跳至主要内容
临床试验/NCT07087171
NCT07087171招募中不适用

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

Instituto Valenciano de Infertilidade de Lisboa2 个研究点 分布在 1 个国家目标入组 774 人开始时间: 2025年6月11日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
774
试验地点
2
主要终点
9-month conversion rate

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

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

干预措施: Artificial intelligence-Machine learning report with accurate personalized probabilities of having a live birth rate (Other)

结局指标

主要结局

9-month conversion rate

时间窗: 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

次要结局

  • 3-month MAR conversion(From enrollment until 3 months after)
  • 6-month MAR conversion(From enrollment until 6 month after)

研究者

发起方
Instituto Valenciano de Infertilidade de Lisboa
申办方类型
Network
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验