Health TrialsbyHealthPanel

AI-TOP Study Artificial Intelligence for Trigger Optimization.

ConditionsInfertilityOvarian StimulationArtificial Intelligence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorFundacion Dexeus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Undergoing COS for IVF with autologous oocytes, oocyte donation and elective fertility preservation with all monitoring USS (ultrasound scan) conducted at our centers.

Disqualifiers

Medically indicated fertility preservation

Inability to attend clinic visits for monitoring.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    As soon as 2-3 follicles of 17 mm are detected, the physician will determine the timing of ovulation triggering based on clinical judgment.

Treatment groups

644 Participants
are divided into 2 treatment groups
Group A: AI AlgorithmExperimental treatment 1 intervention
Group B: Routine clinical managementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

MII oocytes

Number of MII oocytes retrieved at oocyte pickup.

Time frame
Day of pickup approx. 34-36 hours after ovulation trigger.

Secondary outcomes

1

Distribution of retrieval procedures during the week.

: The pattern or spread of oocyte retrieval procedures across the days of the week during an IVF cycle.

Time frame
Assessed at the end of the stimulation cycle, once the retrieval schedule is completed. approx. 34-36 hours after ovulation trigger.
2

Number of COCs

The total number of oocytes surrounded by cumulus cells retrieved during the oocyte pick-up procedure, reflecting ovarian response to stimulation.

Time frame
Measured on the day of oocyte retrieval. approx. 34-36 hours after ovulation trigger.
3

Length of stimulation (days)

The total number of days a patient receives gonadotropins for controlled ovarian stimulation before triggering ovulation.

Time frame
From the first day of stimulation until the day the ovulation trigger is administered. Up to 8-15 days
4

FORT (pre-ovulatory follicles on trigger day/AFC)

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.

Time frame
AFC is measured at baseline (cycle day 2-3); pre-ovulatory follicles are counted on trigger day. Up to 8-15 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundacion Dexeus

Lead sponsor

Source ClinicalTrials.gov
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