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 volunteersQualifiers
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
Cohort
Other
Treatments tested in this trial
Artificial intelligence-Machine learning report with accurate personalized probabilities of having a live birth rate
Other interventionPatients 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
Trial outcomes
Primary outcomes
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
Secondary outcomes
3-month MAR conversion
3-month conversion rate
6-month MAR conversion
6-month conversion
Sponsors and contacts
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Instituto Valenciano de Infertilidade de Lisboa
Lead sponsor
Univfy Inc.
Collaborator