- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_CONTROL
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
|---|
|
IVF patients using preimplantation genetic testing
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sustained Implantation Rate
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Polygenic Score correlation with Embryo Morphology
Délai: Through study completion (3 years)
|
Comparison of Disease Risk Scores According to Embryo Morphological Grades |
Through study completion (3 years)
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Pro04078746
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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