Polygenic Embryo Selection

September 21, 2026 updated by: Nucleus Genomics Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who decline research use of data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: CASE_CONTROL
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
IVF patients using preimplantation genetic testing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 8-12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Polygenic Score correlation with Embryo Morphology
Time Frame: Through study completion (3 years)

Comparison of Disease Risk Scores According to Embryo Morphological Grades
Through study completion (3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nucleus Genomics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro04078746

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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