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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

Study Description
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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).

Condition or disease Intervention/treatment
Preimplantation Genetic Testing (PGT) ICSI Diagnostic Test: NiPGT-A

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 Design
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Study Type : Observational
Estimated Enrollment : 218 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity of NiPGT-A [ Time Frame: 4 months after recruiting ]
    The ability to detect euploid embryo

  2. Specificity of NiPGT-A [ Time Frame: 4 months after recruiting ]
    The ability to detect aneuploid embryo


Secondary Outcome Measures :
  1. 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

  2. Total concordance [ Time Frame: 14 days after SCM collection ]
    The match NGS results from TE biopsy and SCM for ploidy and sex

  3. 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

  4. 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.

  5. 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

  6. 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
TE biopsy of blastocyst and cfDNA into spent culture media.

Eligibility Criteria
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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
Study Population
Patients undergo in vitro fertilization.
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Dang V Vinh +840908225481 bsvinh.dq@myduchospital.vn
Contact: Linh T Do +840774410490 dtlinh@hyvonghospital.vn

Locations
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Vietnam
My Duc Phu Nhuan Hospital Recruiting
Ho Chi Minh City, Phu Nhuan, Vietnam
Contact: Khang N Vu, MD    0983813006    bskhang.vn@myduchospital.vn   
My Duc Hospital Recruiting
Ho Chi Minh City, Vietnam
Contact: Vinh Q Dang, MD         
Sponsors and Collaborators
Mỹ Đức Hospital
My Duc Phu Nhuan Hospital
Investigators
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Principal Investigator: Lan N Vuong Mỹ Đức Hospital
More Information
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Responsible Party: Mỹ Đức Hospital
ClinicalTrials.gov Identifier: NCT04490889    
Other Study ID Numbers: CS/BVMĐ/20/11
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mỹ Đức Hospital:
NiPGT-A
Cell free DNA (cfDNA)
SCM
Sensitivity
Additional relevant MeSH terms:
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Aneuploidy
Chromosome Aberrations
Pathologic Processes