AI-TOP Study Artificial Intelligence for Trigger Optimization.

Sponsor
Fundacion Dexeus
Study ID
NCT07515118
Status
Recruiting
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Conditions

  • Artificial Intelligence
  • Infertility
  • Ovarian Stimulation

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 42 Years
Healthy Volunteers
Not accepted

Interventions

  • STIMAI®. — DEVICE
    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.
  • Routine clinical management — OTHER
    As soon as 2-3 follicles of 17 mm are detected, the physician will determine the timing of ovulation triggering based on clinical judgment.

Study Details

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.

Key Dates

First listed
Apr 7, 2026
Start date
Apr 8, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
644 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AI Algorithm
    Trigger decisions trigger will be made by the physician assisted by AI guidance.
  • Active Comparator: Routine clinical management
    Following routine clinical management with ovulation trigger decisions made by the physician alone,

Primary Outcome Measure

MII oocytes [ Time Frame: Day of pickup approx. 34-36 hours after ovulation trigger. ]

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