An interventional study of AI-Enabled Fertility Counseling and Standard Educational Materials or PDF laboratory reports in Fertility Awareness, Ovarian Reserve and Family Planning, sponsored by City University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to female participants aged 25 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by City University of Hong Kong · Not applicable, Interventional, and Screening
This study evaluates the impact of preventive ovarian reserve screening and artificial intelligence (AI)-enabled counseling on fertility awareness and reproductive anxiety among women in Hong Kong. Hong Kong faces low birth rates, and reproductive anxiety regarding the biological clock remains a key barrier to family planning. Participants aged 25 to 38 years will be allocated to receive either anti-Müllerian hormone (AMH) blood testing combined with counseling or standard health education materials. The study compares an interactive AI conversational agent ("Shelby") with traditional written reports to evaluate whether AI communication improves comprehension of medical results, reduces anxiety, and enhances fertility intentions. Findings aim to inform future public health screening policies.
This joint study by the City University of Hong Kong (CityU) and The Chinese University of Hong Kong (CUHK) investigates the impact of preventive ovarian reserve screening and artificial intelligence (AI)-enabled health counseling on reproductive anxiety and family planning intentions among women in Hong Kong.
Hong Kong currently faces record-low fertility rates. While the government has implemented various financial subsidies and tax incentives, these measures fail to address the underlying psychological barriers and medical uncertainties surrounding biological clocks. To address this gap, the study employs a 2 x 2 quasi-experimental design using propensity score matching and RCT applied to evaluate 660 nulliparous women aged 25 to 38 years:
Key outcome measures evaluated at baseline and at a 2- to 4-week follow-up include medical comprehension accuracy, psychological distress assessed via the State-Trait Anxiety Inventory (STAI-6), patient enablement (PEI), willingness to pay, and long-term fertility intentions. Strict ethical safeguards and distress protocols are integrated to automatically escalate any acute psychological distress to professional counselors. The findings will provide empirical evidence to support policy recommendations for territory-wide subsidized fertility screening in public healthcare.
City University of Hong Kong is the lead sponsor of 25 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo Anti-Müllerian Hormone (AMH) blood testing. Personalized biomarker results and tailored fertility counseling are delivered via the interactive AI conversational agent ("Shelby"). Outcomes are assessed post-intervention.
Behavioral: AI-Enabled Fertility Counseling
Participants undergo Anti-Müllerian Hormone (AMH) blood testing. Biomarker results are delivered via a conventional static laboratory report displaying reference ranges without AI interaction.
Behavioral: Standard Educational Materials or PDF laboratory reports
Participants do not undergo AMH blood testing. If requested, participants are provided digital access to the AI conversational agent ("Shelby") for general fertility and reproductive health education without personalized biomarker data.
Behavioral: AI-Enabled Fertility Counseling
Participants do not undergo AMH blood testing and serve as the standard control. If requested, participants are provided access to standard informational websites/materials regarding general reproductive health.
Behavioral: Standard Educational Materials or PDF laboratory reports
An interactive AI conversational agent ('Shelby', shecare.ai) providing personalized, culturally tailored fertility education and AMH test interpretation with built-in safety protocols.
Provision of conventional static health education materials via standard medical brochures and/or standard PDF laboratory reports with reference ranges without interactive conversational AI features.
Change in Fertility Intentions and Reproductive Planning
Assessed by comparing participants' responses to a standardized fertility intentions questionnaire completed at two time points (pre- and post-intervention). The questionnaire evaluates shifts in childbearing timeline, desired family size, interest in fertility preservation following AMH testing and educational delivery.
Time frame: 2 to 4 weeks post-intervention
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Laboratory Anti-Müllerian Hormone (AMH) assay values. Raw conversational logs and direct identifying personal data will not be shared to protect participant privacy."
Supporting information: Study protocol, Statistical analysis plan
Time frame: 6 months and ending 36 months following article publication.
Access criteria: Data will be shared with approved researchers following a signed data access agreement and IRB approval.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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City University of Hong Kong