ICSI, Preimplantation Genetic Testing (PGT)
Conditions
Keywords
NiPGT-A, Cell free DNA (cfDNA), SCM, Sensitivity
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.
Interventions
DIAGNOSTIC_TESTNiPGT-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.
Sponsors
My Duc Phu Nhuan Hospital
Mỹ Đức Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of NiPGT-A | 4 months after recruiting | The ability to detect euploid embryo |
| Specificity of NiPGT-A | 4 months after recruiting | The ability to detect aneuploid embryo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive pregnancy rate | at 2 weeks after embryo transfer | Rate of participants with serum human chorionic gonadotropin level greater than 25 mIU/mL |
| Clinical pregnancy rate | 5 weeks after embryo transfer | Rate of participants with at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity. |
| Successful amplification rate | 7 days after SCM collection | Rate of SCM samples with DNA concentration after WGA greater than or equal 1ng/μl |
| Implantation rate | 3 weeks after embryo transfer | as the number of gestational sacs per number of embryos transferred |
| Ongoing pregnancy rate | At 12 weeks' gestation | Rate of participants with detectable heart at 12 weeks' gestation or beyond, after the completion of the first transfer |
| Total concordance | 14 days after SCM collection | The match NGS results from TE biopsy and SCM for ploidy and sex |
Countries
Vietnam
Contacts
Primary ContactDang V Vinh
Backup ContactLinh T Do
Outcome results
None listed