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Recruiting Not applicable NCT07515118

AI-TOP Study Artificial Intelligence for Trigger Optimization.

No applicable phase (e.g. observational)
Conditions: Infertility Ovarian Stimulation Artificial Intelligence

Sponsor: Fundacion Dexeus

trial.available_in: БГ
Overview
To evaluate, in a randomized controlled trial, whether AI-guided monitoring and ovulation triggering leads to clinical outcomes comparable to those achieved through physician-led decision-making in patients undergoing ovarian stimulation for IVF.
Description
Assisted Reproductive Technology is undergoing a major transformation with the introduction of artificial intelligence (AI), which is reshaping how medical treatments are carried out. In IVF, one of the persistent challenges has been maximizing the number of oocytes retrieved while efficiently managing clinical workload-particularly by reducing weekend procedures-without compromising outcomes. Although a patient's response may vary between cycles, evidence shows that adjusting the trigger day by one day does not significantly affect clinical results, enabling more flexible scheduling. AI enables a shift from standardized protocols to personalized treatments, improving clinical outcomes, streamlining processes and enhancing operational efficiency. Recent research shows that AI-based models can optimize ovarian stimulation, improve trigger-day selection, and increase the number of fertilized oocytes compared to decisions made solely by physicians. AI algorithms have also accurately predicted the number of oocytes retrieved, contributing to more effective protocols and higher live birth rates. Beyond trigger timing, AI has been shown to improve workflow efficiency in IVF clinics by optimizing monitoring schedules and balancing clinical workload without negatively affecting cycle outcomes. Based on this growing evidence, a randomized controlled trial was designed to compare clinical outcomes of controlled ovarian stimulation when trigger and retrieval decisions are made solely by the physician versus when the physician is assisted by AI guidance.
Who can participate
Inclusion Criteria: * Undergoing COS for IVF with autologous oocytes, oocyte donation and elective fertility preservation with all monitoring USS (ultrasound scan) conducted at our centers. Exclusion Criteria: * Medically indicated fertility preservation * Inability to attend clinic visits for monitoring.
Interventions
STIMAI®.
DEVICE
Routine clinical management
OTHER
Locations 5
Spain (5)
Hospital Universitario Quiron Dexeus
Barcelona
Nikolaos P Polyzos, MD PhD
Dexeus Mujer Reus
Reus , Tarragona
NOT_YET_RECRUITING
Josep Gonzalo, MD
Dexeus Mujer Sabadell
Sabadell , Barcelona
NOT_YET_RECRUITING
Dexeus Mujer Sant Cugat
Sant Cugat del Vallès , Barcelona
NOT_YET_RECRUITING
Dexeus Mujer Tarragona
Tarragona
NOT_YET_RECRUITING
Josep Gonzalo, MD
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Maximum age
42 Years
Healthy volunteers
No
Start date
08.04.2026
Completion date
01.09.2027
Registry ID
NCT07515118
Source
clinicaltrials.gov
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