NCT04490889

Noninvasive Preimplantation Genetic Testing for Aneuploidy

Noninvasive Preimplantation Genetic Testing for Aneuploidy Using Cell Free DNA on Spent Culture Media

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 218 (estimated)
• Sponsor: Mỹ Đức Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Preimplantation Genetic Testing (PGT)
• ICSI

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	NiPGT-A	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.

Timeline

• Start date: 2020-08-15
• Primary completion: 2020-10-31
• Completion: 2020-11-30
• First posted: 2020-07-29
• Last updated: 2020-09-22

Locations

2 sites across 1 country: Vietnam