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NCT03879265 Clinical Trial

Validation of a NICS Method Using the Culture Medium

Chromosome Abnormality Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03879265
Other study ID # IBB11
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date January 20, 2020

Study information
Verified date August 2020
Source Instituto Bernabeu
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date January 20, 2020
Est. primary completion date December 1, 2019
Accepts healthy volunteers
Gender Male
Age group 19 Years to 49 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Noninvasive chromosome screening
Screening based on MALBAC-NGS technology

Locations
Country Name City State
Spain Instituto Bernabeu Alicante

Sponsors (1)
Lead Sponsor Collaborator
Instituto Bernabeu

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of Mosaicism Presence of mosaicism At Day 5-6 after FIV
Primary Quality value of NICS DLRS Quality value of noninvasive chromosome screening (NICS) derivative Log Ratio Spread (DLRS) At Day 5-6 after FIV
See also
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