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Completed

NCT Number: NCT04856696

Clinical Application of Non-invasive PGT-A

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.

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Key information

Conditions

Genetic Testing

Age range

30 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

About this study

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

  • Concordance rate between non-invasive PGT-A and PGT-A
  • The relationship between morphological grade and ploidy of non-invasive PGT-A
  • IVF outcomes among non-invasive PGT-A, PGT-A and combined non-invasive PGT-A and PGT-A

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

PGT-A

Diagnostic Test

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

non-invasive PGT-A

Diagnostic Test

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

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: through study completion, an average of 1.5 year

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

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: through study completion, an average of 1.5 year

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

  2. Miscarriage rate

    Time frame: through study completion, an average of 1.5 year

    pregnancy loss before 24 weeks of gestation

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Collaborators

  • Sofiva Genomics Co., Ltd.

Registry information

Official study title

Clinical Application of Non-invasive Preimplantation Genetic Testing for Aneuploidies

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 23, 2021
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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