The Eshre Study Into The Evaluation of Oocyte Euploidy by Microarray Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 396
- 试验地点
- 8
- 主要终点
- To assess the prediction value of having no euploid oocytes in future ART cycles.
研究概览
简要总结
A pragmatic, multicentre, randomized double-blind controlled trial with an intention-to-treat analysis, of the use of preimplantation genetic screening (PGS) for aneuploidy by means of microarray comparative genomic hybridization (CGH) for the chromosomal analysis of the polar bodies (PB) of oocytes collected after ovarian stimulation for in vitro fertilization (IVF), and with the intention to assess the genetic competence of oocytes of advanced biological age, and the effect of this technique on reproductive outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 36 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •infertility as an indication for IVF or ICSI;
- •patients between their 36th and 41st birthdays (at time of signing ICF i.e. max 40years and 364days at the day of signing the informed consent);
- •BMI range 18 to 30 kgs per m2;
- •patients prepared to accept transfer of up to two embryos;
- •absence of any type of genetic abnormality in the patient's personal and family history;
- •normal karyotype (optional)
排除标准
- •treatment involving donor oocytes (donor sperm is allowed subject to local practice and regulations and provided karyotype of the sperm donor is available and normal);
- •menstrual irregularity (<24 and >35 days);
- •three or more previous failed IVF or ICSI cycles, with the present partner. (Definition of a failed cycle: 'absence of a clinical pregnancy relating to a treatment with embryo transfer resulting from oocyte retrieval for the current intended pregnancy and with the current partner; the transfers include transfers of fresh and frozen within this treatment; clinical pregnancy is defined as the presence of a gestational sac at the earliest ultrasound and includes early clinical miscarriage, late miscarriage and clinically confirmed extrauterine pregnancy, and excludes preclinical miscarriage (biochemical pregnancy); -
- •three or more clinical miscarriages;
- •poor response in any previous cycle;
- •low ovarian reserve (At least one of the following two features must be present: (1) a previous poor ovarian response (≤ 3 oocytes with a conventional stimulation 119 protocol); (2) an abnormal ovarian reserve test (i.e. AFC < 5 follicles or AMH < 0,5 ng/mL)* (adapted from Ferraretti et al., 2011);
- •cycles requiring surgical sperm recovery procedures;
- •total asthenozoospermia and/or globozoospermia.
- •any type of genetic abnormality or family history of genetic abnormality in subject or partner
研究组 & 干预措施
Polar Body Biopsy
PB biopsy (PBB) will be performed between 9 and 12 hours after ICSI using laser or the mechanical procedure. PB1 and PB2 will be removed simultaneously (both at the same time) and transferred to different tubes for the chromosomal analysis.
干预措施: Polar Body Biopsy (Other)
No Polar Body Biopsy
结局指标
主要结局
To assess the prediction value of having no euploid oocytes in future ART cycles.
时间窗: Up to 1 year after birth
This trial has two primary aims among women with advanced maternal age (1) to improve live birth rates and (2) to assess the prediction value of having no euploid oocytes in future ART cycles.
To improve live birth rates.
时间窗: up to 1 year after birth
This trial has two primary aims among women with advanced maternal age (1) to improve live birth rates and (2) to assess the prediction value of having no euploid oocytes in future ART cycles.
次要结局
未报告次要终点
研究者
Karen Sermon
Prof. dr.
European Society of Human Reproduction and Embryology