Clinical Application of Non-invasive PGT-A

Kaohsiung Veterans General Hospital

Status: Completed

Conditions: Genetic Testing

Treatments: Diagnostic Test: non-invasive PGT-A; Diagnostic Test: PGT-A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04856696

KSVGH20-CT12-16

Details and patient eligibility

About

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.

Full 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

Enrollment: 22 patients

Sex: Female

Ages: 30 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 3 patient groups

combined non-invasive PGT-A & PGT-A

Experimental group

Description:

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

Treatment:

Diagnostic Test: PGT-A

Diagnostic Test: non-invasive PGT-A

non-invasive PGT-A

Experimental group

Description:

Infertility women who underwent non-invasive PGT-A only

Treatment:

Diagnostic Test: non-invasive PGT-A

PGT-A

Active Comparator group

Description:

Infertility women who underwent PGT-A only

Treatment:

Diagnostic Test: PGT-A