Clinical Application of Non-invasive PGT-A

March 8, 2022 updated by: Li-Te Lin, Kaohsiung Veterans General Hospital.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 81362
        • Recruiting
        • Kaohsiung Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Li-Te Lin, PhD
        • Sub-Investigator:
          • Salvatore Giovanni Vitale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: combined non-invasive PGT-A & PGT-A
Infertility women who underwent both non-invasive PGT-A and PGT-A
Diagnostic test: PGT-A
trophectoderm biopsy in blastocyst stage for euploidy testing using next generation sequencing platform
Diagnostic test: non-invasive PGT-A
cell-free DNA collected from spent culture media for euploidy testing using next generation sequencing platform
Experimental: non-invasive PGT-A
Infertility women who underwent non-invasive PGT-A only
Diagnostic test: non-invasive PGT-A
cell-free DNA collected from spent culture media for euploidy testing using next generation sequencing platform
Active Comparator: PGT-A
Infertility women who underwent PGT-A only
Diagnostic test: PGT-A
trophectoderm biopsy in blastocyst stage for euploidy testing using next generation sequencing platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1.5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1.5 year
Miscarriage rate
Time Frame: through study completion, an average of 1.5 year
pregnancy loss before 24 weeks of gestation
through study completion, an average of 1.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Collaborators

Sofiva Genomics Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KSVGH20-CT12-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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