Noninvasive Preimplantation Genetic Testing for Aneuploidy
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|ClinicalTrials.gov Identifier: NCT04490889|
Recruitment Status : Unknown
Verified September 2020 by Mỹ Đức Hospital.
Recruitment status was: Recruiting
First Posted : July 29, 2020
Last Update Posted : September 22, 2020
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|Condition or disease||Intervention/treatment|
|Preimplantation Genetic Testing (PGT) ICSI||Diagnostic Test: NiPGT-A|
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.
|Study Type :||Observational|
|Estimated Enrollment :||218 participants|
|Official Title:||Noninvasive Preimplantation Genetic Testing for Aneuploidy Using Cell Free DNA on Spent Culture Media|
|Actual Study Start Date :||August 15, 2020|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||November 30, 2020|
Patients with PGT indication
Patients undergo in vitro fertilization with PGT-A or for PGT-SR indication
Diagnostic Test: 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.
- Sensitivity of NiPGT-A [ Time Frame: 4 months after recruiting ]The ability to detect euploid embryo
- Specificity of NiPGT-A [ Time Frame: 4 months after recruiting ]The ability to detect aneuploid embryo
- Successful amplification rate [ Time Frame: 7 days after SCM collection ]Rate of SCM samples with DNA concentration after WGA greater than or equal 1ng/μl
- Total concordance [ Time Frame: 14 days after SCM collection ]The match NGS results from TE biopsy and SCM for ploidy and sex
- Positive pregnancy rate [ Time Frame: at 2 weeks after embryo transfer ]Rate of participants with serum human chorionic gonadotropin level greater than 25 mIU/mL
- Clinical pregnancy rate [ Time Frame: 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.
- Ongoing pregnancy rate [ Time Frame: At 12 weeks' gestation ]Rate of participants with detectable heart at 12 weeks' gestation or beyond, after the completion of the first transfer
- Implantation rate [ Time Frame: 3 weeks after embryo transfer ]as the number of gestational sacs per number of embryos transferred
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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
- In vitro maturation cycle
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04490889
|Contact: Dang V Vinhemail@example.com|
|Contact: Linh T Dofirstname.lastname@example.org|
|My Duc Phu Nhuan Hospital||Recruiting|
|Ho Chi Minh City, Phu Nhuan, Vietnam|
|Contact: Khang N Vu, MD 0983813006 email@example.com|
|My Duc Hospital||Recruiting|
|Ho Chi Minh City, Vietnam|
|Contact: Vinh Q Dang, MD|
|Principal Investigator:||Lan N Vuong||Mỹ Đức Hospital|
|Responsible Party:||Mỹ Đức Hospital|
|Other Study ID Numbers:||
|First Posted:||July 29, 2020 Key Record Dates|
|Last Update Posted:||September 22, 2020|
|Last Verified:||September 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Cell free DNA (cfDNA)