Infertility PrimaryNiOSNCT06521372
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
An observational study of Infertility Primary, run by Ovation Fertility at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infertility Primary
- What is being tested?
- Magenta AI image analysis tool
- How many people
- 450 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2024to 2 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients seeking IVF treatment
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Ovation Fertility Cincinnati
Cincinnati, Ohio, 45209
Matthew VerMilyea, PhD, 512-980-0310, tex@ovationfertility.com
Matthew VerMilyea, PhD
- Recruiting
Ovation Fertility Las Vegas
Las Vegas, Nevada, 89113
Matthew VerMilyea, PhD, 512-980-0310, tex@ovationfertility.com
Matthew VerMilyea, PhD
- Recruiting
Ovation Fertility - Nashville
Nashville, Tennessee, 37203
Matthew VerMilyea, PhD, 512-980-0310, tex@ovationfertility.com
Matthew VerMilyea, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Infertility Primary
- Being tested
- Magenta AI image analysis tool
- Keywords
- Artificial Intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magenta AI image analysis toolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Oocytes with AI | Oocytes assessed by the Magenta software Receives: Other: Magenta AI image analysis tool | |
| Oocytes without AI | Oocytes randomly selected |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 to 7 days
Secondary outcomes (4)
Fertilization Rate
within each MagentaTM score group and random sorting groups.
Measured: 1Day
Morphological Blastocyst Quality
within each MagentaTM score group and random sorting groups.
Measured: 7 days
Euploidy Rate
within each MagentaTM score group and random sorting groups.
Measured: 14 days
Pregnancy Rate
Positive pregnancy test
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ovation Fertility
- Sponsor type
- University, hospital or other
- Collaborators
- Future Fertility Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521372
- Sponsor's protocol ID
- OVA-11-2023-TX
- Acronym
- NiOS
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pending results
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NiOS (Non-Invasive Oocyte Sorting) Study
- ClinicalTrials.gov ID
- NCT06521372
- Acronym / sponsor ID
- NiOS / OVA-11-2023-TX
- Conditions
- Infertility Primary
- Keywords
- Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Ovation FertilityUniversity, hospital or other
- Collaborators
- Future Fertility Inc.
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oocytes with AI | – | Other: Magenta AI image analysis toolOocytes assessed by the Magenta software |
| Oocytes without AI | – | –Oocytes randomly selected |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients seeking IVF treatment
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magenta AI image analysis toolMagentaTM 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. | Other | Oocytes with AI |
Primary outcome
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.
4 secondary outcomes
Fertilization Rate
Time frame: 1Day
Morphological Blastocyst Quality
Time frame: 7 days
Euploidy Rate
Time frame: 14 days
Pregnancy Rate
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: Undecided. Pending results
Related trials for Infertility Primary
Not yet recruitingObservational study
ERA in Young Primary Infertile RIF Patients
Recurrent Implantation Failure
Not yet recruitingPhase 3
Progesterone Luteal Support in Unexplained Infertility Management
Infertility, Female Infertility
Not yet recruiting
Ovarian Tissue Allo-transplantation
Ovarian Failure, Ovarian Insufficiency
Active, not recruitingObservational study
Will Autologous Platelet Rich Plasma Able To Restore Ovarian Function?
Infertility, IVF
RecruitingObservational study
Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation
Cystic Fibrosis, Congenital Bilateral Absence of Vas Deferens
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility Primary, run by Ovation Fertility at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare blastocyst development rate (time frame: 5 to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.