Phase 3 Study Investigating the Effect of Endobarrier Treatment on Fertility in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change in egg quality or ovulation rate after Endobarrier treatment
研究概览
简要总结
Women with Polycystic ovary syndrome (PCOS) experience multiple fertility treatments, a long treatment duration and a low pregnancy prevalence. This syndrome is frequently accompanied by overweight and insulin resistance which can mediate the limited response to fertility treatment. The Endobarrier device was shown to be efficient in weight and glucose lowering. The aim of this study is to investigate the ability of the Endobarrier device to improve the outcome of fertility treatments in women with PCOS.
详细描述
- PCOS Polycystic ovary syndrome (PCOS) is the most common endocrinopathy among women of reproductive age, associated with reproductive and metabolic dysfunction with a prevalence of 5-10% of reproductive aged women.
Diagnostic criteria vary and according to the Rotterdam ESHRE/ASRM- Sponsored PCOS Consensus Workshop Group PCOS is defined when at least two of the following three criteria are present: [i] polycystic ovaries, by ultrasound [ii] oligo and/or anovulation, and [iii] clinical and/or biochemical signs of hyperandrogenism.
The clinical presentation varies from amenorrhea and a sonographic picture of polycystic ovaries but with subtle phenotypic abnormalities or signs of hyperandrogenism, to advanced Stein and Leventhal syndrome with clinical heterogeneity as the rule. Moreover, women with PCOS might exhibit features of the metabolic syndrome, including impaired glucose tolerance (IGT), obesity and dyslipidaemia ,with their associated long- term sequelae, namely endometrial carcinoma, hypertension, type 2 diabetes (T2D) and cardiovascular disease.
Impaired Glucose Intolerance (IGT) and PCOS Impaired glucose tolerance, or insulin resistance, are defined as decreased insulin-mediated glucose utilization. It has long been recognized as a major risk factor for diabetes. Moreover, it was shown that lifestyle intervention or metformin in patients with IGT, may reduce the prevalence of T2D. Several dynamic invasive tests and calculated indices are currently available for detecting IGT. While the euglycemic clamp technique is considered the most accurate test for the assessment of insulin resistance, this cumbersome test is frequently replaced by the simple measurement of the ratio of fasting glucose to fasting insulin, or the 2-hour glucose level after a 75-g oral glucose tolerance test (OGTT) (WHO criteria, impaired glucose tolerance [IGT] >140 mg/dL to 199 mg/dL). As a result, reports of the prevalence on IGT in women with PCOS vary depending on the sensitivity and specificity of the tests employed and the heterogenic phenotypes of PCOS.
Obesity - definition, significance and prevalence among women with PCOS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subjects taking systemic corticosteroids or drugs known to affect GI motility within 30 days prior to randomization
- •Subjects receiving any prescription or over the counter weight loss medication within 30 days prior to the Endobarrier insertion procedure (including GLP-1 analogs).
- •Known Diabetes as defined by: fasting plasma glucose ≥126 mg/dL or any plasma glucose ≥200 mg/dL or HbA1c level ≥6.5% .
- •Previous GI surgery that could preclude the ability to place the EndoBarrier device, liner or affect the function of the implant
- •Subjects with a history of abnormal GI anatomical findings documented on imaging study, which in the opinion of the Investigator, may impair implantation of the EndoBarrier device
- •Subjects with active GERD not taking a Proton Pump Inhibitor (PPI), which in the investigator's opinion might interfere with the Endobarrier.
- •Subjects with symptomatic kidney stones within 6 months prior to randomization.
- •Known abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or Crohn's disease, atresias or stenoses, upper gastro-intestinal bleeding conditions
- •Subjects with symptomatic gallstones within 6 months prior to randomization
- •Coagulopathy defined as hgb <10g/dl and platelet < 100,000/ml or diagnosis of hemophilia, factor X deficiencies or fibrinogen abnormalities
- •Any documented history of acute or chronic pancreatitis
- •Subjects requiring prescription antithrombotic therapy (i.e. anticoagulant or antiplatelet agent)
- •Subjects unable to discontinue Aspirin or any other NSAIDs (non-steroidal anti-inflammatory drugs) or any other drugs with bleeding as a potential side effect (i.e coumadin) during the study duration
- •Known diagnosis of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- •Subject is or has been enrolled in another investigational study within 3 months of participation into the EndoBarrier study
- •Subjects with poor dentition who cannot completely chew their food.
- •Subjects with thyroid disease unless controlled with a therapeutic dose of medication and have normal thyroid function tests for a minimum of 6 months prior to randomization
- •Subjects not residing within a 3 hour driving distance of the study center.
- •Subjects with an abnormal laboratory or ECG abnormality which the investigators deems clinically significant and makes the patient a poor candidate for the study
- •Subjects with known allergies or hypersensitivity to ceftrixone, cephalosporins or penicillin.
- •The investigator may decide to exclude the participation of a subject due to medical, safety or any other reason (i.e; behavioral issues, etc.) at any point before the implantation procedure.
研究组 & 干预措施
IVF treatment
Fertility, as determined by egg quality parameters, as well as metabolic parameters, will be assessed following Endobarrier treatment in PCOS during IVF treatment.
干预措施: Endobarrier treatment in PCOS (Device)
clomiphene citrate treatment
Ovulation rate in response to clomiphen citrate after Endobarrier treatment in PCOS.
干预措施: Endobarrier treatment in PCOS (Device)
clomiphene citrate treatment
Ovulation rate in response to clomiphen citrate after Endobarrier treatment in PCOS.
干预措施: clomiphene citrate treatment (Drug)
结局指标
主要结局
change in egg quality or ovulation rate after Endobarrier treatment
时间窗: 2.5 years
Different fertility parameters will be tested during IVF treatment after endobarrier treatment: Total number of retrieved oocytes, Number of oocytes in M2, Number of 2PN, Top quality embryos on day of transfer, Number of embryos transferred Number of follicles above 15 mm,E2 on day of HCG, Number of embryos frozen. Ovulation in response to Clomiphene citrate will also be assessed.
次要结局
- percent change in Triglycerides(6 months)
- percent change in HbA1c(6 months)
- percent change in LDL cholesterol(6 months)
- percent change in HDL cholesterol(6 months)
- percent change in body mass index(6 months)
- percent change in waist circumference(6 months)
- percent change in fasting plasma glucose levels(6 months)
研究者
Dr. Gabriella Segal-Lieberman
Endocrinologist
Sheba Medical Center