Does the Telomere Length in First Human Polar Body Correlates With the Telomere Length in Cumulus Cells: A Clinical Validation Study
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- telomere length (TL) of the first Polar body (PB) and TL in Cumulus cells (CC)
研究概览
简要总结
To investigate whether telomere length (TL) of the first Polar body (PB) correlates with TL in Cumulus cells (CC)
详细描述
With the present study we want to analyze, as a primary objective, whether telomere length (TL) in the first Polar Body (PB) correlates with TL in the corresponding Cumulus cells (CC). As a secondary objective, a possible correlation between TL in PBs and blastocyst TL and ploidy will be evaluated.
To our best knowledge, there are no studies evaluating TL in CC and TL in PBs of the corresponding oocyte. With the present prospective study, we sought to investigate whether there is a correlation between CC-TL and PB-TL. If a correlation exists, CC-TL assessment would serve as a valuable non-invasive technique to gain information about oocyte competence.
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
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI 18- 30kg/m2
- •Expected normo/high responders
- •Normal female/male karyotype
- •Antagonist protocol with agonist trigger.
- •PGT-A: NGS in blastocysts
- •Fresh autologous ejaculates (≥5 mill/ml)
- •Primary and secondary infertility
- •Only ICSI as insemination technique
排除标准
- •PCOS patients according to International evidence-based guideline for the assessment and management of polycystic ovarian syndrome 2018.
研究组 & 干预措施
MII with PB biopsy
Five selected MII will undergo sequential polar biopsy; on day 0 [PB1] (36-42 hours post trigger injection) and if fertilization occurred on day 1 [PB2] (17-20 hours post ICSI). On day 5, 6 or 7, the resulting blastocyst will be biopsied.
干预措施: First polar body biopsy in MII oocytes (Genetic)
MII with PB biopsy
Five selected MII will undergo sequential polar biopsy; on day 0 [PB1] (36-42 hours post trigger injection) and if fertilization occurred on day 1 [PB2] (17-20 hours post ICSI). On day 5, 6 or 7, the resulting blastocyst will be biopsied.
干预措施: PGT-A blastocyst (Genetic)
MII with no PB biopsy
MII will not go under polar body biopsy. On day 5, 6 or 7, the resulting blastocyst will be biopsied.
干预措施: PGT-A blastocyst (Genetic)
结局指标
主要结局
telomere length (TL) of the first Polar body (PB) and TL in Cumulus cells (CC)
时间窗: 8 weeks
Correlation between telomere length (TL) of the first Polar body (PB) and TL in Cumulus cells (CC)
次要结局
- To evaluate a possible correlation between TL-CC and ploidy TE(8 weeks)
- To correlate TL between both polar bodies(8 weeks)
- To evaluate telomerase activity (TA) in CC and a possible correlation with CC-TL(8 weeks)
- To evaluate FSH/LH gene expression in CC(8 weeks)
- To evaluate a possible correlation between ploidy in PBs and ploidy in TE biopsy(8 weeks)
- To evaluate TL in sperm + TL-PB and TL in TE(8 weeks)
- To correlate TL in male WBC and TL in sperm(8 weeks)
- To correlate TL in female WBC and TL in CC(8 weeks)
- To evaluate a possible correlation between TL-CC and TL-TE(8 weeks)
- PB biopsy and embryo development(8 weeks)
研究者
Ana Arnanz
Principal Investigator
ART Fertility Clinics LLC