Genetic Testing
Conditions
Keywords
PGT, PGT-A, non-invasive PGT-A, embryo biopsy, spent media, cell free DNA
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
Interventions
DIAGNOSTIC_TESTPGT-A
trophectoderm biopsy in blastocyst stage for euploidy testing using next generation sequencing platform
DIAGNOSTIC_TESTnon-invasive PGT-A
cell-free DNA collected from spent culture media for euploidy testing using next generation sequencing platform
Sponsors
Sofiva Genomics Co., Ltd.
Kaohsiung Veterans General Hospital.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 44 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Taiwan
Outcome results
None listed