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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive chromosome screening | Diagnostic Test | Screening based on MALBAC-NGS technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Mosaicism | Presence of mosaicism | At Day 5-6 after FIV |
| Quality value of NICS DLRS | Quality value of noninvasive chromosome screening (NICS) derivative Log Ratio Spread (DLRS) | At Day 5-6 after FIV |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Belén Lledo, PhD | Instituto Bernabeu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Bernabeu | Alicante | Spain |
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| ID | Term |
|---|---|
| D002869 | Chromosome Aberrations |
| D000013 | Congenital Abnormalities |
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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Embryo culture medium