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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

ConditionInfertility Primary
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorOvation Fertility

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

Patients seeking IVF treatment

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Magenta AI image analysis tool

    Other intervention

    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.

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: Oocytes with AI1 intervention
Group B: Oocytes without AI0 interventions

Trial outcomes

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.

Time frame
5 to 7 days

Secondary outcomes

1

Fertilization Rate

within each MagentaTM score group and random sorting groups.

Time frame
1Day
2

Morphological Blastocyst Quality

within each MagentaTM score group and random sorting groups.

Time frame
7 days
3

Euploidy Rate

within each MagentaTM score group and random sorting groups.

Time frame
14 days
4

Pregnancy Rate

Positive pregnancy test

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ovation Fertility

Lead sponsor

Future Fertility Inc.

Collaborator

Source ClinicalTrials.gov
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