AI-TOP Study Artificial Intelligence for Trigger Optimization. (AI-TOP)

April 21, 2026 updated by: Fundacion Dexeus

An Artificial Intelligence Based Approach for Selecting the Optimal Day for Triggering.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

644

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • Recruiting
        • Hospital Universitario Quiron Dexeus
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nikolaos P Polyzos, MD PhD
        • Sub-Investigator:
          • Valeria Donno, MD
        • Sub-Investigator:
          • Mariana B Miguens, MD
        • Sub-Investigator:
          • Gerarda Gaeta, MD
      • Tarragona, Spain, 43206
        • Not yet recruiting
        • Dexeus Mujer Tarragona
        • Contact:
        • Principal Investigator:
          • Josep Gonzalo, MD
    • Barcelona
      • Sabadell, Barcelona, Spain
        • Not yet recruiting
        • Dexeus Mujer Sabadell
        • Contact:
        • Principal Investigator:
          • Ainhoa Coco, MD
      • Sant Cugat del Vallès, Barcelona, Spain, 08195
        • Not yet recruiting
        • Dexeus Mujer Sant Cugat
        • Contact:
        • Principal Investigator:
          • Ainhoa Coco, MD
    • Tarragona
      • Reus, Tarragona, Spain, 43202
        • Not yet recruiting
        • Dexeus Mujer Reus
        • Contact:
        • Principal Investigator:
          • Josep Gonzalo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI Algorithm
Trigger decisions trigger will be made by the physician assisted by AI guidance.
Device: STIMAI®.
The AI algorithm used in this study is STIMAI®. STIMAI® is an artificial intelligence-based software that assists clinicians by providing data-driven insights to optimize the fertility treatment process and support conception. The software is designed as a clinical decision support tool and does not replace the physician's judgment; final clinical decisions will remain under the responsibility of the treating physician The physician will consult the AI application, which predicts the number of MII oocytes for different trigger days. If the algorithm recommends triggering today or tomorrow, the physician will choose which option to follow.
Active Comparator: Routine clinical management
Following routine clinical management with ovulation trigger decisions made by the physician alone,
Other: Routine clinical management
As soon as 2-3 follicles of 17 mm are detected, the physician will determine the timing of ovulation triggering based on clinical judgment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MII oocytes
Time Frame: Day of pickup approx. 34-36 hours after ovulation trigger.
Number of MII oocytes retrieved at oocyte pickup.
Day of pickup approx. 34-36 hours after ovulation trigger.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of retrieval procedures during the week.
Time Frame: Assessed at the end of the stimulation cycle, once the retrieval schedule is completed. approx. 34-36 hours after ovulation trigger.
: The pattern or spread of oocyte retrieval procedures across the days of the week during an IVF cycle.
Assessed at the end of the stimulation cycle, once the retrieval schedule is completed. approx. 34-36 hours after ovulation trigger.
Number of COCs
Time Frame: Measured on the day of oocyte retrieval. approx. 34-36 hours after ovulation trigger.
The total number of oocytes surrounded by cumulus cells retrieved during the oocyte pick-up procedure, reflecting ovarian response to stimulation.
Measured on the day of oocyte retrieval. approx. 34-36 hours after ovulation trigger.
Length of stimulation (days)
Time Frame: From the first day of stimulation until the day the ovulation trigger is administered. Up to 8-15 days
The total number of days a patient receives gonadotropins for controlled ovarian stimulation before triggering ovulation.
From the first day of stimulation until the day the ovulation trigger is administered. Up to 8-15 days
FORT (pre-ovulatory follicles on trigger day/AFC)
Time Frame: AFC is measured at baseline (cycle day 2-3); pre-ovulatory follicles are counted on trigger day. Up to 8-15 days
A measure of follicular responsiveness calculated as the number of pre-ovulatory follicles on trigger day divided by the baseline antral follicle count (AFC). It reflects the efficiency of stimulation in growing recruitable follicles.
AFC is measured at baseline (cycle day 2-3); pre-ovulatory follicles are counted on trigger day. Up to 8-15 days
FOI (N COCs/AFC)
Time Frame: AFC measured at baseline; COCs counted on the day of retrieval approx. 34-36 hours after ovulation trigger.
The number of cumulus-oocyte complexes retrieved divided by the baseline antral follicle count (AFC), indicating how effectively baseline follicles resulted in retrieved oocytes.
AFC measured at baseline; COCs counted on the day of retrieval approx. 34-36 hours after ovulation trigger.
Number of visits
Time Frame: Counted from the start of stimulation until the trigger day. up to 8-12 days
The total number of in-clinic monitoring visits required during controlled ovarian stimulation, including ultrasound assessments and blood tests.
Counted from the start of stimulation until the trigger day. up to 8-12 days
Spontaneous ovulation
Time Frame: Detected between the trigger administration and the planned oocyte retrieval. approx. 34-36 hours after ovulation trigger.
Occurrence of unintended follicular rupture before oocyte retrieval, indicating that ovulation happened prior to the scheduled procedure despite monitoring.
Detected between the trigger administration and the planned oocyte retrieval. approx. 34-36 hours after ovulation trigger.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Dexeus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSD-AIG-2025-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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