Noninvasive Preimplantation Genetic Testing for Aneuploidy Using Cell Free DNA on Spent Culture Media
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Preimplantation Genetic Testing (PGT)
- Sponsor
- Mỹ Đức Hospital
- Enrollment
- 218
- Locations
- 2
- Primary Endpoint
- Sensitivity of NiPGT-A
- Last Updated
- 5 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Assisted Reproductive Treatment with ICSI indication
- •Having PGT-A or PGT-SR indication
- •Having an agreement to be enrolled into NiPGT-A study
- •Having blastocyst to biopsy
Exclusion Criteria
- •In vitro maturation cycle
Outcomes
Primary Outcomes
Sensitivity of NiPGT-A
Time Frame: 4 months after recruiting
The ability to detect euploid embryo
Specificity of NiPGT-A
Time Frame: 4 months after recruiting
The ability to detect aneuploid embryo
Secondary Outcomes
- Total concordance(14 days after SCM collection)
- Ongoing pregnancy rate(At 12 weeks' gestation)
- Successful amplification rate(7 days after SCM collection)
- Positive pregnancy rate(at 2 weeks after embryo transfer)
- Clinical pregnancy rate(5 weeks after embryo transfer)
- Implantation rate(3 weeks after embryo transfer)