NCT04856696

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 2, 2024

Status Verified

August 1, 2024

Enrollment Period

2.8 years

First QC Date

April 19, 2021

Last Update Submit

August 1, 2024

Conditions

Genetic Testing

Keywords

PGTPGT-Anon-invasive PGT-Aembryo biopsyspent mediacell free DNA

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

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

    through study completion, an average of 1.5 year

Secondary Outcomes (2)

  • Clinical pregnancy rate

    through study completion, an average of 1.5 year

  • Miscarriage rate

    through study completion, an average of 1.5 year

Study Arms (3)

combined non-invasive PGT-A & PGT-A

EXPERIMENTAL

Infertility women who underwent both non-invasive PGT-A and PGT-A

Diagnostic Test: PGT-ADiagnostic Test: non-invasive PGT-A

non-invasive PGT-A

EXPERIMENTAL

Infertility women who underwent non-invasive PGT-A only

Diagnostic Test: non-invasive PGT-A

PGT-A

ACTIVE COMPARATOR

Infertility women who underwent PGT-A only

Diagnostic Test: PGT-A

Interventions

PGT-ADIAGNOSTIC_TEST

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

PGT-Acombined non-invasive PGT-A & PGT-A
non-invasive PGT-ADIAGNOSTIC_TEST

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

combined non-invasive PGT-A & PGT-Anon-invasive PGT-A

Eligibility Criteria

Age30 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Related Publications (19)

  • 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.

    PMID: 32113002BACKGROUND

  • 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.

    PMID: 32141057BACKGROUND

  • 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.

    PMID: 30811595BACKGROUND

  • 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.

    PMID: 30395265BACKGROUND

  • 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.

    PMID: 29428279BACKGROUND

  • 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.

    PMID: 32470458BACKGROUND

  • 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.

    PMID: 31200971BACKGROUND

  • 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.

    PMID: 31774124BACKGROUND

  • 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.

    PMID: 32350403BACKGROUND

  • 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.

    PMID: 30683589BACKGROUND

  • 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.

    PMID: 31251795BACKGROUND

  • 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.

    PMID: 31235575BACKGROUND

  • 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.

    PMID: 30849973BACKGROUND

  • 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.

    PMID: 29471395BACKGROUND

  • 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.

    PMID: 30895497BACKGROUND

  • Farra C, Choucair F, Awwad J. Non-invasive pre-implantation genetic testing of human embryos: an emerging concept. Hum Reprod. 2018 Dec 1;33(12):2162-2167. doi: 10.1093/humrep/dey314.

    PMID: 30357338BACKGROUND

  • Xu J, Fang R, Chen L, Chen D, Xiao JP, Yang W, Wang H, Song X, Ma T, Bo S, Shi C, Ren J, Huang L, Cai LY, Yao B, Xie XS, Lu S. Noninvasive chromosome screening of human embryos by genome sequencing of embryo culture medium for in vitro fertilization. Proc Natl Acad Sci U S A. 2016 Oct 18;113(42):11907-11912. doi: 10.1073/pnas.1613294113. Epub 2016 Sep 29.

    PMID: 27688762BACKGROUND

  • Shamonki MI, Jin H, Haimowitz Z, Liu L. Proof of concept: preimplantation genetic screening without embryo biopsy through analysis of cell-free DNA in spent embryo culture media. Fertil Steril. 2016 Nov;106(6):1312-1318. doi: 10.1016/j.fertnstert.2016.07.1112. Epub 2016 Aug 24.

    PMID: 27565258BACKGROUND

  • Youssef MM, Mantikou E, van Wely M, Van der Veen F, Al-Inany HG, Repping S, Mastenbroek S. Culture media for human pre-implantation embryos in assisted reproductive technology cycles. Cochrane Database Syst Rev. 2015 Nov 20;2015(11):CD007876. doi: 10.1002/14651858.CD007876.pub2.

    PMID: 26585317BACKGROUND

Study Officials

  • Kuan-Hao Tsui

    Kaohsiung Veterans General Hospital.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending doctor, Department of Obstetrics and Gynecology, Principal Investigator, Assistant professor

Study Record Dates

First Submitted

April 19, 2021

First Posted

April 23, 2021

Study Start

March 24, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 2, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)