A Randomized Double Blind Controlled Trial of Non-invasive Preimplantation Genetic Testing for Aneuploidy and Morphology Compared with Morphology Alone in in Vitro Fertilisation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 517
- 试验地点
- 1
- 主要终点
- Live birth
研究概览
简要总结
This study is to compare the efficacy in embryo selection based on morphology alone compared to morphology and non-invasive preimplantation genetic testing for aneuploidy (NIPGT-A) in infertile women undergoing in vitro fertilization (IVF). We supposed the embryo selection based on morphology and NIPGT-A results in a higher live birth rate and a lower miscarriage rate in IVF as compared with that based on morphology alone. Therefore we would like to conduct a double-blind randomized controlled trial.
Infertile women undergoing IVF will be enrolled. The spent culture medium (SCM) of each blastocyst will be frozen individually. They will be randomized into two groups: (1) the intervention group based on morphology and NIPGT-A and (2) the control group based on morphology alone. In the control group, blastocysts with the best quality morphology will be replaced first. In the intervention group, blastocysts with the best morphology and euploid result of SCM will be replaced first.The primary outcome is a live birth per the first embryo transfer. We would like to compare live birth rates and miscarriage rates between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged less than 43 years at the time of ovarian stimulation
- •At least two blastocysts suitable for freezing on day 5 or 6 after oocyte retrieval
排除标准
- •Less than two blastocysts suitable for freezing on day 5 or 6 after oocyte retrieval;
- •Women undergoing PGT for monogenic diseases or structural rearrangement of chromosomes;
- •Use of donor oocytes;
- •Hydrosalpinx shown on pelvic scanning and not surgically treated
结局指标
主要结局
Live birth
时间窗: Number of live births beyond 22 weeks of gestation
Birth beyond 22 weeks of gestation per the first FET
次要结局
- Apgar score(1 year)
- Ongoing pregnancy(10 weeks)
- Miscarriage defined(Pregnancy loss up to 22 weeks)
- Time to pregnancy(1 year)
- Cumulative live birth rate(Number of pregnancies leading to live birth within 6 months of randomization)
- Positive urine pregnancy test(Positive urine pregnancy test 14 days after embryo transfer)
- Clinical pregnancy(6 weeks)
- Ectopic pregnancy(12 weeks)
- Birth weight(1 year)
- Multiple pregnancy(more than one intrauterine sac at 6 weeks)
研究者
Professor Ernest Hung-Yu Ng
Professor
The University of Hong Kong