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Trial record 4 of 4 for:    niPGT-A

Noninvasive Preimplantation Genetic Testing for Aneuploidy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
My Duc Phu Nhuan Hospital
Information provided by (Responsible Party):
Mỹ Đức Hospital

Tracking Information
First Submitted Date July 24, 2020
First Posted Date July 29, 2020
Last Update Posted Date September 22, 2020
Actual Study Start Date August 15, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 24, 2020)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 30, 2020)
  • 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
Original Secondary Outcome Measures
 (submitted: July 24, 2020)
  • Successful amplification [ Time Frame: 7 days after SCM collection ]
    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 test [ Time Frame: at 2 weeks after embryo transfer ]
    Serum human chorionic gonadotropin level greater than 25 mIU/mL
  • Clinical pregnancy [ Time Frame: 5 weeks after embryo transfer ]
    at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity.
  • Ongoing pregnancy [ Time Frame: At 12 weeks' gestation ]
    Ongoing pregnancy is defined as pregnancy with detectable heart rate 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Noninvasive Preimplantation Genetic Testing for Aneuploidy
Official Title Noninvasive Preimplantation Genetic Testing for Aneuploidy Using Cell Free DNA on Spent Culture Media
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
TE biopsy of blastocyst and cfDNA into spent culture media.
Sampling Method Probability Sample
Study Population Patients undergo in vitro fertilization.
Condition
  • Preimplantation Genetic Testing (PGT)
  • ICSI
Intervention 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.
Study Groups/Cohorts Patients with PGT indication
Patients undergo in vitro fertilization with PGT-A or for PGT-SR indication
Intervention: Diagnostic Test: NiPGT-A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 24, 2020)
218
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number NCT04490889
Other Study ID Numbers CS/BVMĐ/20/11
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Mỹ Đức Hospital
Original Responsible Party Same as current
Current Study Sponsor Mỹ Đức Hospital
Original Study Sponsor Same as current
Collaborators My Duc Phu Nhuan Hospital
Investigators
Principal Investigator: Lan N Vuong Mỹ Đức Hospital
PRS Account Mỹ Đức Hospital
Verification Date September 2020