Infertility (IVF Patients)NCT07087171
AI-Driven Model Impact on Patient Engagement in Medically Assisted Reproduction
An observational study of Infertility (IVF Patients) and Artificial Intelligence (AI), run by Instituto Valenciano de Infertilidade de Lisboa at 1 site in Portugal.
Trial summary
Infertility is a globally significant medical condition, profoundly impacting individuals and couples both emotionally and physically. The multifaceted nature of in vitro fertilization (IVF) treatment demands active patient participation, with engagement playing a pivotal role in treatment success and satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Infertility (IVF Patients), Artificial Intelligence (AI)
- What is being tested?
- Artificial intelligence-Machine learning report with accurate personalized probabilities of having a live birth rate
- How many people
- 774 participants
- Where
- 1 sitePortugal
- Study dates
- 11 Jun 2025to Aug 2026
- Phase
- Observational
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study period will run from December 1, 2024, to December 31, 2025. During the first phase, from December 1, 2024, to May 31, 2025, a retrospective cohort of patients attending their first appointment at IVI Lisboa with a research team member will have received conventional counseling regarding IVF treatment prognosis. In the second phase, from June 1, 2025, to November 30, 2025, a prospective cohort of patients attending their first appointment with the same team will receive AI-based counseling using the Univfy® PreIVF Report.®.
Who may be able to join
- Infertile patients aged 18-45 years
- Patients willing to undergo Medically Assisted Reproduction (heterosexual couples, same-sex female couples and single females undergoing artificial insemination, IVF/ICSI or oocyte donation treatments)
Who cannot join
- Age >45 years
- Patients who are not candidates for IVF/ICSI
- Patients who are menopausal or peri-menopausal
- Patients undergoing Fertility Preservation
- Same-sex couples who will undergo reception of oocytes from partner.
- Patients who decline to be counselled about their probability of having a live birth from IVF/ICSI treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
IVI-RMA Lisboa
Lisbon
Ana R Neves, +351800 180 614, ana.neves@ivirma.com
About this study
Official title: Assessing the Impact of an Artificial Intelligence-Machine Learning Model on Patient Engagement in Medically Assisted Reproduction
Infertility is a globally significant medical condition, profoundly impacting individuals and couples both emotionally and physically. The multifaceted nature of in vitro fertilization (IVF) treatment demands active patient participation, with engagement playing a pivotal role in treatment success and satisfaction. However, suboptimal engagement can lead to challenges such as not initiating treatment, missed appointments, medication errors, dropping out and heightened stress levels, all of which may adversely affect clinical outcomes.
Recent advancements in Artificial Intelligence (AI) and Machine Learning (ML) have revolutionized healthcare, offering innovative solutions for personalized patient care. In IVF, AI-ML models hold the potential to enhance patient engagement by delivering tailored communication, reminders, and educational support, but also improved prognostication by providing personalized and accurate predictions of treatment outcomes. These capabilities enable patients to make more informed decisions and enhance their adherence to treatment protocols.This protocol outlines a prospective evaluation of an AI-ML model, specifically the Univfy PreIVF report, developed to improve patient engagement in IVF care. Recently, a retrospective, multicenter study reported improved IVF utilization rates among patients counselled using the Univfy PreIVF Report. The current study will prospectively assess the model's effectiveness in addressing individual patient needs and creating a supportive treatment environment. Specifically, this study will measure adherence to providers' recommendation of treatment protocols. By analyzing the impact of these interventions, this research aims to provide robust evidence for the integration of AI-ML technologies in reproductive medicine, paving the way for broader implementation and improved patient outcomes.
- Being tested
- Artificial intelligence-Machine learning report with accurate personalized probabilities of having a live birth rate
- Keywords
- IVF, Artificial intelligence, counselling, Conversion rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligence-Machine learning report with accurate personalized probabilities of having a live birth rateOther
Patients included in the prospective arm will receive the Univfy® PreIVF Report with their accurate personalized probabilities of having a live birth rate (Univfy®) together with a medical explanation by their physician
| Study group | Role | What they receive |
|---|---|---|
| Conventional counselling group | A retrospective cohort of patients who underwent their new patient visit with one of the doctors participating in the study between December 2024 and June 2025 will be analyzed. | |
| AI-based counselling group | A prospective cohort of patients undergoing their NPV with one of the doctors participating in the study will receive an artificial intelligence-machine learning report with their accurate personalized probabilities of having a live birth rate together with a medical explanation by their physician Receives: Other: Artificial intelligence-Machine learning report with accurate personalized probabilities of having a live birth rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
9-month conversion rate
9-month conversion, with conversion being defined as the first usage of Medically Assisted Reproduction (MAR) following a new patient visit
Measured: From enrollment until 9 months after
Secondary outcomes (2)
3-month MAR conversion
3-month conversion rate
Measured: From enrollment until 3 months after
6-month MAR conversion
6-month conversion
Measured: From enrollment until 6 month after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start11 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility (IVF Patients)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 774 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidade de Lisboa
- Sponsor type
- Research network
- Collaborators
- Univfy Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087171
- Sponsor's protocol ID
- 2412-LIS-233-AN
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of an Artificial Intelligence-Machine Learning Model on Patient Engagement in Medically Assisted Reproduction
- ClinicalTrials.gov ID
- NCT07087171
- Acronym / sponsor ID
- 2412-LIS-233-AN
- Keywords
- IVF, Artificial intelligence, counselling, Conversion rate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 774 participants (estimated)
- Lead sponsor
- Instituto Valenciano de Infertilidade de LisboaResearch network
- Collaborators
- Univfy Inc.
