Does Low-frequency Electro-acupuncture Restore Sensitivity of the Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Frequent blood sampling every 10th minute during an overnight stay in order to measure changes in LH and cortisol pulsatility before and after treatment. A third assessment will be made in those participants who ovulate during the 14 week study.
研究概览
简要总结
Hypothesis The overall hypothesis is that non-obese (BMI <30) women with PCOS have high luteinising hormone (LH) and cortisol pulse frequency and amplitude and that repeated low-frequency EA restore these alterations and induce ovulation.
详细描述
Aim 1. Elucidate if low-frequency EA induce ovulation and restore LH frequency and amplitude as well as sex steroid secretion as compared to a control group receiving same amount of attention.
Aim 2. Elucidate if low-frequency EA restore cortisol frequency and amplitude compared to a control group receiving same amount of attention.
Aim 3. Elucidate if low-frequency EA restore psychological distress and quality of life as compared to a control group receiving same amount of attention.in women with PCOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 - 39 years, inclusive
- •History of irregular menstrual cycles
- •Clinical and/or biochemical androgen excess (determined during screening)
排除标准
- •Medical Exclusion Criteria
- •History or clinical manifestation of; cardiovascular disease, diabetes (Type 1 or Type 2), any other significant endocrine or metabolic disorder.
- •Regular use of medications for weight control, psychosis and thyroid disease. A 3 month washout period will be permitted for contraceptives.
- •Psychiatric and Behavioral Exclusion Criteria
- •Pregnant or breast-feeding women
研究组 & 干预措施
Meeting a therapist - attention
干预措施: Meeting a therapist - attention control (Other)
Low-frequency electro-acupuncture
干预措施: Low-frequency electro-acupuncture (EA) (Device)
结局指标
主要结局
Frequent blood sampling every 10th minute during an overnight stay in order to measure changes in LH and cortisol pulsatility before and after treatment. A third assessment will be made in those participants who ovulate during the 14 week study.
时间窗: 16 weeks
次要结局
- Ovulation, health related quality of life(16 weeks)