ICSI Clinical Trial
Official title:
Noninvasive Preimplantation Genetic Testing for Aneuploidy Using Cell Free DNA on Spent Culture Media
The study is conducted to evaluate the sensitivity and specificity of non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) using cell free DNA into spent culture medium (SCM).
Our study is a diagnostic study, recruit 218 biopsied blastocysts from couples undergoing
intracytoplasmic sperm injection (ICSI) with Preimplantation genetic testing for aneuploidy
(PGT-A) or Preimplantation genetic testing for structural rearrangements (PGT-SR) indication.
Oocyte retrieval, ICSI and embryo culture are performed by routine protocol.
On day 3, each embryo was washed and cultured in single droplets. TE biopsy was conducted and
10μl SCM of biopsied embryos are collected on day 5 or day 6. Both sample types undergo
whole-genome amplification (WGA) using Quanti Flour ONE dsDNA system and DNA analysis by
next-generation sequencing (NGS) using NextSeq High output 150 cycles kit.
Comparison of NGS results from trophectoderm (TE) biopsy and SCM is done to identify the
sensitivity and specificity of the test.
A sample size of 218 day 5/day 6 embryos will be needed.
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