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Clinical Trials/NCT03879265
NCT03879265
Completed
Not Applicable

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

Instituto Bernabeu1 site in 1 country50 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chromosome Abnormality
Sponsor
Instituto Bernabeu
Enrollment
50
Locations
1
Primary Endpoint
Presence of Mosaicism
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
January 20, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Instituto Bernabeu
Responsible Party
Principal Investigator
Principal Investigator

Belen Lledo

Principal investigator

Instituto Bernabeu

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Presence of Mosaicism

Time Frame: At Day 5-6 after FIV

Presence of mosaicism

Quality value of NICS DLRS

Time Frame: At Day 5-6 after FIV

Quality value of noninvasive chromosome screening (NICS) derivative Log Ratio Spread (DLRS)

Study Sites (1)

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