Polygenic ScoreNCT07841769
Polygenic Embryo Selection
An observational study of Polygenic Score, run by Nucleus Genomics Inc..
Trial summary
This study will evaluate whether IVF success rates after PRS-based embryo selection differ from those after morphology-based embryo selection, and whether polygenic disease risk correlates with embryo morphology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polygenic Score
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Sep 2029
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cases (PRS): IVF patients/couples (intended parents) who elect to use PRS based embryo selection. Controls (Morphology): IVF patients/couples (intended parents) who elect to use morphology based embryo selection.
Who may be able to join
- Age 18 years or older
- Undergoing IVF and PGT at any clinic where Nucleus testing is used.
- Ability to provide informed consent and HIPAA authorization
Who cannot join
- Patients who decline research use of data
About this study
Official title: Prospective Observational Outcome Comparison of Morphology- Versus Polygenic-Based Selection of In Vitro Fertilization-Derived Embryos
This study will evaluate whether IVF success rates after PRS-based embryo selection differ from those after morphology-based embryo selection, and whether polygenic disease risk correlates with embryo morphology.
Read the detailed description
Conventional IVF involves the use of morphological grading, commonly using Gardner scores, to prioritize embryos for transfer. Morphological grading is a well established method to improve implantation rates, with better morphological scored embryos having a higher success than lower scoring embryos. Morphology-based selection is also employed following preimplantation genetic testing for aneuploidy (PGT-A), which is now used in over 60% of all IVF cycles in the United States.
More recently, polygenic scoring (PRS) of embryos has been introduced to provide additional information on disease risks and trait probabilities, allowing patients to utilize an alternative method of embryo selection. While there is no prospective study evaluating the utility of PRS, longitudinal studies on over 20,000 sibling pairs and on millions of adults have demonstrated significant disease risk reduction.
One common concern over the use of PRS in place of morphology based selection is the potential impact of implantation and delivery rates. For example, in some cases, the embryo with the lowest risk of a disease may not be the best morphology in the cohort of embryos available for transfer. The question of whether genetic based selection results in lower success rates than morphology based selection has not been evaluated in a prospective observational study. Some retrospective data exist in the context of sex selection. For example, patients using PGT-A may decide to transfer an embryo with their preferred sex (male or female) instead of choosing based on morphology alone. One such study indicated no significant difference in delivery rates between sex and morphology based selection. While this outcome remains surprising to many, one factor that is not always considered is that genetic selection does not always lead to transferring an embryo with the worst morphology. However, similar studies have not been published to corroborate these findings.
This study will evaluate whether IVF success rates after PRS based embryo selection are different from morphology based embryo selection and whether polygenic disease risk is correlated with embryo morphology.
- Conditions
- Polygenic Score
- Keywords
- Polygenic risk scoring, in vitro fertilization, embryo selection, embryo morphology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IVF patients using preimplantation genetic testing | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Implantation Rate
Ongoing pregnancy rate per embryo transfer at the time of discharge from IVF care
Measured: From enrollment to the end of treatment at 8-12 weeks
Secondary outcomes (1)
Polygenic Score correlation with Embryo Morphology
Comparison of Disease Risk Scores According to Embryo Morphological Grades
Measured: Through study completion (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polygenic ScoreStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nucleus Genomics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841769
- Sponsor's protocol ID
- Pro04078746
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Outcome Comparison of Morphology- Versus Polygenic-Based Selection of In Vitro Fertilization-Derived Embryos
- ClinicalTrials.gov ID
- NCT07841769
- Acronym / sponsor ID
- Pro04078746
- Conditions
- Polygenic Score
- Keywords
- Polygenic risk scoring, in vitro fertilization, embryo selection, embryo morphology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Nucleus Genomics Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 25 Sep 2026 (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.
This study will evaluate whether IVF success rates after PRS-based embryo selection differ from those after morphology-based embryo selection, and whether polygenic disease risk correlates with embryo morphology.
Detailed description
Conventional IVF involves the use of morphological grading, commonly using Gardner scores, to prioritize embryos for transfer. Morphological grading is a well established method to improve implantation rates, with better morphological scored embryos having a higher success than lower scoring embryos. Morphology-based selection is also employed following preimplantation genetic testing for aneuploidy (PGT-A), which is now used in over 60% of all IVF cycles in the United States.
More recently, polygenic scoring (PRS) of embryos has been introduced to provide additional information on disease risks and trait probabilities, allowing patients to utilize an alternative method of embryo selection. While there is no prospective study evaluating the utility of PRS, longitudinal studies on over 20,000 sibling pairs and on millions of adults have demonstrated significant disease risk reduction.
One common concern over the use of PRS in place of morphology based selection is the potential impact of implantation and delivery rates. For example, in some cases, the embryo with the lowest risk of a disease may not be the best morphology in the cohort of embryos available for transfer. The question of whether genetic based selection results in lower success rates than morphology based selection has not been evaluated in a prospective observational study. Some retrospective data exist in the context of sex selection. For example, patients using PGT-A may decide to transfer an embryo with their preferred sex (male or female) instead of choosing based on morphology alone. One such study indicated no significant difference in delivery rates between sex and morphology based selection. While this outcome remains surprising to many, one factor that is not always considered is that genetic selection does not always lead to transferring an embryo with the worst morphology. However, similar studies have not been published to corroborate these findings.
This study will evaluate whether IVF success rates after PRS based embryo selection are different from morphology based embryo selection and whether polygenic disease risk is correlated with embryo morphology.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVF patients using preimplantation genetic testing | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cases (PRS): IVF patients/couples (intended parents) who elect to use PRS based embryo selection. Controls (Morphology): IVF patients/couples (intended parents) who elect to use morphology based embryo selection.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Undergoing IVF and PGT at any clinic where Nucleus testing is used.
- Ability to provide informed consent and HIPAA authorization
Key exclusion criteria (1 listed)
- Patients who decline research use of data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sustained Implantation Rate
Time frame: From enrollment to the end of treatment at 8-12 weeks
Ongoing pregnancy rate per embryo transfer at the time of discharge from IVF care
1 secondary outcome
Polygenic Score correlation with Embryo Morphology
Time frame: Through study completion (3 years)
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 25 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Polygenic Score, run by Nucleus Genomics Inc..
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Implantation Rate (time frame: From enrollment to the end of treatment at 8-12 weeks). 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 25 Sep 2026.