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Completed

NCT Number: NCT03879265

Validation of a NICS Method Using the Culture Medium

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.

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Key information

Conditions

Chromosome Abnormality Abnormality Chromosome Aberrations Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year–49 year

Sex eligibility

Male

Study type

Observational

Primary location

Instituto Bernabeu

Alicante, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Noninvasive chromosome screening

Diagnostic Test

Screening based on MALBAC-NGS technology

Primary outcomes

  1. Presence of Mosaicism

    Time frame: At Day 5-6 after FIV

    Presence of mosaicism

  2. 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)

Sponsors and collaborators

Lead sponsor

Instituto Bernabeu

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 18, 2019
Registry last updated
Aug 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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