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.
Study Type
OBSERVATIONAL
Enrollment
218
NiPGT-A is the technique to screen the aneuploidy status of an embryo without invasion technique, such as biopsy. We use SCM to isolate cfDNA, then amplify and analyse the aneuploidy of embryo secreting this material using NGS technique.
My Duc Phu Nhuan Hospital
Ho Chi Minh City, Phu Nhuan, Vietnam
RECRUITINGMy Duc Hospital
Ho Chi Minh City, Vietnam
RECRUITINGSensitivity of NiPGT-A
The ability to detect euploid embryo
Time frame: 4 months after recruiting
Specificity of NiPGT-A
The ability to detect aneuploid embryo
Time frame: 4 months after recruiting
Successful amplification rate
Rate of SCM samples with DNA concentration after WGA greater than or equal 1ng/μl
Time frame: 7 days after SCM collection
Total concordance
The match NGS results from TE biopsy and SCM for ploidy and sex
Time frame: 14 days after SCM collection
Positive pregnancy rate
Rate of participants with serum human chorionic gonadotropin level greater than 25 mIU/mL
Time frame: at 2 weeks after embryo transfer
Clinical pregnancy rate
Rate of participants with at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity.
Time frame: 5 weeks after embryo transfer
Ongoing pregnancy rate
Rate of participants with detectable heart at 12 weeks' gestation or beyond, after the completion of the first transfer
Time frame: At 12 weeks' gestation
Implantation rate
as the number of gestational sacs per number of embryos transferred
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Time frame: 3 weeks after embryo transfer