Noninvasive Preimplantation Genetic Testing for Aneuploidy

Mỹ Đức Hospital

Status: Unknown

Conditions: Preimplantation Genetic Testing (PGT); ICSI

Treatments: Diagnostic Test: NiPGT-A

Study type: Observational

Funder types: Other

Identifiers

NCT04490889

CS/BVMĐ/20/11

Details and patient eligibility

About

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).

Full 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.

Enrollment: 218 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

218 participants in 1 patient group

Patients with PGT indication

Description:

Patients undergo in vitro fertilization with PGT-A or for PGT-SR indication

Treatment:

Diagnostic Test: NiPGT-A