Clinical trial NCT06521372: 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
Official title: NiOS (Non-Invasive Oocyte Sorting) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility Primary
Keywords: Artificial Intelligence
Lead sponsor: Ovation Fertility
Sponsor class: OTHER
Collaborators: name: Future Fertility
First posted: 2024-07-26
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seeking IVF treatment

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare blastocyst development rate
timeFrame: 5 to 7 days
Secondary outcomes:
measure: Fertilization Rate
timeFrame: 1Day
measure: Morphological Blastocyst Quality
timeFrame: 7 days
measure: Euploidy Rate
timeFrame: 14 days
measure: Pregnancy Rate
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Ovation Fertility Las Vegas
state: Nevada
city: Cincinnati
country: United States
facility: Ovation Fertility Cincinnati
state: Ohio
city: Nashville
country: United States
facility: Ovation Fertility - Nashville
state: Tennessee
Study officials:
References: