Protocol summary
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Study aim
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Determining the effect of a designed educational-consulting program based on artificial intelligence technology on fertility attitudes and motivation in childless married women
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Design
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Eighty participants will be randomly allocated to each of the two groups: an intervention group will receive parenting counseling via an AI chat bot, and the control group will receive routine parenting counseling.
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Settings and conduct
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This study will be conducted among women who attend comprehensive health centers in Mahmudabad city to receive health services. Participants will be screened according to the study’s inclusion and exclusion criteria. Eligible women will be provided with information about the study objectives and a brief description of the procedures. Those who agree to participate will complete and sign a written informed consent form.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria include married women aged 18-40 years, Iranian nationality, first marriage, childless (women who have been married for at least 6 months and are not currently pregnant), low or average desire to have children, access to the Internet and a smartphone, and having at least 9 years of education and exclusion criteria include women with maternal or fetal medical contraindications to pregnancy, known chronic physical and mental illnesses, speech and hearing disorders, drug addiction and unwillingness to participate in the study.
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Intervention groups
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The intervention group will receive the designated childbearing counseling content for service providers through an AI chat bot intervention delivered in four weekly sessions at times scheduled by the study participants. The control group will receive the same content routinely by healthcare providers.
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Main outcome variables
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Attitudes towards fertility and childbearing, childbearing motivation
General information
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Reason for update
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I submitted the manuscript protocol to a journal. The reviewers suggested that I add the inclusion criterion "ability to interact with AI/digital platforms". Since I haven't started sampling yet, if possible, this criterion should be added.
In addition, the editor asked me to complete the data sharing section and update the expected recruitment start date, so I added the relevant content in the relevant section. Thanks
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20221109056451N7
Registration date:
2025-11-14, 1404/08/23
Registration timing:
prospective
Last update:
2026-06-13, 1405/03/23
Update count:
1
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Registration date
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2025-11-14, 1404/08/23
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Registrant information
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Recruitment status
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Not yet recruiting
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Funding source
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Expected recruitment start date
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2026-08-23, 1405/06/01
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Expected recruitment end date
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2027-03-19, 1405/12/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of a designed educational-consulting program based on artificial intelligence technology on fertility attitudes and motivation in childless married women: A randomized controlled trial
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Public title
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An educational-consulting program based on artificial intelligence technology on the fertility attitude and motivation of childless married 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:
Married women aged 18-40 years
Iranian nationality
First marriage
Childless (women who have been married for at least 6 months and are not currently pregnant)
Low or average desire to have children based on a fertility preference question score below 8
Access to the Internet and a smartphone
Having at least 9 years of education
ability to interact with artificial intelligence/digital platforms
Exclusion criteria:
Women with maternal or fetal medical contraindications to pregnancy
Known chronic physical and mental illnesses
Speech and hearing disorders (preventing communication with the researcher)
Drug addiction according to the individual's statements
Unwillingness to participate in the study
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Age
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From 18 years old to 40 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
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Eligible women will be randomly assigned to either the control or intervention group using a 1:1 block randomization method with blocks of four. To ensure concealment of allocation, only the first supervisor will have access to the randomization list, which will be generated using Random Allocation Software. The researcher will communicate participant eligibility to the supervisor, who will then provide the group assignment based on the block file prepared by the statistics consultant.
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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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2025-11-09, 1404/08/18
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Ethics committee reference number
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IR.MUBABOL.HRI.REC.1404.172
Health conditions studied
1
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Description of health condition studied
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Attitudes and motivation towards childbearing
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ICD-10 code
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ICD-10 code description
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Primary outcomes
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Description
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Attitude to fertility
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Timepoint
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Before and one month after the intervention
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Method of measurement
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Questionnaire of attitudes towards fertility and child bearing
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Description
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Fertility motivation
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Timepoint
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Before and one month after the intervention
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Method of measurement
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Miller's Fertility Motivation Questionnaire
Secondary outcomes
1
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Description
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Fertility knowledge
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Timepoint
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Before and one month after the intervention
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Method of measurement
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Cardiff Fertility Knowledge Scale
Intervention groups
1
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Description
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Intervention group: Participants randomized to the intervention arm will receive a structured educational-counseling program based on artificial intelligence technology through an AI-powered chat bot platform, delivered across four weekly sessions scheduled at each participant's convenience. The intervention protocol begins with a standardized set of researcher-developed questions derived from the National Guidelines for Childbearing Counseling for Healthcare Providers, which are embedded within the chat bot interface. Following this initial structured interaction, participants will have the opportunity to pose personalized questions to refine their understanding and receive tailored advice.
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Category
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Behavior
2
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Description
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Control group: Participants allocated to the control arm will receive conventional childbearing counseling as specified in the National Guidelines, administered through standard in-person consultations with trained healthcare providers.
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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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Babol 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be 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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Deidentified Individual Participant Data (IPD) – This includes all deidentified participant data related to primary and secondary outcome measures, will collect through questionnaires and clinical records. Study Protocol – Full finalized protocol submitted to the ethics committee. Statistical Analysis Plan (SAP) – Final version describing the statistical methods used for primary and secondary outcomes. Informed Consent Form – Blank version of the informed consent form used for participant enrollment. Analytic Code – R/Stata/SPSS scripts used for statistical analysis. Data Dictionary – A detailed guide to the variables, definitions, formats, and codes used in the dataset.
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When the data will become available and for how long
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The documents and data files will be available starting 6 months after the main publication and will remain accessible for at least 5 years.
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To whom data/document is available
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Data and documents will be made available to researchers affiliated with academic or nonprofit institutions, with a clear and valid research purpose. Requests from commercial entities may be considered case-by-case.
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Under which criteria data/document could be used
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Data/documents can be used only for secondary analyses related to reproductive health, fertility, or public health. Proposals will be reviewed by the principal investigator and research ethics coordinator. Data will be shared via secure data transfer.
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From where data/document is obtainable
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Requests should be directed via email to: Dr. Fatemeh Bakouei Babol University of Medical Sciences Email: bakouei2004@yahoo.com
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What processes are involved for a request to access data/document
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Interested researchers should submit: A short proposal (max 1 page) Ethics approval (if applicable) Signed data use agreement Requests will be reviewed within 2–4 weeks. Access will be granted after approval and agreement signature.
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Comments
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None at this time.