Clinical Application of Non-invasive Preimplantation Genetic Testing for Aneuploidies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile women who undergo IVF with PGT
- •BMI:18~30 kg/m2
排除标准
- •Primary ovarian insufficiency
- •Congenital uterine anomaly
- •Severe male infertility (azoospermia)
- •One of the couples with chromosome abnormality
- •Malignancy
结局指标
主要结局
Ongoing pregnancy rate
时间窗: through study completion, an average of 1.5 year
continuous presence of a fetal heartbeat over 12 weeks of a pregnancy
次要结局
- Clinical pregnancy rate(through study completion, an average of 1.5 year)
- Miscarriage rate(through study completion, an average of 1.5 year)
研究者
Li-Te Lin
Attending doctor, Department of Obstetrics and Gynecology, Principal Investigator, Assistant professor
Kaohsiung Veterans General Hospital.