AzTrials
AzTrials

Genetic TestingNCT04856696

Clinical Application of Non-invasive PGT-A

A study testing PGT-A and non-invasive PGT-A in people with Genetic Testing, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study aims to investigate the difference of in vitro fertilization (IVF) outcomes among non-invasive PGT-A, PGT-A and combined non-invasive PGT-A and PGT-A. Read more about this study

Who is it for?
Ages 30 to 44 years, women only
Conditions the study is for
Genetic Testing
What is being tested?
PGT-A and non-invasive PGT-A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteTaiwan
Study dates
24 Mar 2021to 31 Dec 2023
Phase
Interventional
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 30 to 44 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Infertile women who undergo IVF with PGT
  • BMI:18~30 kg/m2

Who cannot join

  • Primary ovarian insufficiency
  • Congenital uterine anomaly
  • Severe male infertility (azoospermia)
  • One of the couples with chromosome abnormality
  • Malignancy

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

Other trials in Taiwan

About this study

Official title: Clinical Application of Non-invasive Preimplantation Genetic Testing for Aneuploidies

The study aims to investigate the difference of in vitro fertilization (IVF) outcomes among non-invasive PGT-A, PGT-A and combined non-invasive PGT-A and PGT-A.

Read the detailed description

Background Chromosome abnormality is a leading cause of implantation failure and miscarriage. Chromosome abnormality increases with age, resulting in reduced pregnancy rate. Nowadays, preimplantation genetic testing for aneuploidies (PGT-A) could be used for detection of aneuploidy. However, PGT-A needs embryo biopsy which is invasive and may cause embryo damage. It was found that cell free DNA could be isolated from culture media. The cell free DNA from culture media also could be used to detect embryo ploidy, called non-invasive PGT-A.

Objective The study aims to investigate the difference of in vitro fertilization (IVF) outcomes among non-invasive PGT-A, PGT-A and combined non-invasive PGT-A and PGT-A. Another aim of this study is to check the concordance rate between non-invasive PGT-A and PGT-A.

Methods The prospective cohort study will be performed at the reproductive medical center of Kaohsiung Veterans General Hospital, in Kaohsiung, Taiwan. Participants who plan to receive an IVF cycle and preimplantation genetic testing for aneuploidies will be enrolled in this study. The investigators will divide the participants into 3 groups: (1) combined non-invasive PGT-A and PGT-A; (2) PGT-A; (3) non-invasive PGT-A. Basal characteristics, infertility history, ovarian reserve and embryo development of the three groups will be recorded. The samples will be detected ploidy by using next generation sequencing (NGS). Then, the investigators will choose embryo to transfer according to the embryo ploidy and follow the pregnancy outcomes after embryo transfer.

Outcome

  1. Concordance rate between non-invasive PGT-A and PGT-A
  2. The relationship between morphological grade and ploidy of non-invasive PGT-A
  3. IVF outcomes among non-invasive PGT-A, PGT-A and combined non-invasive PGT-A and PGT-A
Conditions
Genetic Testing
Being tested
PGT-A, non-invasive PGT-A
Keywords
PGT, PGT-A, non-invasive PGT-A, embryo biopsy, spent media, cell free DNA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PGT-ADiagnostic test

    trophectoderm biopsy in blastocyst stage for euploidy testing using next generation sequencing platform

  • non-invasive PGT-ADiagnostic test

    cell-free DNA collected from spent culture media for euploidy testing using next generation sequencing platform

Study groups in NCT04856696
Study groupRoleWhat they receive
combined non-invasive PGT-A & PGT-AExperimentalInfertility women who underwent both non-invasive PGT-A and PGT-A
Receives: Diagnostic Test: PGT-A; Diagnostic Test: non-invasive PGT-A
non-invasive PGT-AExperimentalInfertility women who underwent non-invasive PGT-A only
Receives: Diagnostic Test: non-invasive PGT-A
PGT-AActive comparatorInfertility women who underwent PGT-A only
Receives: Diagnostic Test: PGT-A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ongoing pregnancy rate

    continuous presence of a fetal heartbeat over 12 weeks of a pregnancy

    Measured: through study completion, an average of 1.5 year

Secondary outcomes (2)

  1. Clinical pregnancy rate

    the presence of a fetal heartbeat at 6-7 weeks of a pregnancy

    Measured: through study completion, an average of 1.5 year

  2. Miscarriage rate

    pregnancy loss before 24 weeks of gestation

    Measured: through study completion, an average of 1.5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2021
  2. Study start24 Mar 2021
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04856696
Sponsor's protocol ID
KSVGH20-CT12-16
Status last verified
Aug 2024
First submitted
19 Apr 2021
Last updated
2 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fesahat F, Montazeri F, Hoseini SM. Preimplantation genetic testing in assisted reproduction technology. J Gynecol Obstet Hum Reprod. 2020 May;49(5):101723. doi: 10.1016/j.jogoh.2020.101723. Epub 2020 Feb 26.

    PubMed 32113002

  • Sciorio R, Dattilo M. PGT-A preimplantation genetic testing for aneuploidies and embryo selection in routine ART cycles: Time to step back? Clin Genet. 2020 Aug;98(2):107-115. doi: 10.1111/cge.13732. Epub 2020 Apr 6.

