The effect of infertility coach program on the level of percieved stress and treatment outcome of women under the treatment of assisted reproductive techniques
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
Design
A clinical trial with a control group with parallel, randomized groups
Settings and conduct
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
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
perceived Stress related to infertility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180811040762N1
Registration date:2018-11-11, 1397/08/20
Registration timing:registered_while_recruiting
Last update:2018-11-11, 1397/08/20
Update count:1
Registration date
2018-11-11, 1397/08/20
Registrant information
Name
Roghayeh Soleimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3379 5555
Email address
fsoleimani1400@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of infertility coach program on the level of percieved stress and treatment outcome of women under the treatment of assisted reproductive techniques
Public title
Effect of infertility coach program on the level of percieved stress and treatment outcome of women under the treatment of assisted reproductive techniques
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In the current randomized intervention,two groups with 30 patients are classified in intervention and control groups Devided between groups will be done through lottery 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
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical science
Street address
Ethics committee of Mazandaran University of Medical science
City
sari
Province
Mazandaran
Postal code
4843163181
Approval date
2018-07-11, 1397/04/20
Ethics committee reference number
IR.MAZUMS.REC.1397.149
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Perceived Stress related to infertility
Timepoint
Before the intervention, puncture day, day of embryo transfer, day of pregnancy test
Method of measurement
Newton Infertility Stress Questionnaire
2
Description
The outcome of assisted reproduction treatment
Timepoint
Two weeks after embryo transfer
Method of measurement
By using Beta-HCG measurement by blood tests
Secondary outcomes
1
Description
The number of oocytes obtained
Timepoint
Immediately after intervention
Method of measurement
View by embryologists
2
Description
The fertilization rate
Timepoint
5 after the intervention
Method of measurement
View by embryologists
3
Description
Pregnancy outcome
Timepoint
Three weeks after the intervention
Method of measurement
Beta-HCG measurement by blood tests
Intervention groups
1
Description
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,
Category
Treatment - Other
2
Description
Control group: Routine center care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Maryam Infertility clinics
Full name of responsible person
Dr. Zeinab HamzehGardesi
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal street
City
sari
Province
Mazandaran
Postal code
48431-63181
Phone
+98 11 3334 3333
Fax
+98 11 3336 7342
Email
z.hamzehgardeshi@mazums.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Infertility Center of Imam Khomeini Hospital
Full name of responsible person
Dr. Zeinab HamzehGardesi
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal street Mazandaran Iran, Islamic Republic Of
City
sari
Province
Mazandaran
Postal code
48431-63181
Phone
+98 11 3336 7342
Fax
+98 11 3336 7342
Email
z.hamzehgardeshi@mazums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Gholam Ali Gedazandeh
Street address
Moalem Street, Vice chancellor for research Sari Mazandaran , Islamic Republic of Iran
City
sari
Province
Mazandaran
Postal code
48431-63181
Phone
+98 11 3336 7342
Email
z.hamzehgardeshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Zeinab HamzehGardesi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal Street, Amir Mazandarani Street Sari Mazandaran Iran, Islamic Republic Of
City
sari
Province
Mazandaran
Postal code
4843163181
Phone
+98 48 4316 3181
Fax
+98 11 3337 8915
Email
z.hamzehgardeshi@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Zeinab HamzehGardeshi
Position
Associate professo
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal Street, Amir Mazandarani Street Sari Mazandaran , Iran
City
sari
Province
Mazandaran
Postal code
48431-63181
Phone
+98 11 3379 5550
Email
hamzehgardeshi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Zeinab HamzehGardeshi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal Street, Amir Mazandarani Street Sari Mazandaran
City
Sari
Province
Mazandaran
Postal code
48431-63181
Phone
011-33795555-01133115500
Email
z.hamzehgardeshi@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available