Co-incubation of Oocytes With Sperm: Defining the Optimal Incubation Time
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Normal fertilization rate
研究概览
简要总结
The current pilot study aims to evaluate the fertilization rates between sibling oocytes subjected to short incubation (2h) versus overnight incubation (16-20h). As secondary objectives, the abnormal fertilization, embryo development, blastocyst biopsy and euploid rates will be analyzed.
详细描述
All patients for whom at least 6 cumulus oocytes complexes (COCs) are assigned to IVF, with normal sperm parameters, are eligible for the study. An electronically generated randomization list will allocate the first half of the oocytes to one arm and the other half of the oocytes to the second arm. In case an odd number of oocytes will be inseminated, one extra oocyte will be allocated to the first arm. In this prospective observational pilot study, the fertilization potential of 40 patients will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Sperm parameters
- •Sperm concentration before capacitation: >15 million per ml (WHO) Total motility (PR+NP %): >40 (WHO) Progressive motility (PR %):>32 (WHO)
- •Sperm concentration after capacitation: >0.6 million per ml (not WHO defined) Progressive motility (PR %):>65 (WHO)
- •≥6 COCs assigned to IVF
- •BMI ≤35 kg/m2
- •Female age 18 to ≤ 43 years
- •All ovarian stimulation protocols
- •Fresh ejaculates
- •Abstinence duration 2-5 days
- •Presence or absence of sperm morphology data: as we do not have a diagnostic sperm analysis for all patients, the presence or absence of >4% normal morphology (WHO) will not be taken into account, even with known low (<4%) normal morphology
- •Couples requesting Preimplantation Genetic Testing for Aneuploidies
- •Arab population
排除标准
- •If the volume to be added after IVF is insufficient to perform IVF on all needed oocytes
- •Presence of >1 million per ml round cells in the ejaculate
- •If a couple's previous cycle was included in the study
- •Previous history of fertilization failure or <50% fertilisation
- •Globozoospermia
- •PCO according to the Rotterdam criteria
- •Progesterone >1.5 ng/ml on the day of trigger
研究组 & 干预措施
IVF: 2h exposure
Half of a patients' oocytes will be subjected to 2h exposure to sperm
干预措施: 2h exposure to sperm for IVF (Other)
IVF: overnight exposure
Half of a patients' oocytes will be subjected to overnight incubation with sperm (=usual practice).
干预措施: overnight exposure to sperm for IVF (Other)
结局指标
主要结局
Normal fertilization rate
时间窗: 2 days
presence of two pronuclei per inseminated oocyte
次要结局
- Number of COCs assigned to each group(2 days)
- blastulation rate II(8 days)
- Implantation rate(80 days)
- Day of trophectoderm biopsy(8 days)
- Maturation rate(2 days)
- Total fertilization failure(3 days)
- blastulation rate I(8 days)
- Euploid rate(8 days)
- Clinical pregnancy Fetal Heart beat positive(80 days)
- Fertilization(3 days)
- Embryo quality on day 3(5 days)
- Utilization rate(8 days)
- Morphokinetic parameters(10 days)
- Embryo quality on day 5(8 days)
- Pregnancy outcome(60 days)
- Biochemical pregnancy(70 days)