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NCT Number: NCT07087171

AI-Driven Model Impact 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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 3-month MAR conversion

    Time frame: From enrollment until 3 months after

    3-month conversion rate

  2. 6-month MAR conversion

    Time frame: From enrollment until 6 month after

    6-month conversion

Study contacts

Contact information is provided by the study sponsor or research team.

Ana R Neves, MD, PhD

CONTACT

[email protected]

+351 800 180 614

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidade de Lisboa

Network

Collaborators

  • Univfy Inc.

Registry information

Official study title

Assessing the Impact of an Artificial Intelligence-Machine Learning Model on Patient Engagement in Medically Assisted Reproduction

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2025
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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