NCT00565240已完成不适用
Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women Protocol: WHIRL-07-2971
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- To evaluate differences in the mechanisms of atresia, initiation of a new synchronous follicular wave, interval to follicle wave emergence, interval to emergence of dominant follicle, interval to menstruation, and endometrial thickness/pattern.
研究概览
简要总结
We hypothesize that administration of an aromatase inhibitor (AI) and hormonal contraceptives (HC) in the mid-luteal phase of the menstrual cycle will result in atresia of the follicles in the extant wave and cause synchronous re-emergence of a new follicular wave. We anticipate that this will provide us with information to facilitate the development of a new method for ovarian synchronization; a safer, more effective ovulation induction therapy; a new method for emergency contraception; and a greater understanding of human folliculogenesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female volunteers of childbearing potential;
- •are first time users of OC or have discontinued OC at least 2 months prior to study entry;
- •age between 18 and 35 years old;
- •normal body mass index (18-30);
- •has signed consent form; and
- •is in good health as confirmed by medical history, physical examination
排除标准
- •a positive pregnancy test will automatically exclude the volunteer from participation in this study.
- •any contraindication for oral contraception use;
- •known hypersensitivity to Letrozole and co-administered medications;
- •irregular menstrual cycles;
- •ultrasonographic evidence of ovarian dysfunction, such as Polycystic Ovary Syndrome (PCOS);
- •history of pituitary tumor;
- •HIV, HBV, HCV infection;
- •vaginal infection;
- •abnormal ECG;
- •abnormal lab tests for blood profile, liver function and renal function;
- •uncontrolled diabetes and blood pressure;
- •pregnancy (suspected or diagnosed) or lactation;
- •history or suspicion of drug or alcohol abuse;
- •history of severe mental disorders;
- •participation in an investigational drug trial within the 30 days prior to selection;
- •exhibits a disorder that is a contraindication to steroid hormonal therapy, including, for example, the following conditions:
- •history of, or actual, thrombophlebitis or thromboembolic disorders.
- •history of, or actual, cerebrovascular disorders.
- •history of, or actual, myocardial infarction or coronary artery disease.
- •acute liver disease.
- •history of, or actual, benign or malignant liver tumors.
- •history of, or suspected, carcinoma of the breast.
- •known, or suspected, estrogen-dependent neoplasia.
- •undiagnosed abnormal vaginal bleeding.
- •any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual field.
研究组 & 干预措施
Oral Contraceptive
Experimental
干预措施: Marvelon (Drug)
Contraceptive Ring
Experimental
干预措施: Nuvaring (Drug)
Aromatase Inhibitors
Experimental
干预措施: Letrozole (Drug)
结局指标
主要结局
To evaluate differences in the mechanisms of atresia, initiation of a new synchronous follicular wave, interval to follicle wave emergence, interval to emergence of dominant follicle, interval to menstruation, and endometrial thickness/pattern.
时间窗: 24-28 days
次要结局
- To evaluate between treatment group differences in ultrasonographic image attributes of follicular structures that develop after administration of treatment.(ongoing)
研究者
研究点 (1)
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