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Validation of a NICS Method Using the Culture Medium

Validation of a Noninvasive Chromosome Screening (NICS) Method Using the Culture Medium

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03879265
Enrollment
50
Registered
2019-03-18
Start date
2019-02-01
Completion date
2020-01-20
Last updated
2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormality, Chromosome Abnormality

Keywords

Diagnosis, Reproduction, Chromosomal Endowment

Brief summary

This study aims to validate a non-invasive method of chromosomal screening (NICS), based on the Multiple Annealing and Looping Based Amplification Cycles- Next-generation Sequencing (MALBAC-NGS) technology, in order to determine the chromosomal endowment of a blastocyst from the DNA of the embryonic culture medium. The chromosomal status of the embryo from an embryo biopsy of trophoectoderm will be established (usual clinical practice), the chromosomal endowment from the DNA of the embryonic culture medium will be determined, and the results using the NICS and the conventional invasive method (Preimplantation Genetic Testing for Aneuploidy \[PGT-A\]) will be compared.

Interventions

DIAGNOSTIC_TESTNoninvasive chromosome screening

Screening based on MALBAC-NGS technology

Sponsors

Instituto Bernabeu
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
19 Years to 49 Years

Inclusion criteria

* Treatment by oocyte donation or own oocyte nd preimplantation genetic screening of aneuploidies (PGT-A). * Embryonic cryopreservation. * Informed consent signature

Exclusion criteria

* Embryo transfer without embryo freezing * Embryonic block. * Bad embryo quality.

Design outcomes

Primary

MeasureTime frameDescription
Presence of MosaicismAt Day 5-6 after FIVPresence of mosaicism
Quality value of NICS DLRSAt Day 5-6 after FIVQuality value of noninvasive chromosome screening (NICS) derivative Log Ratio Spread (DLRS)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026