Clinical Application of Non-invasive PGT-A

Study Overview
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Brief Summary
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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
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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

Official Title
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Clinical Application of Non-invasive Preimplantation Genetic Testing for Aneuploidies

Conditions
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Genetic Testing

Intervention / Treatment
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* Diagnostic Test: PGT-A
* Diagnostic Test: non-invasive PGT-A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | 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 | the presence of a fetal heartbeat at 6-7 weeks of a pregnancy | through study completion, an average of 1.5 year | 
| Miscarriage rate | pregnancy loss before 24 weeks of gestation | through study completion, an average of 1.5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PGT, PGT-A, non-invasive PGT-A, embryo biopsy, spent media, cell free DNA