Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07515118

AI-TOP Study Artificial Intelligence for Trigger Optimization.

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dexeus Mujer Sabadell, Sabadell, Barcelona, Spain

Loading trial locations.

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. MII oocytes

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

    Number of MII oocytes retrieved at oocyte pickup.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Fundacion Dexeus

Other

Registry information

Official study title

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

Acronym: AI-TOP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.