Validation of a NICS Method Using the Culture Medium

August 7, 2020 updated by: Belen Lledo, Instituto Bernabeu

Validation of a Noninvasive Chromosome Screening (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Instituto Bernabeu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 49 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Couples who come to the study center to carry out a PGT-A cycle. Only couples that perform treatment using their own gametes will be selected and where the indication of PGT-A will be able to be advanced maternal age, failure of implantation, repeat abortion, male factor or structural chromosomal alterations.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
No intervention. Couples who come to the study center to carry out a PGT-A cycle will be selected. Only couples that will use their own gametes will be selected and the indication of PGT-A will be advanced maternal age, failure of implantation, repeat abortion, male factor or structural chromosomal alterations. The results of chromosomal status of the embryo will be compared using the NICS and the conventional invasive method (PGT-A).
Diagnostic test: Noninvasive chromosome screening
Screening based on MALBAC-NGS technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Mosaicism
Time Frame: At Day 5-6 after FIV
Presence of mosaicism
At Day 5-6 after FIV
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)
At Day 5-6 after FIV

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Bernabeu

Investigators

  • Principal Investigator: Belén Lledo, PhD, Instituto Bernabeu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2019

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

January 20, 2020

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

March 15, 2019

First Posted (ACTUAL)

March 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2020

Last Update Submitted That Met QC Criteria

August 7, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBB11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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