The Impact of Different Ovarian Hyperstimulation Protocols on Coagulation and Fibrinolysis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Fibrin clot properties before and after the ovarian hyperstimulation.
研究概览
简要总结
The impact evaluation of ovarian hyperstimulation on coagulation and fibrinolysis in infertile women.
Comparative analysis between different ovarian stimulation protocols on thrombin formation and efficiency of fibrinolysis in women diagnosed with infertility.
详细描述
Infertility is a common problem. Assisted reproductive techniques (ART) increases the chance of getting pregnant by couples undergoing such treatment. Unfortunately, the numer of live births after ART remains still low. Over the past three decades, physicians have tried to improve infertility diagnosis and increase its successful treatment. An effort aimed at increasing effectivenes of diagnosis resulted in hypothesis that one of probable reasons of infertility may be the occurrence of microclots, which worsen implantation and embryos development. There are currently no published studies describing the effects of different ovarian hyperstimulation protocols on hemostasis (coagulation and fibrinolysis).
The parameters of thrombin generation and efficiency of fibrinolysis will be evaluated in women qualified for ovarian hyperstimulation. The study may improve the effectiveness of ART.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •infertility defined based on the WHO 2010 criteria
排除标准
- •ovarian involvement
- •oral contraceptives use within previous 3 months
- •dienogest therapy within 3 months until ART
- •thrombotic events in the medical history
- •severe hypertension
- •diabetes mellitus
- •the presence of known VTE risk factors, including obesity, recent major surgery with prolonged immobilization or trauma,
- •deficiency of antithrombin, protein C or protein S,
- •antiphospholipid syndrome,
- •known malignancy,
- •any chronic inflammatory diseases (e.g. rheumatoid arthritis)
- •advanced chronic renal disease (estimated glomerular filtration rate [eGFR] <30 ml/min),
- •international normalized ratio (INR) more than 1.2 at the day of blood draw
- •pregnancy.
结局指标
主要结局
Fibrin clot properties before and after the ovarian hyperstimulation.
时间窗: 4 months
Coagulation (endogenous thrombin potential) and fibrinolysis (F1+2, clot lysis time)parameters assessment.
次要结局
- Endometriosis and fibrin clot properties.(1 cycle)
研究者
Magdalena Piróg, MD
Principal Investigator
Jagiellonian University