The Aim of This Study is to Determine if Oocyte Sorting for Group Culture Using an Artificial Intelligence Image Analysis Tool (MagentaTM) Increases the Usable Blastocyst Yield and Subsequent Pregnancy in Patients Undergoing IVF (NiOS)

July 23, 2024 updated by: Ovation Fertility

NiOS (Non-Invasive Oocyte Sorting) Study

The aim of this study is to determine if oocyte sorting for group culture using an artificial intelligence image analysis tool (MagentaTM) increases the usable blastocyst yield and subsequent pregnancy in patients undergoing IVF.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction Magenta™ is a software image analysis tool developed by Future Fertility that allows personalized reproductive prediction for each oocyte (egg cell) analyzed. It is a cloud-based software that was developed to assess the probability of an oocyte to fertilize and develop into a blastocyst (ball of rapidly dividing cells that will become an embryo). It is a non-invasive image analysis tool that uses artificial intelligence (AI) to predict outcomes based on a single 2-D image of a mature oocyte (denuded oocyte) prior to freezing or sperm injection (ICSI). Magenta™ was designed and built specifically to analyze oocytes in the IVF lab. It was created based on more than 20,000 images of oocytes and their known reproductive outcomes. It is an image analysis neural network that can identify important signals beyond the limited morphological features detected by embryologists, like facial recognition systems in use today. Without the development of this AI tool, there are no standard assessments for oocyte quality within the IVF process. The use of Magenta™ in this study is investigational.

In standard IVF laboratories, oocytes can undergo their developmental period alone (single culture) or be grouped with other oocytes during this time (group culture). Research has shown that group culture has some developmental advantages over single culture.

What is this study for? At the moment, there is no standard method to sort oocytes into groups for their developmental period. Currently, oocytes are sorted in a random manner. We hope that Magenta™ analysis will provide information at this early stage of development and inform a better way to sort oocytes into groups (from lowest to highest quality). The objective of this research study is to compare sorting the oocytes randomly to utilizing the MagentaTM tool for oocyte assessment to determine which oocytes should be grouped together. Study participants will be randomly assigned to the control (random sorting) or the study (Magenta™ analysis) groups at the time of oocyte retrieval. You have an equal chance of being assigned to either group. We intend to enroll 450 subjects.

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • Ovation Fertility Las Vegas
        • Contact:
        • Principal Investigator:
          • Matthew VerMilyea, PhD
    • Ohio
      • Cincinnati, Ohio, United States, 45209
        • Recruiting
        • Ovation Fertility Cincinnati
        • Contact:
        • Principal Investigator:
          • Matthew VerMilyea, PhD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Ovation Fertility - Nashville
        • Contact:
        • Principal Investigator:
          • Matthew VerMilyea, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients seeking IVF treatment

Description

Inclusion Criteria:

  • Fresh MII oocytes
  • ICSI cycles with patient's or donor's sperm
  • Patient's or donor's oocytes
  • Full IVF cycle information available (including total number of oocytes retrieved, total MII oocytes, fertilization, embryo and blastocyst development, as well as ploidy status or implantation results, and 6-7 week ultrasound, if applicable)
  • Good quality images of MII oocytes taken with a specified camera (Basler) and Future Fertility Software
  • Single embryo transfers (SETs) at blastocyst stage.
  • Blastocyst freeze-all cycles

Exclusion Criteria:

  • Severe male factor infertility (<1 million motile), including surgically retrieved sperm.
  • ICSI cycles inseminating in vitro matured (IVM) oocytes
  • Rescue ICSI oocytes (oocytes failed standard IVF and are re-inseminated by ICSI)
  • Low quality images - Poor quality images on day of upload or before unblinding
  • Lack of correlating reproductive outcomes (full IVF lab results not available).
  • Autologous or donor frozen/warmed oocytes
  • Day 3 embryo transfers or cleavage stage embryo freezing
  • Patients with less than 6 mature oocytes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Oocytes with AI
Oocytes assessed by the Magenta software
Other: Magenta AI image analysis tool
MagentaTM is a non-invasive image analysis tool that utilizes artificial intelligence to evaluate 2-dimensional images of denuded mature MII oocytes. The MagentaTM software has been analyzed retrospectively, by Future Fertility. This data displays that a higher MagentaTM score is associated with a higher chance of blastocyst development. Additionally, the MagentaTM software has been validated in a prospective multi-center study, displaying that a higher MagentaTM score correlates to a higher chance of blastocyst development.
Oocytes without AI
Oocytes randomly selected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare blastocyst development rate
Time Frame: 5 to 7 days
Blast Development rates between oocytes (and resulting embryos) that are group cultured according to MagentaTM scores versus oocytes (and resulting embryos group) cultured as per the standard of care following random sorting. Blastocyst development is defined by an embryologist's grading, according to the laboratory's grading system.
5 to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization Rate
Time Frame: 1Day
within each MagentaTM score group and random sorting groups.
1Day
Morphological Blastocyst Quality
Time Frame: 7 days
within each MagentaTM score group and random sorting groups.
7 days
Euploidy Rate
Time Frame: 14 days
within each MagentaTM score group and random sorting groups.
14 days
Pregnancy Rate
Time Frame: 6 weeks
Positive pregnancy test
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ovation Fertility

Collaborators

Future Fertility

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 2, 2027

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OVA-11-2023-TX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Pending results

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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