Recruiting

Artificial Intelligence

Sponsor:

Weill Medical College of Cornell University

Code:

NCT04255615

Conditions

Infertility

in Vitro Fertilization (IVF)

ART

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

AI to analyze 3 D ultrasound

Study Details

Brief summary:

The use of machine learning techniques using an artificial intelligence tool is proposed to analyze clinical data to predict best possible IVF/ART outcomes. This tool has been utilized to accurately predict embryo quality here at Cornell. Utilizing this tool to assess objective clinical findings and predict outcomes of assisted reproductive techniques is sought, with the ultimate goal of an automated tool to reduce implicit physician bias. Within this goal, using this tool to objectively and accurately assess baseline ovarian reserve at the start of an ART cycle is proposed, using 3D sonography to image the ovary and artificial intelligence tool to objectively identify baseline antral follicle counts.

Conditions

Infertility

in Vitro Fertilization (IVF)

ART

Study ID

NCT04255615

Start date

Feb 12, 2020

Status verified date

Dec, 2025

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • All patients undergoing ovarian stimulation (including OI and IVF cycles)
  • Treatment for fresh embryo transfer and cryopreservation of oocytes or embryos upfront
  • Healthy male partners of the female subjects who agree to be part of the study.

Exclusion Criteria:

  • None

Study Design

Enrollment

4000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: 3D Ultrasound with AI

AI tool to assess antral follicle count using 3 D Ultrasound

Interventions

AI to analyze 3 D ultrasound

AI to assess 3 D ultrasound to assess antral follicle count

Primary outcome measure

  • Number of baseline antral follicle count [ Time Frame: Baseline ]
  • Number of retrieved oocytes [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Nikica Zaninovic, PhD

646-962-2764nizanin@med.cornell.edu

Rodriq Stubbs, NP

646-962-3276res2011@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Nikica Zaninovic, PhD

646-962-2764nizanin@med.cornell.edu

Rodriq Stubbs, NP

646-962-3276res2011@med.cornell.edu

Principal Investigator:

Nikica Zaninovic, PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Keywords

  • Artificial Intelligence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-12-24.