Fertility AwarenessNCT07894302
Improving Women's Fertility Awareness and Reducing Anxiety Through Ovarian Reserve Screening and AI Counseling
A study testing AI-Enabled Fertility Counseling and Standard Educational Materials or PDF laboratory reports in people with Fertility Awareness and Ovarian Reserve, run by City University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Awareness, Ovarian Reserve, Family Planning
- What is being tested?
- AI-Enabled Fertility Counseling and Standard Educational Materials or PDF laboratory reports
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Biologically female (assigned female at birth, with intact ovaries)
- Aged 25 to 38 years
- Fluent in written and spoken Chinese (Traditional or Simplified) or English
- Has access to an internet-enabled smartphone or computer
- Able to give electronic or written informed consent
Who cannot join
- Currently pregnant or breastfeeding
- Known active, severe psychiatric or cognitive disorder that prevents informed - consent or completing the questionnaire
- History of gynecological cancer
- Currently receiving gonadotoxic chemotherapy or pelvic radiotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
City University of Hong Kong
Hong Kong, Kowloon, 0000
Siu-Wai SIT, Master, +852 69026592, swsit6@city.edu.hk
Wai-Kit MING, PhD
About this study
Official title: Women Rise, Families Thrive: Advancing Women's Health and Fertility Awareness Through Ovarian Reserve Assessment in Hong Kong
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.
Read the detailed description
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:
- Intervention Group (n = 300): Participants receive an Anti-Müllerian Hormone (AMH) blood test to quantify ovarian reserve. Results are delivered either through an interactive, culturally tailored AI conversational agent named "Shelby" (Group 2A) or a traditional static PDF laboratory report (Group 2B).
- Control Group (n = 300): Participants receive standard reproductive health education without biomarker testing, comparing interactive AI engagement (Group 1A) against standard educational brochures (Group 1B).
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.
- Conditions
- Fertility Awareness, Ovarian Reserve, Family Planning
- Being tested
- AI-Enabled Fertility Counseling, Standard Educational Materials or PDF laboratory reports
- Keywords
- Anti-Mullerian Hormon, Ovarian Reserve Screening, Family Planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Enabled Fertility CounselingBehavioural
An interactive AI conversational agent ('Shelby', shecare.ai) providing personalized, culturally tailored fertility education and AMH test interpretation with built-in safety protocols.
Standard Educational Materials or PDF laboratory reportsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: AMH Testing with AI-Enabled Counseling | Experimental | 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. Receives: Behavioral: AI-Enabled Fertility Counseling |
| Intervention: AMH Testing with Static Lab Report | Experimental | Participants undergo Anti-Müllerian Hormone (AMH) blood testing. Biomarker results are delivered via a conventional static laboratory report displaying reference ranges without AI interaction. Receives: Behavioral: Standard Educational Materials or PDF laboratory reports |
| Control: Non-AMH with AI-Driven Fertility Education | Active comparator | 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. Receives: Behavioral: AI-Enabled Fertility Counseling |
| Control: Non-AMH with Standard Educational Website | Active comparator | 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. Receives: Behavioral: Standard Educational Materials or PDF laboratory reports |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 to 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start31 Mar 2026
- Primary completion30 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility AwarenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Primary Arm 1 (AMH Testing, n = 300): Cell 1 (n = 150): Receives AMH blood test results followed by an interactive explanation via the AI conversational agent "Shelby". Cell 2 (n = 150): Receives AMH blood test results delivered as a standard PDF laboratory report with reference ranges
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SIT Siu Wai, City University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894302
- Sponsor's protocol ID
- HU-STA-00002652
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Laboratory Anti-Müllerian Hormone (AMH) assay values. Raw conversational logs and direct identifying personal data will not be shared to protect participant privacy."
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women Rise, Families Thrive: Advancing Women's Health and Fertility Awareness Through Ovarian Reserve Assessment in Hong Kong
- ClinicalTrials.gov ID
- NCT07894302
- Acronym / sponsor ID
- HU-STA-00002652
- Conditions
- Fertility Awareness, Ovarian Reserve, Family Planning
- Keywords
- Anti-Mullerian Hormon, Ovarian Reserve Screening, Family Planning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- City University of Hong KongUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Intervention Group (n = 300): Participants receive an Anti-Müllerian Hormone (AMH) blood test to quantify ovarian reserve. Results are delivered either through an interactive, culturally tailored AI conversational agent named "Shelby" (Group 2A) or a traditional static PDF laboratory report (Group 2B).
- Control Group (n = 300): Participants receive standard reproductive health education without biomarker testing, comparing interactive AI engagement (Group 1A) against standard educational brochures (Group 1B).
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Primary Arm 1 (AMH Testing, n = 300): Cell 1 (n = 150): Receives AMH blood test results followed by an interactive explanation via the AI conversational agent "Shelby". Cell 2 (n = 150): Receives AMH blood test results delivered as a standard PDF laboratory report with reference ranges
| Arm | Type | Receives |
|---|---|---|
| Intervention: AMH Testing with AI-Enabled Counseling | Experimental | Behavioral: AI-Enabled Fertility CounselingParticipants 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. |
| Intervention: AMH Testing with Static Lab Report | Experimental | Behavioral: Standard Educational Materials or PDF laboratory reportsParticipants undergo Anti-Müllerian Hormone (AMH) blood testing. Biomarker results are delivered via a conventional static laboratory report displaying reference ranges without AI interaction. |
| Control: Non-AMH with AI-Driven Fertility Education | Active comparator | Behavioral: AI-Enabled Fertility CounselingParticipants 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. |
| Control: Non-AMH with Standard Educational Website | Active comparator | Behavioral: Standard Educational Materials or PDF laboratory reportsParticipants 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. |
Who may qualify
- Ages
- 25 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Biologically female (assigned female at birth, with intact ovaries)
- Aged 25 to 38 years
- Fluent in written and spoken Chinese (Traditional or Simplified) or English
- Has access to an internet-enabled smartphone or computer
- Able to give electronic or written informed consent
Key exclusion criteria (4 listed)
- Currently pregnant or breastfeeding
- Known active, severe psychiatric or cognitive disorder that prevents informed - consent or completing the questionnaire
- History of gynecological cancer
- Currently receiving gonadotoxic chemotherapy or pelvic radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Enabled Fertility CounselingAn interactive AI conversational agent ('Shelby', shecare.ai) providing personalized, culturally tailored fertility education and AMH test interpretation with built-in safety protocols. | Behavioural | Control: Non-AMH with AI-Driven Fertility Education, Intervention: AMH Testing with AI-Enabled Counseling |
| Standard Educational Materials or PDF laboratory reportsProvision of conventional static health education materials via standard medical brochures and/or standard PDF laboratory reports with reference ranges without interactive conversational AI features. | Behavioural | Control: Non-AMH with Standard Educational Website, Intervention: AMH Testing with Static Lab Report |
Primary outcome
Change in Fertility Intentions and Reproductive Planning
Time frame: 2 to 4 weeks post-intervention
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. Laboratory Anti-Müllerian Hormone (AMH) assay values. Raw conversational logs and direct identifying personal data will not be shared to protect participant privacy."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Enabled Fertility Counseling and Standard Educational Materials or PDF laboratory reports in people with Fertility Awareness and Ovarian Reserve, run by City University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wai-Kit MING, PhD (+852 3442-6956, wkming2@cityu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fertility Intentions and Reproductive Planning (time frame: 2 to 4 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.