A Lifestyle Intervention to Improve in Vitro Fertilization Results
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- The rate of viable pregnancies
研究概览
简要总结
Embryo adhesion and placentation depend on tissue plasminogen activator (tPA)-mediated activation of brain-derived neurotrophic factor, vascular endothelial growth factor and other growth factors, formation of hemidesmosomes, and degradation of extracellular matrix and basement membrane, either directly or by activating matrix metalloproteinases.
Since glucose and insulin stimulate release of a major tPA inhibitor by endothelial cells - plasminogen activator inhibitor (PAI)-1 - the investigators hypothesized that lifestyle interventions proven effective in maintaining glucose and insulin levels within the normal range would increase the take home baby rate in women undergoing assisted reproduction.
详细描述
Tissue plasminogen activator (tPA) has a well-known role in the coagulation pathway. tPA converts plasminogen to plasmin. Plasmin dissolves fibrin clots, thus limiting thrombus formation to the site of vascular injury.
In the extravascular compartment, tPA is a pivotal mediator of tissue formation and remodeling. Due to its proteolytic activity, tPA participates in processes as diverse as embryo adhesion, placental angiogenesis and vasculogenesis, and neuronal plasticity. Embryo adhesion and placentation, for example, depend on tPA-mediated activation of brain-derived neurotrophic factor, vascular endothelial growth factor and other growth factors, formation of hemidesmosomes, and degradation of extracellular matrix and basement membrane, either directly or by activating matrix metalloproteinases.
Assuming low tPA activity would impair both blood clot dissolution and placentation, the investigators postulated that patients with consecutive first-trimester abortions would have a high prevalence of severe dysmenorrhea, accompanied by the passage of large clots.
In 2011, the investigators assessed the prevalence of severe dysmenorrhea during early adolescence in two groups. The first one was made of women with ≥ 2 consecutive first-trimester abortions, and the other, of women with ≥ 2 living births, and no losses or preterm deliveries. Severe dysmenorrhea was defined as suprapubic menstrual cramp, intense enough to cause repeated absenteeism from school or fainting in the absence of analgesia. Early adolescents are unlikely to use contraceptives, or to have become pregnant, two situations that may reduce the pain. In this study, severe dysmenorrhea increased the chances of having consecutive first-trimester miscarriages by sevenfold (95% Confidence Interval: 3.4 to 14.1; p<0.001).
Since glucose and insulin stimulate release of a major tPA inhibitor by endothelial cells - plasminogen activator inhibitor (PAI)-1 - the investigators hypothesized that lifestyle interventions proven effective in maintaining glucose and insulin levels within the normal range would increase the take home baby rate in women undergoing assisted reproduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women undergoing assisted reproduction
排除标准
- •liver failure, kidney failure or other conditions that prevent the patient from eating proteins.
- •multiple pregnancy.
- •paraplegia, hemiplegia, arthropathy and other conditions that prevent the participant from exercising.
- •participants lost to follow-up.
- •conditions that may strongly affect pregnancy results, such as a serious accident
- •participants assigned to non-intervention group following the recommendations given to intervention group.
结局指标
主要结局
The rate of viable pregnancies
时间窗: two years
次要结局
- Maternal weight gain(four years)
- The rate of preeclampsia, eclampsia and HELLP syndrome(four years)
- Cramps or bleeding during the first trimester requiring progesterone(four years)
- The rate of intrauterine growth restriction(four years)
- The rate of gestational diabetes(four years)
- The rate of fist trimester losses(four years)
- The rate of prematurity(four years)
- The rate of neonatal hypoglycemia(four years)
- The rate of second and third trimester losses(four years)
- The rate of neonatal hyperbilirubinemia requiring phototherapy(four years)
研究者
Silvia Hoirisch Clapauch
MD, PhD
Hospital dos Servidores do Estado do Rio de Janeiro