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

Determining the effect of a designed educational-consulting program based on artificial intelligence technology on fertility attitudes and motivation in childless married women

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.

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.

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.

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.

Attitudes towards fertility and childbearing, childbearing motivation

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

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.

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.

The documents and data files will be available starting 6 months after the main publication and will remain accessible for at least 5 years.

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.

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.

Requests should be directed via email to: Dr. Fatemeh Bakouei Babol University of Medical Sciences Email: bakouei2004@yahoo.com

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.

None at this time.