PC Protocol: Preconceptional Screening Part 2
试验速览
- 阶段
- 不适用
- 发起方
- UMC Utrecht
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Ovarian response
研究概览
简要总结
Background: Despite considerable progress in the field of assisted reproductive technology (ART) maximum pregnancy rates generally do not exceed 30%. Furthermore, substantial differences in pregnancy rates are seen between women starting ART from seemingly similar clinical starting points and information on pregnancy/neonatal complications after ART is limited. For physicians and patients it would be extremely valuable if tools could be developed through which individualised chances of live birth and the development of pregnancy/neonatal complications can be calculated. In addition, there is increasing knowledge about health risks associated with subfertility and in particular with polycystic ovarian syndrome (PCOS) and premature ovarian failure (POF). An important void in research to date is the absence of a control group to check important new findings.
Objectives: The study protocol aims to form a cohort of normo-ovulatory women with a regular indication for ART which can aid the investigators principle lines of research:
- To study initial predictors of ovarian response to stimulation for IVF
- To study predictors of chances for live birth after repeated IVF cycles
- To assess the role for vascular health in the probabilities of success in ART treatment
- To study predictors for pregnancy and neonatal complications
- To form a control group for cycle disturbance studies
Study design: In this part of the protocol, serum and material for DNA analysis will be collected by asking patients to have 20 ml of blood drawn during a routine blood withdrawal. This blood will be stored in the Biobank of the UMC Utrecht at -80 C.
Study population: All women starting ART will be asked to participate. Women starting donorinsemination treatment will be asked to participate, from the viewpoint that they potentially will form a normal fertile control group.
Nature and extent of the burden and benefits associated with participation: There are no benefits or risks for the study patient as blood is withdrawn during a routine venapuncture and results will not be used for clinical practice.
详细描述
The aim of this protocol is to collect serum and genotype from normo-ovulatory women with a regular indication for IVF/ICSI that can aid further research into the investigators principle lines of research which include improving performance ART treatment , limiting pregnancy complications, and improving offspring health.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •normo-ovulatory with a regular indication for ART or undergoing donorinsemination
排除标准
- •Women with cycle disturbances
结局指标
主要结局
Ovarian response
时间窗: 3 years
number of oocytes, number of cycle cancellations, poor response, hyper response
次要结局
- Prediction of pregnancy(3 years)
- Adverse pregnancy outcome(3 years)
