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General information
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2019-08-27, 1398/06/05
2019-08-27 00:00:00
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2019-12-28, 1398/10/07
2019-12-28 00:00:00
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2019-12-28, 1398/10/07
2019-12-28 00:00:00
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Provide project's results.
Provide project's results.
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اتمام طرح و اعلام نتایج
اتمام طرح و اعلام نتایج
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Protocol summary
Study aim
(GENERAL OBJECTIVES):Determining the effect of sexual counseling based on BETTER model on sexual function of infertile women.(SPECIFIC OBJECTIVES):1- Determination and comparison of the mean of sexual function score in infertile women before and two months after the intervention in the intervention group.
2. Determination and comparison of mean sexual function score in infertile women before and two months after intervention in control group.
3. Determination and comparison of mean sexual performance score in infertile women before and two months after intervention in two intervention and control groups.
4. Determining the relationship between marital satisfaction and sexual function.
Design
Randomized, controlled clinical trial, in parallel with a control group
Settings and conduct
This study was performed on 80 infertile women who referred to the Infertility Center of Karaj and infertility center of Taleghani Hospital in Tehran. Samples are randomly distributed from each center (40 people per center) based on entrance criteria and randomly assigned to each intervention and control group.
Participants/Inclusion and exclusion criteria
ge between 20 - 45 years
Married and living with a spouse
At least 6 months have passed since infertility diagnosis
Primary infertility
Do not have a adopted child
Iranian nationality
Spoken in farsi
having at least middle School degree
Having at least one sexual problem based on a short screening form
Intervention groups
40 infertile women entered the study according to entry criteria. For each person, two sexual counseling sessions will be held on a weekly basis.Each counseling session will take about 60-90 minutes. Data were collected before and two months after the intervention with demographic forms, the female sexual function index and Enrich marital satisfaction questionnaire.
Main outcome variables
sexual function
General information
Reason for update
Provide project's results.
Acronym
IRCT registration information
IRCT registration number:IRCT20161230031662N8
Registration date:2019-04-07, 1398/01/18
Registration timing:prospective
Last update:2021-05-21, 1400/02/31
Update count:1
Registration date
2019-04-07, 1398/01/18
Registrant information
Name
Razieh Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
raziehlotfi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2019-07-06, 1398/04/15
Actual recruitment start date
2019-08-27, 1398/06/05
Actual recruitment end date
2019-12-28, 1398/10/07
Trial completion date
2019-12-28, 1398/10/07
Scientific title
The effect of sexual counseling based on BETTER model on sexual function of infertile women.
Public title
The effect of sexual counseling on sexual function of infertile women.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 - 45 years
Married and living with a spouse
At least 6 months have passed since infertility diagnosis
Primary infertility
Do not have a adopted child
Iranian nationality
Spoken in farsi
having at least middle School degree
Having at least one sexual problem based on a short screening form
Exclusion criteria:
menopause
pregnancy
medical conditions such as; diabetes, cardio-vascular diseases, hypertension...
Using drugs effective on sexual function, known mental disorders
Alcohol and drug abusing
Husband's sexual dysfunction
Participating in similar educational classes in the past 6 months
Loss a close relative in the past 3 months
Before intervention, two months after intervention
Method of measurement
Female Sexual Function Index
Secondary outcomes
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Intervention groups
1
Description
Intervention group: 40 infertile women entered the study according to entry criteria. For each person, two sexual counseling sessions will be held on a weekly basis.Each counseling session will take about 60-90 minutes. Data were collected before and two months after the intervention with demographic forms, the female sexual function index and Enrich marital satisfaction questionnaire.
Category
Behavior
2
Description
Control group: 40 infertile women entered the study according to entry criteria. This tutorial will be given to this group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouyesh infertility treatment center
Full name of responsible person
Maryam mohammadzadeh F
Street address
north Taleghani
City
Karaj
Province
Alborz
Postal code
3155784390
Phone
+98 26 3250 6247
Email
info@rouyeshfertility.com
2
Recruitment center
Name of recruitment center
Taleghani infertility treatment center
Full name of responsible person
Maryam mohammadzadeh F
Street address
Yaman street-Velenjak
City
tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 9982
Email
taleghanihospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Mohammad Noorisepehr
Street address
عظیمیه، طالقانی شمالی
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3464 4255
Email
dr.noorisepehr@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Alborz University of Medical Sciences
Full name of responsible person
maryam mohammadzadeh F
Position
BsC in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Square of Prophethood, Kara
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7685
Email
marmarmzf@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Razieh Lotfi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
1st Street Golestan, Eshteraki Boulevard, Baghestan, Kara
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 912 765 5855
Email
lotfi_razieh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
maryam mohammadzadeh F
Position
BCs in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Square of Nabovat, Karaj
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7685
Email
marmarmzf@yahoo.com
Sharing plan
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
Total potential data can be shared after unidentifiable people
When the data will become available and for how long
Data will be in access 6 months after publishing the results.
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
scientific studies
From where data/document is obtainable
Using Email Address:marmarmzf@gmail.com
What processes are involved for a request to access data/document