- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07841769
Polygenic Embryo Selection
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
IVF patients using preimplantation genetic testing
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sustained Implantation Rate
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Polygenic Score correlation with Embryo Morphology
Tidsramme: Through study completion (3 years)
|
Comparison of Disease Risk Scores According to Embryo Morphological Grades |
Through study completion (3 years)
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Pro04078746
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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