Protocol summary
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Study aim
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(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.
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Design
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Randomized, controlled clinical trial, in parallel with a control group
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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sexual function
General information
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Reason for update
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Provide project's results.
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Acronym
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IRCT registration information
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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
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Registration date
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2019-04-07, 1398/01/18
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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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2019-05-05, 1398/02/15
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Expected recruitment end date
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2019-07-06, 1398/04/15
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Actual recruitment start date
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2019-08-27, 1398/06/05
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Actual recruitment end date
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2019-12-28, 1398/10/07
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Trial completion date
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2019-12-28, 1398/10/07
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Scientific title
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The effect of sexual counseling based on BETTER model on sexual function of infertile women.
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Public title
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The effect of sexual counseling on sexual function of infertile women.
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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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:
80
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Permuted block randomization
Individual randomization
Online randomization
Allocation concealment: Using opaque envelopes
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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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2019-03-09, 1397/12/18
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Ethics committee reference number
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IR.ABZUMS.REC.1397.216
Health conditions studied
1
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Description of health condition studied
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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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Sexual function
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Timepoint
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Before intervention, two months after intervention
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Method of measurement
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Female Sexual Function Index
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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Control group: 40 infertile women entered the study according to entry criteria. This tutorial will be given to this group.
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Category
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Behavior
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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Karaj 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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Total potential data can be shared after unidentifiable people
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When the data will become available and for how long
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Data will be in access 6 months after publishing the results.
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To whom data/document is available
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Only for researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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scientific studies
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From where data/document is obtainable
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Using Email Address:marmarmzf@gmail.com
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What processes are involved for a request to access data/document
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Up to a week after sending the email address
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Comments
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