Cumulus Cell mRNA Analysis as Oocyte Quality Marker in the Fertility Lab in a Prospective Single-center Study for rFSH Stimulated Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 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 cell gene expression could improve the outcome of the ART cycle for rFSH stimulated patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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 (or double) embryo transfer on day 3
- •patients down regulated with gonadotropin-releasing hormone (GnRH) antagonist and stimulated with recombinant Follicle Stimulating Hormone (FSH)
- •undergoing first or second IVF or ICSI cycle with transfer
- •Body Mass Index (BMI) between 17 and 33
- •regular menstrual cycle (between 24 and 35 days)
排除标准
- •smokers (> 10 cigarettes per day)
- •patients requesting Pre-implantation Genetic Diagnosis (PGD)
- •patients with polycystic ovary syndrome (PCOS), or severe endometriosis (AFS stage 3-4)
- •couples where the partner has an extremely low sperm count i.e.: extreme oligo-astheno-teratozoospermia (OAT) (< 100.000/ml) or scheduled for 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 described 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 (Diagnostic Test)
Day 3 transfer control group
Patients undergo the standard ART treatment, as described by the treating physician, with standard morphology based scoring of the embryos and transfer of the best embryo based on morphology on day 3 of embryo growth (cleavage stage embryo)
Day 5 transfer control group
Patients undergo the standard ART treatment, as described by the treating physician, with standard morphology based scoring of the embryos and transfer of the best embryo based on morphology 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
- Positive beta-hCG pregnancy as observed by serum analysis(12-17 days after embryo transfer)
- Live birth by questionnaire(at least 9 months after embryo transfer)
- Cumulative pregnancy by ultrasound (for pregnancy follow-up) and questionnaire (for live birth follow-up) (see outcome 1 and 3)(2 years after embryo transfer)