Validation of a NICS Method Using the Culture Medium

NCT ID: NCT03879265

Last Updated: 2020-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-01-20

Brief Summary

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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.

Detailed Description

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Conditions

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Chromosome Abnormality Abnormality

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

Noninvasive chromosome screening

Intervention Type DIAGNOSTIC_TEST

Screening based on MALBAC-NGS technology

Interventions

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Noninvasive chromosome screening

Screening based on MALBAC-NGS technology

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

49 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Bernabeu

OTHER

Sponsor Role lead

Responsible Party

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Belen Lledo

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Belén Lledo, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Bernabeu

Locations

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Instituto Bernabeu

Alicante, , Spain

Site Status

Countries

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Spain

Other Identifiers

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IBB11

Identifier Type: -

Identifier Source: org_study_id

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