Noninvasive Preimplantation Genetic Testing for Aneuploidy
NCT ID: NCT04490889
Last Updated: 2020-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
218 participants
OBSERVATIONAL
2020-08-15
2020-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Patients with PGT indication
Patients undergo in vitro fertilization with PGT-A or for PGT-SR indication
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Having PGT-A or PGT-SR indication
* Having an agreement to be enrolled into NiPGT-A study
* Having blastocyst to biopsy
Exclusion Criteria
ALL
No
Sponsors
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My Duc Phu Nhuan Hospital
UNKNOWN
Mỹ Đức Hospital
OTHER
Responsible Party
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Principal Investigators
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Lan N Vuong
Role: PRINCIPAL_INVESTIGATOR
Mỹ Đức Hospital
Locations
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My Duc Phu Nhuan Hospital
Ho Chi Minh City, Phu Nhuan, Vietnam
My Duc Hospital
Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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Vinh Q Dang, MD
Role: primary
Other Identifiers
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CS/BVMĐ/20/11
Identifier Type: -
Identifier Source: org_study_id
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