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AI-TOP Study Artificial Intelligence for Trigger Optimization.

NCT07515118 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 644

Last updated 2026-04-22

No results posted yet for this study

Summary

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.

Conditions

  • Infertility
  • Ovarian Stimulation
  • Artificial Intelligence

Interventions

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.

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.

Sponsors & Collaborators

  • Fundacion Dexeus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-08
Primary Completion
2027-04-30
Completion
2027-09-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07515118 on ClinicalTrials.gov