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 25 Jul 2025 (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.
Infertility is a globally significant medical condition, profoundly impacting individuals and couples both emotionally and physically. The multifaceted nature of in vitro fertilization (IVF) treatment demands active patient participation, with engagement playing a pivotal role in treatment success and satisfaction. However, suboptimal engagement can lead to challenges such as not initiating treatment, missed appointments, medication errors, dropping out and heightened stress levels, all of which may adversely affect clinical outcomes.
Recent advancements in Artificial Intelligence (AI) and Machine Learning (ML) have revolutionized healthcare, offering innovative solutions for personalized patient care. In IVF, AI-ML models hold the potential to enhance patient engagement by delivering tailored communication, reminders, and educational support, but also improved prognostication by providing personalized and accurate predictions of treatment outcomes. These capabilities enable patients to make more informed decisions and enhance their adherence to treatment protocols.This protocol outlines a prospective evaluation of an AI-ML model, specifically the Univfy PreIVF report, developed to improve patient engagement in IVF care. Recently, a retrospective, multicenter study reported improved IVF utilization rates among patients counselled using the Univfy PreIVF Report. The current study will prospectively assess the model's effectiveness in addressing individual patient needs and creating a supportive treatment environment. Specifically, this study will measure adherence to providers' recommendation of treatment protocols. By analyzing the impact of these interventions, this research aims to provide robust evidence for the integration of AI-ML technologies in reproductive medicine, paving the way for broader implementation and improved patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional counselling group | – | –A retrospective cohort of patients who underwent their new patient visit with one of the doctors participating in the study between December 2024 and June 2025 will be analyzed. |
| AI-based counselling group | – | Other: Artificial intelligence-Machine learning report with accurate personalized probabilities of having a live birth rateA prospective cohort of patients undergoing their NPV with one of the doctors participating in the study will receive an artificial intelligence-machine learning report with their accurate personalized probabilities of having a live birth rate together with a medical explanation by their physician |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study period will run from December 1, 2024, to December 31, 2025. During the first phase, from December 1, 2024, to May 31, 2025, a retrospective cohort of patients attending their first appointment at IVI Lisboa with a research team member will have received conventional counseling regarding IVF treatment prognosis. In the second phase, from June 1, 2025, to November 30, 2025, a prospective cohort of patients attending their first appointment with the same team will receive AI-based counseling using the Univfy® PreIVF Report.®.
Key inclusion criteria (2 listed)
- Infertile patients aged 18-45 years
- Patients willing to undergo Medically Assisted Reproduction (heterosexual couples, same-sex female couples and single females undergoing artificial insemination, IVF/ICSI or oocyte donation treatments)
Key exclusion criteria (6 listed)
- Age >45 years
- Patients who are not candidates for IVF/ICSI
- Patients who are menopausal or peri-menopausal
- Patients undergoing Fertility Preservation
- Same-sex couples who will undergo reception of oocytes from partner.
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 |
|---|---|---|
| Artificial intelligence-Machine learning report with accurate personalized probabilities of having a live birth ratePatients included in the prospective arm will receive the Univfy® PreIVF Report with their accurate personalized probabilities of having a live birth rate (Univfy®) together with a medical explanation by their physician | Other | AI-based counselling group |
Primary outcome
9-month conversion rate
Time frame: From enrollment until 9 months after
9-month conversion, with conversion being defined as the first usage of Medically Assisted Reproduction (MAR) following a new patient visit
2 secondary outcomes
3-month MAR conversion
Time frame: From enrollment until 3 months after
6-month MAR conversion
Time frame: From enrollment until 6 month after
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 23 Feb 2026.
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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?
An observational study of Infertility (IVF Patients) and Artificial Intelligence (AI), run by Instituto Valenciano de Infertilidade de Lisboa at 1 site in Portugal.
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 2 inclusion and 6 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 23 Feb 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 Portugal. 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 Ana R Neves, MD, PhD (+351 800 180 614, ana.neves@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
9-month conversion rate (time frame: From enrollment until 9 months after). 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 23 Feb 2026.