AI-Driven Model Impact on Patient Engagement in Medically Assisted Reproduction

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorInstituto Valenciano de Infertilidade de Lisboa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Age >45 years

Patients who are not candidates for IVF/ICSI

Patients who are menopausal or peri-menopausal

Patients undergoing Fertility Preservation

Trial 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.®.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Artificial intelligence-Machine learning report with accurate personalized probabilities of having a live birth rate

    Other intervention

    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

Treatment groups

774 Participants
are divided into 2 treatment groups
Group A: Conventional counselling group0 interventions
Group B: AI-based counselling group1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From enrollment until 9 months after

Secondary outcomes

1

3-month MAR conversion

3-month conversion rate

Time frame
From enrollment until 3 months after
2

6-month MAR conversion

6-month conversion

Time frame
From enrollment until 6 month after

Other outcomes

Sponsors and contacts

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