    PubMed 32141057

  • Homer HA. Preimplantation genetic testing for aneuploidy (PGT-A): The biology, the technology and the clinical outcomes. Aust N Z J Obstet Gynaecol. 2019 Apr;59(2):317-324. doi: 10.1111/ajo.12960. Epub 2019 Feb 27.

    PubMed 30811595

  • Fragouli E, Munne S, Wells D. The cytogenetic constitution of human blastocysts: insights from comprehensive chromosome screening strategies. Hum Reprod Update. 2019 Jan 1;25(1):15-33. doi: 10.1093/humupd/dmy036.

    PubMed 30395265

  • Sullivan-Pyke C, Dokras A. Preimplantation Genetic Screening and Preimplantation Genetic Diagnosis. Obstet Gynecol Clin North Am. 2018 Mar;45(1):113-125. doi: 10.1016/j.ogc.2017.10.009.

    PubMed 29428279

  • Rubio C, Navarro-Sanchez L, Garcia-Pascual CM, Ocali O, Cimadomo D, Venier W, Barroso G, Kopcow L, Bahceci M, Kulmann MIR, Lopez L, De la Fuente E, Navarro R, Valbuena D, Sakkas D, Rienzi L, Simon C. Multicenter prospective study of concordance between embryonic cell-free DNA and trophectoderm biopsies from 1301 human blastocysts. Am J Obstet Gynecol. 2020 Nov;223(5):751.e1-751.e13. doi: 10.1016/j.ajog.2020.04.035. Epub 2020 May 26.

    PubMed 32470458

  • Rubio C, Rienzi L, Navarro-Sanchez L, Cimadomo D, Garcia-Pascual CM, Albricci L, Soscia D, Valbuena D, Capalbo A, Ubaldi F, Simon C. Embryonic cell-free DNA versus trophectoderm biopsy for aneuploidy testing: concordance rate and clinical implications. Fertil Steril. 2019 Sep;112(3):510-519. doi: 10.1016/j.fertnstert.2019.04.038. Epub 2019 Jun 11.

    PubMed 31200971

  • Leaver M, Wells D. Non-invasive preimplantation genetic testing (niPGT): the next revolution in reproductive genetics? Hum Reprod Update. 2020 Jan 1;26(1):16-42. doi: 10.1093/humupd/dmz033.

    PubMed 31774124

  • Kuznyetsov V, Madjunkova S, Abramov R, Antes R, Ibarrientos Z, Motamedi G, Zaman A, Kuznyetsova I, Librach CL. Minimally Invasive Cell-Free Human Embryo Aneuploidy Testing (miPGT-A) Utilizing Combined Spent Embryo Culture Medium and Blastocoel Fluid -Towards Development of a Clinical Assay. Sci Rep. 2020 Apr 29;10(1):7244. doi: 10.1038/s41598-020-64335-3.

    PubMed 32350403

  • Liang B, Gao Y, Xu J, Song Y, Xuan L, Shi T, Wang N, Hou Z, Zhao YL, Huang WE, Chen ZJ. Raman profiling of embryo culture medium to identify aneuploid and euploid embryos. Fertil Steril. 2019 Apr;111(4):753-762.e1. doi: 10.1016/j.fertnstert.2018.11.036. Epub 2019 Jan 22.

    PubMed 30683589

  • Jiao J, Shi B, Sagnelli M, Yang D, Yao Y, Li W, Shao L, Lu S, Li D, Wang X. Minimally invasive preimplantation genetic testing using blastocyst culture medium. Hum Reprod. 2019 Jul 8;34(7):1369-1379. doi: 10.1093/humrep/dez075.

    PubMed 31251795

  • Huang L, Bogale B, Tang Y, Lu S, Xie XS, Racowsky C. Noninvasive preimplantation genetic testing for aneuploidy in spent medium may be more reliable than trophectoderm biopsy. Proc Natl Acad Sci U S A. 2019 Jul 9;116(28):14105-14112. doi: 10.1073/pnas.1907472116. Epub 2019 Jun 24.

    PubMed 31235575

  • Fang R, Yang W, Zhao X, Xiong F, Guo C, Xiao J, Chen L, Song X, Wang H, Chen J, Xiao X, Yao B, Cai LY. Chromosome screening using culture medium of embryos fertilised in vitro: a pilot clinical study. J Transl Med. 2019 Mar 8;17(1):73. doi: 10.1186/s12967-019-1827-1.

    PubMed 30849973

  • Vera-Rodriguez M, Diez-Juan A, Jimenez-Almazan J, Martinez S, Navarro R, Peinado V, Mercader A, Meseguer M, Blesa D, Moreno I, Valbuena D, Rubio C, Simon C. Origin and composition of cell-free DNA in spent medium from human embryo culture during preimplantation development. Hum Reprod. 2018 Apr 1;33(4):745-756. doi: 10.1093/humrep/dey028.

    PubMed 29471395

  • Belandres D, Shamonki M, Arrach N. Current status of spent embryo media research for preimplantation genetic testing. J Assist Reprod Genet. 2019 May;36(5):819-826. doi: 10.1007/s10815-019-01437-6. Epub 2019 Mar 21.

    PubMed 30895497

Questions about this trial

What is this clinical trial studying?

A study testing PGT-A and non-invasive PGT-A in people with Genetic Testing, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

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 2 inclusion and 5 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: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ongoing pregnancy rate (time frame: through study completion, an average of 1.5 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04856696, which also lists 19 linked publications.

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 2 Aug 2024.

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