search
Back to results

Use of Artificial Intelligence for Clinical Assessment of Assisted Reproductive Techniques and IVF Outcomes (AI in ART)

Primary Purpose

Infertility, in Vitro Fertilization (IVF), ART

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AI to analyze 3 D ultrasound
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility focused on measuring Artificial Intelligence

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Weill Cornell Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

3D Ultrasound with AI

Arm Description

AI tool to assess antral follicle count using 3 D Ultrasound

Outcomes

Primary Outcome Measures

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.
Number of retrieved oocytes
To assess the accuracy and feasibility of using our artificial intelligence tool

Secondary Outcome Measures

Number of mature oocytes
Number of mature oocytes (ART cycles)
Number of multiple gestation
Number of multiple gestation for OI cycles.
Number of clinical intrauterine pregnancies IVF
Clinical intrauterine pregnancies
Number of clinical intrauterine pregnancies OI
Clinical intrauterine pregnancies

Full Information

First Posted
February 3, 2020
Last Updated
March 27, 2023
Sponsor
Weill Medical College of Cornell University
search

1. Study Identification

Unique Protocol Identification Number
NCT04255615
Brief Title
Use of Artificial Intelligence for Clinical Assessment of Assisted Reproductive Techniques and IVF Outcomes
Acronym
AI in ART
Official Title
The Use of Artificial Intelligence for Clinical Assessment of Assisted Reproductive Techniques and IVF Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study will collect prospective data, specifically 3D transvaginal ultrasound of ovaries at time of baseline evaluation at beginning of an ART cycle. All participants will be asked to give written consent to be included in the study. At the time of initial ultrasound that is routinely done on the first day of the ART cycle, the physician performing the ultrasound will use a 3D ultrasound transvaginal probe to perform the ultrasound and capture both 2D and 3D images. 3D ultrasound is performed routinely for patients undergoing ART and is not an investigative procedure, however is not uniformly performed at the time of the baseline ultrasound. As per standard practice, the baseline antral follicle count will be documented by the performing physician, as well as a 3D image saved to be analyzed later using AI. Information about the medical history, treatment and outcomes will be collected as part of the study. Data maintained in the medical record as a result of standard of care monitoring for IVF and IUI will also be used for this study. This will include semen analysis (male partners if applicable) and pregnancy outcomes. For male partners, the semen analysis record will be part of the fertility history and semen analysis will be performed as standard of care with semen processing for fertilization. Additional data related to the treatment and outcomes will be collected from the medical record from the time of consent through the end of the treatment (including pregnancy outcomes). The time commitment for subjects may take up to 1 month (time from consent signing to 3D ultrasound) and to the time of delivery if pregnant (up to 9 months). No further procedures will be performed in the study group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, in Vitro Fertilization (IVF), ART
Keywords
Artificial Intelligence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3D Ultrasound with AI
Arm Type
Other
Arm Description
AI tool to assess antral follicle count using 3 D Ultrasound
Intervention Type
Other
Intervention Name(s)
AI to analyze 3 D ultrasound
Other Intervention Name(s)
z
Intervention Description
AI to assess 3 D ultrasound to assess antral follicle count
Primary Outcome Measure Information:
Title
Number of baseline antral follicle count
Description
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.
Time Frame
Baseline
Title
Number of retrieved oocytes
Description
To assess the accuracy and feasibility of using our artificial intelligence tool
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Number of mature oocytes
Description
Number of mature oocytes (ART cycles)
Time Frame
2 weeks
Title
Number of multiple gestation
Description
Number of multiple gestation for OI cycles.
Time Frame
approximately 6- 8 weeks
Title
Number of clinical intrauterine pregnancies IVF
Description
Clinical intrauterine pregnancies
Time Frame
approximately 6- 8 weeks
Title
Number of clinical intrauterine pregnancies OI
Description
Clinical intrauterine pregnancies
Time Frame
Approximately 6- 8 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Females undergoing IVF and their partners
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikica Zaninovic, PHD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Artificial Intelligence for Clinical Assessment of Assisted Reproductive Techniques and IVF Outcomes

We'll reach out to this number within 24 hrs