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

NCT06521372 | Recruiting

• 1 other identifier: OVA-11-2023-TX
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Infertility Primary

Keywords

Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• Compare blastocyst development rate

  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 Outcomes (4)

• Fertilization Rate

  1Day

• Morphological Blastocyst Quality

  7 days

• Euploidy Rate

  14 days

• Pregnancy Rate

  6 weeks

Study Arms (2)

Oocytes with AI

Oocytes assessed by the Magenta software

Other: Magenta AI image analysis tool

Oocytes without AI

Oocytes randomly selected

Interventions

Magenta AI image analysis tool OTHER

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 with AI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seeking IVF treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ovation Fertility: lead
• Future Fertility Inc.: collaborator

Study Sites (3)

Ovation Fertility Las Vegas

Las Vegas, Nevada, 89113, United States

RECRUITING

Ovation Fertility Cincinnati

Cincinnati, Ohio, 45209, United States

RECRUITING

Ovation Fertility - Nashville

Nashville, Tennessee, 37203, United States

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 26, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 2, 2027
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

US (3)