Preimplantation Genetic Testing (PGT)NCT04490889
Noninvasive Preimplantation Genetic Testing for Aneuploidy
An observational study of Preimplantation Genetic Testing (PGT) and ICSI, run by Mỹ Đức Hospital at 2 sites in Vietnam.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preimplantation Genetic Testing (PGT), ICSI
- What is being tested?
- NiPGT-A
- How many people
- 218 participants
- Where
- 2 sitesVietnam
- Study dates
- 15 Aug 2020to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergo in vitro fertilization.
Who may be able to join
- 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
Who cannot join
- In vitro maturation cycle
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites, 2 recruiting
- Recruiting
My Duc Phu Nhuan Hospital
Ho Chi Minh City, Phu Nhuan
Khang N Vu, MD, 0983813006, bskhang.vn@myduchospital.vn
- Recruiting
My Duc Hospital
Ho Chi Minh City
Vinh Q Dang, MD
About this study
Official title: Noninvasive Preimplantation Genetic Testing for Aneuploidy Using Cell Free DNA on Spent Culture Media
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).
Read the 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.
- Conditions
- Preimplantation Genetic Testing (PGT), ICSI
- Being tested
- NiPGT-A
- Keywords
- NiPGT-A, Cell free DNA (cfDNA), SCM, Sensitivity
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiPGT-ADiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Patients with PGT indication | Patients undergo in vitro fertilization with PGT-A or for PGT-SR indication Receives: Diagnostic Test: NiPGT-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of NiPGT-A
The ability to detect euploid embryo
Measured: 4 months after recruiting
Specificity of NiPGT-A
The ability to detect aneuploid embryo
Measured: 4 months after recruiting
Secondary outcomes (6)
Successful amplification rate
Rate of SCM samples with DNA concentration after WGA greater than or equal 1ng/μl
Measured: 7 days after SCM collection
Total concordance
The match NGS results from TE biopsy and SCM for ploidy and sex
Measured: 14 days after SCM collection
Positive pregnancy rate
Rate of participants with serum human chorionic gonadotropin level greater than 25 mIU/mL
Measured: at 2 weeks after embryo transfer
Clinical pregnancy rate
Rate of participants with at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity.
Measured: 5 weeks after embryo transfer
Ongoing pregnancy rate
Rate of participants with detectable heart at 12 weeks' gestation or beyond, after the completion of the first transfer
Measured: At 12 weeks' gestation
Implantation rate
as the number of gestational sacs per number of embryos transferred
Measured: 3 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start15 Aug 2020
- Primary completion31 Oct 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preimplantation Genetic Testing (PGT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- My Duc Phu Nhuan Hospital
- Responsible party
- Sponsor
- Investigators
- Lan N Vuong, Principal investigator, Mỹ Đức Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490889
- Sponsor's protocol ID
- CS/BVMĐ/20/11
- Status last verified
- Sep 2020
- First submitted
- 24 Jul 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Preimplantation Genetic Testing for Aneuploidy Using Cell Free DNA on Spent Culture Media
- ClinicalTrials.gov ID
- NCT04490889
- Acronym / sponsor ID
- CS/BVMĐ/20/11
- Conditions
- Preimplantation Genetic Testing (PGT), ICSI
- Keywords
- NiPGT-A, Cell free DNA (cfDNA), SCM, Sensitivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Collaborators
- My Duc Phu Nhuan Hospital
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PGT indication | – | Diagnostic Test: NiPGT-APatients undergo in vitro fertilization with PGT-A or for PGT-SR indication |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergo in vitro fertilization.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- In vitro maturation cycle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiPGT-ANiPGT-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. | Diagnostic test | Patients with PGT indication |
Primary outcome
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
6 secondary outcomes
Successful amplification rate
Time frame: 7 days after SCM collection
Total concordance
Time frame: 14 days after SCM collection
Positive pregnancy rate
Time frame: at 2 weeks after embryo transfer
Clinical pregnancy rate
Time frame: 5 weeks after embryo transfer
Ongoing pregnancy rate
Time frame: At 12 weeks' gestation
Implantation rate
Time frame: 3 weeks after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
Related trials for Preimplantation Genetic Testing (PGT)
Enrolling by invitationObservational study
Effects of Trophectoderm (TE) Biopsy on the Health and Development of Children Born After Preimplantation Genetic Testing (PGT) Cycles.
Preimplantation Genetic Testing (PGT), Frozen Embryo Transfer Cycle
Not yet recruitingObservational study
Prospective International Multi-center Clinical Trial of PGT-A Upgrade
Infertility Assisted Reproductive Technology
Active, not recruitingObservational study
Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Couples With Non-obstructive Azoospermia (NOA)
Non-obstructive Azoospermia, Male Infertility
Not yet recruitingPhase 3
Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT-A
Preimplantation Genetic Testing, Progestin-primed Ovarian Stimulation
Enrolling by invitationObservational study
Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing
Infertility, Female, Infertility, Male
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lan N Vuong principal investigator
Mỹ Đức Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preimplantation Genetic Testing (PGT) and ICSI, run by Mỹ Đức Hospital at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dang V Vinh (+840908225481, bsvinh.dq@myduchospital.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of NiPGT-A (time frame: 4 months after recruiting). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.