Cumulus Cell Messenger Ribonucleic Acid (mRNA) Analysis as Oocyte Quality Marker in the Fertility Lab in a Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Clinical Pregnancy as observed by ultrasound
研究概览
简要总结
Performing an additional non invasive oocyte diagnostic test based on cumulus gene expression could improve the outcome of the ART cycle.
详细描述
Background:
Currently, embryo selection before embryo transfer is done on the basis of morphological characteristics only. The morphology based selection procedure has only a limited predictive value. The need of an additional oocyte/embryo evaluating method is therefore required. This method should preferentially be: non invasive, objective, and available early in development. Each oocyte is surrounded with cumulus cells, cells which are normally disposed of during the assisted reproductive technique (ART)-procedure. A diagnostic test based on the cumulus cells fits al of the required criteria. In the current study the use of an oocyte diagnostic test based on cumulus cell gene expression is evaluated.
Primary purpose:
Validate a non invasive diagnostic test, not curing the infertility condition but improving the ART-treatment and as such reducing the physical and psychological effect of the (eventually failed) ART procedure or the potential side effects of this procedure on the patients.
Quality assurance plan for Data check and Source Data Verification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •scheduled for intracytoplasmatic sperm injection (ICSI) and single embryo transfer on day 3
- •patients down regulated with gonadotropin-releasing hormone (GnRH) antagonist and stimulated with Highly Purified human Menopausal Gonadotropin (HP-hMG)
- •no more than 2 previous IVF or ICSI cycles with transfer prior to this one.
- •Body mass index (BMI) should be higher than 17 and lower than 32
- •patients should have regular menstrual cycles (between 24 and 35 days).
排除标准
- •are smokers (>10 cigarettes per day)
- •patients requesting Prenatal Genetic Diagnosis
- •patients having polycystic ovary syndrome (PCOS), or Severe Endometriosis (AFS Stage 3-4)
- •couples where the partner has an extremely low sperm count e.g.: extreme oligo-astheno-teratozoospermia (OAT), (<100.000/ml) or testicular sperm extraction (TESE)
- •results of eventual preceding cycles may not indicate a known genetic disease, or low ovarian response or an oocyte maturation defect.
研究组 & 干预措施
CC-Test diagnosis and Day 3 transfer
Patients undergo the standard ART treatment, as prescribed by the treating physician, with standard morphology based scoring of the embryos + the extra cumulus cell based diagnosis and transfer of the best embryo based on morphology and CC diagnosis on day 3 of embryo growth (cleavage stage embryo).
干预措施: CC-Test (Other)
D3 transfer control group
Patients undergo the standard ART treatment, as prescribed by the treating physician, with standard morphology based scoring of the embryos and transfer of the best embryo based on day 3 of embryo growth (cleavage stage embryo).
D5 transfer control group
Patients undergo the standard ART treatment, as prescribed by the treating physician, with standard morphology based scoring of the embryos and transfer of the best embryo based on day 5 of embryo growth (blastocyst stage embryo).
结局指标
主要结局
Clinical Pregnancy as observed by ultrasound
时间窗: 2 months after embryo transfer
this observation is routinely performed by the treating physician for every patient undergoing standard ART treatment and is thus available from the fertility center database
次要结局
- Cumulative Pregnancy(2 years after pick up)
- Live Birth by questionaire(et least 9 months after embryo transfer)
- positive beta-hCG Pregnancy as observed by serum analysis(12-17 days after transfer)