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| Name | Class |
|---|---|
| My Duc Phu Nhuan Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with PGT indication | Patients undergo in vitro fertilization with PGT-A or for PGT-SR indication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NiPGT-A | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of NiPGT-A | The ability to detect euploid embryo | 4 months after recruiting |
| Specificity of NiPGT-A | The ability to detect aneuploid embryo | 4 months after recruiting |
| Measure | Description | Time Frame |
|---|---|---|
| Successful amplification rate | Rate of SCM samples with DNA concentration after WGA greater than or equal 1ng/μl | 7 days after SCM collection |
| Total concordance | The match NGS results from TE biopsy and SCM for ploidy and sex |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergo in vitro fertilization.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dang V Vinh | Contact | +840908225481 | bsvinh.dq@myduchospital.vn | |
| Linh T Do | Contact | +840774410490 | dtlinh@hyvonghospital.vn |
| Name | Affiliation | Role |
|---|---|---|
| Lan N Vuong | Mỹ Đức Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| My Duc Phu Nhuan Hospital | Recruiting | Ho Chi Minh City | Phu Nhuan | Vietnam |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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TE biopsy of blastocyst and cfDNA into spent culture media.
| 14 days after SCM collection |
| Positive pregnancy rate | Rate of participants with serum human chorionic gonadotropin level greater than 25 mIU/mL | 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. | 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 | At 12 weeks' gestation |
| Implantation rate | as the number of gestational sacs per number of embryos transferred | 3 weeks after embryo transfer |
| My Duc Hospital | Recruiting | Ho Chi Minh City | Vietnam |
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