Clinical Application of Non-invasive PGT-A

Not Applicable

Completed

• Conditions: Genetic Testing
• Interventions: Diagnostic Test: PGT-A; Diagnostic Test: non-invasive PGT-A

• Registration Number: NCT04856696
• Lead Sponsor: Kaohsiung Veterans General Hospital.

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.

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 Timeline

• Study Start: 2021-03-24
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-23
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combined non-invasive PGT-A & PGT-A	non-invasive PGT-A	Infertility women who underwent both non-invasive PGT-A and PGT-A
combined non-invasive PGT-A & PGT-A	PGT-A	Infertility women who underwent both non-invasive PGT-A and PGT-A
PGT-A	PGT-A	Infertility women who underwent PGT-A only
non-invasive PGT-A	non-invasive PGT-A	Infertility women who underwent non-invasive PGT-A only

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	through study completion, an average of 1.5 year	continuous presence of a fetal heartbeat over 12 weeks of a pregnancy

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	through study completion, an average of 1.5 year	the presence of a fetal heartbeat at 6-7 weeks of a pregnancy
Miscarriage rate	through study completion, an average of 1.5 year	pregnancy loss before 24 weeks of gestation

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan