Noninvasive Preimplantation Genetic Testing for Aneuploidy
1 other identifier
observational
218
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2020
CompletedFirst Posted
Study publicly available on registry
July 29, 2020
CompletedStudy Start
First participant enrolled
August 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedSeptember 22, 2020
September 1, 2020
3 months
July 24, 2020
September 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (6)
Successful amplification rate
7 days after SCM collection
Total concordance
14 days after SCM collection
Positive pregnancy rate
at 2 weeks after embryo transfer
Clinical pregnancy rate
5 weeks after embryo transfer
Ongoing pregnancy rate
At 12 weeks' gestation
- +1 more secondary outcomes
Study Arms (1)
Patients with PGT indication
Patients undergo in vitro fertilization with PGT-A or for PGT-SR indication
Interventions
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
Patients undergo in vitro fertilization.
You may qualify if:
- 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
You may not qualify if:
- In vitro maturation cycle
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mỹ Đức Hospitallead
- My Duc Phu Nhuan Hospitalcollaborator
Study Sites (2)
My Duc Phu Nhuan Hospital
Ho Chi Minh City, Phu Nhuan, Vietnam
My Duc Hospital
Ho Chi Minh City, Vietnam
Biospecimen
TE biopsy of blastocyst and cfDNA into spent culture media.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lan N Vuong
Mỹ Đức Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2020
First Posted
July 29, 2020
Study Start
August 15, 2020
Primary Completion
October 31, 2020
Study Completion
November 30, 2020
Last Updated
September 22, 2020
Record last verified: 2020-09