Validation of a NICS Method Using the Culture Medium

Instituto Bernabeu

Status: Completed

Conditions: Chromosome Abnormality; Abnormality

Treatments: Diagnostic Test: Noninvasive chromosome screening

Study type: Observational

Funder types: Other

Identifiers

NCT03879265

IBB11

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Male

Ages: 19 to 49 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Study group

Description:

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).

Treatment:

Diagnostic Test: Noninvasive chromosome screening