An observational study in Chromosome Abnormality and Abnormality, sponsored by Instituto Bernabeu. Completed at 1 site in Spain. Open to male participants aged 19 Years to 49 Years. Per ClinicalTrials.gov, last updated 2020-08-10.
Sponsored by Instituto Bernabeu · Observational
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.
980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.
This study's enrollment of 50 is below the median of 153 across 446 observational studies indexed under Congenital Abnormalities.
Browse Congenital Abnormalities studies →Instituto Bernabeu is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
Presence of Mosaicism
Presence of mosaicism
Time frame: At Day 5-6 after FIV
Quality value of NICS DLRS
Quality value of noninvasive chromosome screening (NICS) derivative Log Ratio Spread (DLRS)
Time frame: At Day 5-6 after FIV
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Instituto Bernabeu