Response of Menstrual Irregularity and Infertility- Related Stress to Ultrasound Cavitation Combined With Aerobic Exercise in PCOS: Double Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- cortisol level
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. Women with this syndrome may have infrequent menstrual periods or amenorrhea and excess androgen levels. The ovaries develop numerous small follicles and fail to ovulate on a regular basis, with subsequent subfertility in those women that wish to conceive. Recent research stated that interventions aiming to improve QoL among infertile women with PCOS should focus on alleviating infertility-related stress, especially among women with high BMI. So, the purpose of this study is to investigate the effect of ultrasound cavitation combined with aerobic exercise on menstrual irregularity and infertility related stress in women having 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
- Double (Participant, Outcomes Assessor)
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
- 未提供
结局指标
主要结局
cortisol level
时间窗: change from base line at 12 weeks.
Saliva samples will be collected with study participants sitting upright in a comfortable position and tilting the head forward, allowing the saliva to pool on the floor of the mouth
Infertily related Stress level
时间窗: change from base line at 12 weeks.
Infertility-Related Stress Scale is a concise, reliable, and validated tool; it facilitates quick screening for infertility's impact on intrapersonal and interpersonal life domains. The IRSS consists of 12 items rated from 1 ("no stress") to 7 ("high stress")., with higher grades means higher stress.
次要结局
- Hormonal profile(change from base line at 12 weeks.)
- Anthrometric measurement (body mass index and waist-hip ratio)(change from base line at 12 weeks.)
研究者
Marwa Shafiek Mustafa Saleh
assistance professor doctor
Cairo University