertility Infertility Center
Name of recruitment center - Persian: مرکز باروری ناباروری اصفهان
Full name of responsible person - English: Seyyed Mehdi Ahmadi
Full name of responsible person - Persian: سید مهدی احمدی
Street address - English: No. 23, Corner of Behesht St., Salman Farsi St., (Moshtagh II St.), Bozorgmehr Square, Isfahan, Iran.
Street address - Persian: اصفهان، میدان بزرگمهر، خیابان سلمان فارسی (مشتاق دوم)، نبش خیابان بهشت، شماره 23
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8158858151
Phone: +98 31 3267 0030
Fax:
Email: info@isf-ific.com
Web page address:
Name of recruitment center - English: Isfahan Fertility Infertility Center of Name of recruitment center - Persian: مرکز باروری ناباروری اصفهان Full name of responsible person - English: Seyyed Mehdi Ahmadi Full name of responsible person - Persian: سید مهدی احمدی Street address - English: IsfahanNo. 23, Corner of Behesht St., Salman Farsi St., (Moshtagh II St.), Bozorgmehr Square, Salman Farsi StIsfahan, Iran. Street address - Persian: اصفهان، میدان بزرگمهر، خیابان سلمان فارسی (مشتاق دوم)، نبش خیابان بهشت، شماره 23 City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8158858151 Phone: +98 31 3267 0030 Fax: Email: info@isf-ific.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Vice-Chancellor in Research Affairs
Full name of responsible person - Persian: معاونت تحقیقات و فناوری
Street address - English: Hezar Jerib street , Isfahan University of Medical Sciences
Street address - Persian: خیابان هزار جریب، دانشگاه علوم پزشکی و خدمات بهداشتی درمانی اصفهان
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3792 3071
Fax:
Email: international@mui.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Behrooz Ataie
Full name of responsible person - Persian: دکتر بهروز عطایی
Street address - English: Vice-Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St., Isfahan, Iran.
Street address - Persian: اصفهان، خیابان هزار جریب، دانشگاه علوم پزشکی و خدمات بهداشتی درمانی اصفهان، ساختمان شماره ۴- معاونت تحقیقات و فناوری دانشگاه
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3792 3071
Fax:
Email: international@mui.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Vice-Chancellor in Research AffairsDr Behrooz Ataie Full name of responsible person - Persian: معاونت تحقیقات و فناوریدکتر بهروز عطایی Street address - English: Hezar Jerib street Vice-Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St., Isfahan, Iran. Street address - Persian: اصفهان، خیابان هزار جریب، دانشگاه علوم پزشکی و خدمات بهداشتی درمانی اصفهان، ساختمان شماره ۴- معاونت تحقیقات و فناوری دانشگاه City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8174673461 Phone: +98 31 3792 3071 Fax: Email: international@mui.ac.ir Web page address:
Protocol summary
Study aim
Implementing a mental health intervention program for oocyte donors
Design
Quasi-experimental study, 2 Groups, as concurrent on 72 Oocyte donors
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Iranian Healthy oocyte donors
Intervention groups
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.
Main outcome variables
Depression, Anxiety and stress
General information
Reason for update
edit the kind of study
Acronym
IRCT registration information
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
Registration date
2020-07-25, 1399/05/04
Registrant information
Name
Elham Adibmoghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 4869
Email address
e.adib@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-21, 1399/06/31
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
2020-09-21, 1399/06/31
Actual recruitment end date
2021-02-08, 1399/11/20
Trial completion date
2021-02-18, 1399/11/30
Scientific title
Implementing a Mental Health Intervention Program for Oocyte Donor Women
Public title
Mental Health Program in Oocyte Donor Women
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Actual sample size reached:
72
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
1
Registry name
Thai Clinical Trials Registry
Secondary trial Id
TCTR20191209001
Registration date
2019-12-05, 1398/09/14
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Vice-Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-11-19, 1398/08/28
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.492
Health conditions studied
1
Description of health condition studied
Mental Health
ICD-10 code
F34
ICD-10 code description
Persistent mood [affective] disorders
Primary outcomes
1
Description
Depression
Timepoint
Before the start of the oocyte donation and after oocyte pick-up
Method of measurement
Depression, anxiety and stress DASS 21 Scale
2
Description
Anxiety
Timepoint
Before the start of the oocyte donation and after oocyte pick-up
Method of measurement
Depression, anxiety and stress DASS 21 Scale
3
Description
Stress
Timepoint
Before the start of the oocyte donation and after oocyte pick-up
Method of measurement
Depression, anxiety and stress DASS 21 Scale
Secondary outcomes
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Intervention groups
1
Description
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.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Fertility Infertility Center
Full name of responsible person
Seyyed Mehdi Ahmadi
Street address
No. 23, Corner of Behesht St., Salman Farsi St., (Moshtagh II St.), Bozorgmehr Square, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8158858151
Phone
+98 31 3267 0030
Email
info@isf-ific.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Behrooz Ataie
Street address
Vice-Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
international@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data on the main consequences of depression, anxiety and stress are generally shared.
When the data will become available and for how long
Start access 6 months after printing results
To whom data/document is available
Everyone has access.
Under which criteria data/document could be used
Available for systematic review and meta-analysis.
From where data/document is obtainable
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.
What processes are involved for a request to access data/document
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.