NCT04255615

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Feb 2020Sep 2029

First Submitted

Initial submission to the registry

February 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

February 12, 2020

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

9 years

First QC Date

February 3, 2020

Last Update Submit

December 17, 2025

Conditions

Keywords

Artificial Intelligence

Outcome Measures

Primary Outcomes (2)

  • Number of baseline antral follicle count

    To assess the accuracy and feasibility of using our artificial intelligence tool to assess antral follicle count, an indicator of baseline ovarian reserve, at time of baseline ultrasound for ART compared to qAVCantral and manual follicle counts to number of total oocytes retrieved.

    Baseline

  • Number of retrieved oocytes

    To assess the accuracy and feasibility of using our artificial intelligence tool

    2 weeks

Secondary Outcomes (4)

  • Number of mature oocytes

    2 weeks

  • Number of multiple gestation

    approximately 6- 8 weeks

  • Number of clinical intrauterine pregnancies IVF

    approximately 6- 8 weeks

  • Number of clinical intrauterine pregnancies OI

    Approximately 6- 8 weeks

Study Arms (1)

3D Ultrasound with AI

OTHER

AI tool to assess antral follicle count using 3 D Ultrasound

Other: AI to analyze 3 D ultrasound

Interventions

AI to assess 3 D ultrasound to assess antral follicle count

Also known as: z
3D Ultrasound with AI

Eligibility Criteria

Age18 Years - 89 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemales undergoing IVF and their partners
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Nikica Zaninovic, PHD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikica Zaninovic, PhD

CONTACT

Rodriq Stubbs, NP

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 5, 2020

Study Start

February 12, 2020

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

September 30, 2029

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations