Prospective Randomised Control Trial of Blastocyst Euploidy Assessment and Conditioned Embryo Transfer for Infertility Patients of Advanced Maternal Age
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Ongoing pregnancy
研究概览
简要总结
The study is designed to evaluate the effectiveness of pre-implantation genetic screening (PGS) for infertility patients of advanced maternal age undergoing assisted reproductive treatment. Half of the patients will have their embryos tested by PGS and 1 or 2 chromosomally normal embryos with the highest morphological grading transplanted back to the uterus. The other half of the participants will not have their embryos tested and 1 or 2 untested embryos with the highest morphological grading transplanted back to the uterus.
详细描述
PGS is an assisted reproductive technology that screens patients embryos, discriminating between embryos with a normal set of chromosomes (euploid) and those with an abnormal set of chromosomes (aneuploid). In this study, we will apply a novel validated next generation sequencing technology called copy number variation sequencing (CNV-Seq) to comprehensively screen a trophectoderm biopsy sample from patient's embryos for chromosomal abnormalities that commonly arise in human embryos. The hypothesis is that PGS performed using CNV-Seq on embryos produced by patients with a poor prognosis for pregnancy (maternal age > 35), followed by transfer of chromosomally normal euploid embryos, will result in significantly higher implantation, pregnancy and live birth rates and lower miscarriage rates compared to patients having no PGS.
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
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing in vitro fertilization (IVF)
- •Normal uterine function by ultrasound and absence of hysteromyoma
- •Regular menstrual cycle of 25-35 days
- •Normal hormone levels (WHO standard) for LH, PRL, E2, PROG, TEST and TSH
- •FSH 1-12 IU/L and follicle number > 5 on day 2-3 of menstrual cycle
- •Minimum of 3 blastocysts on day 5 of embryo development
- •Signed consent form
排除标准
- •Known endometriosis
- •Abnormal vaginal bleeding with no known cause
- •Known genital organ system malformation, unsuitable to conceive
- •Known currently active pelvic inflammation
- •Abnormal liver, kidney lab results, with clinical implications.
- •Known endocrine or metabolic disorders (pituitary gland, adrenal glands, pancreas, liver or kidney）
- •Known ovarian, breast, uterine, adrenal glands, pituitary gland or hypothalamus tumor
- •Known abnormal cervical cancer lesions, with clinical implications, within one year before PGS
- •History of chemo- or radio-therapy
- •Seropositive for HIV, Hep B, Hep C or TPPA/RPR (Syphilis)
- •Known ovarian poor response in previous cycles, i.e. after administration of GnRH for > 20 days
- •More than 2 implantation failures
- •More than 2 miscarriages
- •Known altered parental karyotype such as Robertsonian or reciprocal translocation
- •Use of sperm or oocyte donors
- •Severe male factor (surgical retrieval of sperm)
- •Preimplantation genetic diagnosis cycles for single gene diseases or sex selection
- •Participation in other IVF research studies
- •Patient refusal or inability to follow the protocol for any good reason, including clinical visit or lab test
结局指标
主要结局
Ongoing pregnancy
时间窗: Gestational week 20
次要结局
- Genetic health of the fetus(Gestational week 18)
研究者
Dr Li Wang
PGS trial co-ordinator
Chinese PLA General Hospital