Recruiting

Oocyte Sorting

Sponsor:

Ovation Fertility

Code:

NCT06521372

Conditions

Infertility Primary

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Magenta AI image analysis tool

Study Details

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

Study ID

NCT06521372

Start date

Jan 1, 2024

Status verified date

Jul, 2024

Completion date

Jan 2, 2027

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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 Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

Oocytes with AI

Oocytes assessed by the Magenta software

Oocytes without AI

Oocytes randomly selected

Interventions

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.

Primary outcome measure

  • Compare blastocyst development rate [ Time Frame: 5 to 7 days ]

Central Contacts and Locations

Locations

Ovation Fertility Las Vegas

Recruiting

Las Vegas, Nevada, United States, 89113

Contacts

Matthew VerMilyea, PhD

512-980-0310tex@ovationfertility.com

Principal Investigator:

Matthew VerMilyea, PhD

Ovation Fertility Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45209

Contacts

Matthew VerMilyea, PhD

512-980-0310tex@ovationfertility.com

Principal Investigator:

Matthew VerMilyea, PhD

Ovation Fertility - Nashville

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Matthew VerMilyea, PhD

512-980-0310tex@ovationfertility.com

Principal Investigator:

Matthew VerMilyea, PhD

More Information

Sponsor

Ovation Fertility

Last update posted

Jul 26, 2024

Last verified

Jul, 2024

Keywords

  • Artificial Intelligence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ovation Fertility on 2024-07-26.