Maternal Serum Cytokine Levels and Angiogenic Factor Levels in Singleton IVF Pregnancies vs Spontaneously Conceived Pregnancies
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- sFlt, human endoglin, PlGF, VEGF, IL-1, IL-2, IL-1ra, IL-4, IL-5, EGF, IL-6, Human IL-7, TGF, Fractalkine, IL-8, IL-10, IL-12p70, IL-13, IL-15, IL-17, IL-1, IFN-gamma, G-CSF, GM-CSF, TNF, Eotaxin, MCP-1, sCD40L, IL-12p40, MIP-1, MIP-1ß, IP-10
研究概览
简要总结
The objective of the study is to compare maternal levels of cytokines and angiogenic factors in IVF vs spontaneously conceived singleton pregnancies. The null hypothesis is that there will be no significant difference.
详细描述
IVF subjects: Subjects will be screened for participation at the Magella Office in Long Beach. Healthy patients with singleton pregnancies conceived with ART will be invited to participate.
Control subjects: A group of control subjects with spontaneously conceived, singleton pregnancies matched for age, parity, and race, will be identified at our Magella offices in Long Beach.
Sample size: 20 IVF subjects and 20 control subjects will be enrolled. A power analysis was performed using an alpha error of 0.05 and beta error of 0.80. Calculations were made for a 30% difference in the most studied markers during each trimester. The specific markers used in the power analysis were VEGF, sFlt, sEng, PlGF, IL-6, IL-8, TGF-beta1, and TNF-alpha. Using the values for the markers with the most stringent criteria it was determined that 15 patients would be required in each group to demonstrate a significant difference using a p value of 0.05. In anticipation of a 20-25% drop out rate, 20 subjects will be enrolled in each arm.
Specimens will be obtained at the specified intervals. Venipuncture will be performed and no more than 20 ml of blood will be obtained.
Within 2 hours of the blood draw, the blood will be spun at 2000 rpm for 10 minutes. The plasma layer will then be collected into 1 ml aliquots and stored frozen at -80°C. Upon completion of specimen collection, assays will be performed by personnel who are unaware of the outcome of the pregnancy. The markers being evaluated are not currently routinely used in clinical practice thus preventing a retrospective analysis.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy patients with singleton pregnancies conceived with ART and control subjects with spontaneously conceived pregnancies. Only subjects that are already pregnant and have confirmed singleton intrauterine pregnancies are eligible.
排除标准
- •Subjects with hypertension, diabetes, renal disease, illicit drug use, tobacco use, morbid obesity, collagen vascular disease, and autoimmune diseases will be excluded from participation.
- •Pregnancies that had more than one gestation viewed on ultrasound at any time will be excluded.
结局指标
主要结局
sFlt, human endoglin, PlGF, VEGF, IL-1, IL-2, IL-1ra, IL-4, IL-5, EGF, IL-6, Human IL-7, TGF, Fractalkine, IL-8, IL-10, IL-12p70, IL-13, IL-15, IL-17, IL-1, IFN-gamma, G-CSF, GM-CSF, TNF, Eotaxin, MCP-1, sCD40L, IL-12p40, MIP-1, MIP-1ß, IP-10
时间窗: 10 months
次要结局
未报告次要终点