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Clinical Application of Non-invasive PGT-A

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ClinicalTrials.gov Identifier: NCT04856696
Recruitment Status : Unknown
Verified March 2022 by Li-Te Lin, Kaohsiung Veterans General Hospital..
Recruitment status was:  Recruiting
First Posted : April 23, 2021
Last Update Posted : March 9, 2022
Sponsor:
Collaborator:
Sofiva Genomics Co., Ltd.
Information provided by (Responsible Party):
Li-Te Lin, Kaohsiung Veterans General Hospital.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Genetic Testing Diagnostic Test: PGT-A Diagnostic Test: non-invasive PGT-A Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Clinical Application of Non-invasive Preimplantation Genetic Testing for Aneuploidies
Actual Study Start Date : March 24, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04856696


Contacts
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Contact: Li-Te Lin +88673464027 litelin1982@gmail.com

Locations
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Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 81362
Contact: Kuan-Hao Tsui, PhD    +886-7-3422121 ext 4014    khtsui60@gmail.com   
Principal Investigator: Li-Te Lin, PhD         
Sub-Investigator: Salvatore Giovanni Vitale         
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Sofiva Genomics Co., Ltd.
Investigators
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Study Director: Kuan-Hao Tsui Kaohsiung Veterans General Hospital.
More Information
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Publications:

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Responsible Party: Li-Te Lin, Attending doctor, Department of Obstetrics and Gynecology, Principal Investigator, Assistant professor, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT04856696    
Other Study ID Numbers: KSVGH20-CT12-16
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Li-Te Lin, Kaohsiung Veterans General Hospital.:
PGT
PGT-A
non-invasive PGT-A
 embryo biopsy
spent media
cell free DNA