Effect of Ultrasound Acupoints on Patients With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Serum insulin level
研究概览
简要总结
This study will be conducted to evaluate the effect of ultrasound acupoints on menstrual irregularity and hormone levels on polycystic ovary syndrome (PCOS) patient.
详细描述
PCOS is a life-long condition and although the exact cause is yet to be identified, it is believed to have epigenetic origins. It is the main gynecological endocrinopathy of reproductive age. It is the most common cause of infertility due to anovulation. In many countries, it represents the leading cause of female infertility.
Signs and symptoms are mediated by hormonal disorder including elevated androgens and fasting insulin, and abnormal relative ratio of the gonadotropins luteinizing hormone (LH) and follicle stimulating hormone (FSH). Endocrine imbalances occur within the framework of disordered ovarian folliculogenesis, chronic anovulation, clinical signs of hyperandrogenism and metabolic syndrome.
The standard treatment of PCOS includes oral medications, lifestyle changes, and surgery. Pharmacology-based treatments are effective in only 60% of patients. Therefore, acupuncture provides an alternative.
Acupuncture therapy in female with PCOS and ovulatory disorder has been known to bring enduring useful results on the endocrine system and menstrual cycle, without complications.
In women with PCOS and IR, acupuncture was superior to metformin in improving glucose metabolism and had a lower incidence of gastrointestinal adverse effects.
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
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adults range between 18 and 35 years.
- •All patients will be stopped drugs that affect the result during study period.
- •body mass index (BMI) not exceeding 30 kg/m
- •have the symptoms of oligomenorrhea or amenorrhea (appendix I).
- •No documented or observable psychiatric or neurological disorders that would interfere with study participation (eg, dementia or psychosis).
- •Not having any type of cancer.
排除标准
- •Any malignancy
- •Patients with severe or unstable cardiorespiratory or musculoskeletal diseases that may influence the accuracy of quantitative sensory testing results.
- •Participants who refuse to stop the drugs that affect the study during study period.
- •Contraindications to therapeutic ultrasound including active cancer in region of hands or feet, presence of deep vein thrombosis, complete numbness in hands or feet, metal or plastic implantation.
研究组 & 干预措施
Pulsed ultrasound at acupuncture points + Standard care program
It will consist of 22 patients, who will receive pulsed therapeutic ultrasound (1 MHz) at bilateral acupuncture points of St29, Sp6,and unilateral acupuncture points of Ren4, Ren5, in addition to standard care program.
干预措施: Pulsed ultrasound at acupuncture points (Other)
Pulsed ultrasound at acupuncture points + Standard care program
It will consist of 22 patients, who will receive pulsed therapeutic ultrasound (1 MHz) at bilateral acupuncture points of St29, Sp6,and unilateral acupuncture points of Ren4, Ren5, in addition to standard care program.
干预措施: Standard care program (Other)
Placebo ultrasound + Standard care program
It will consist of 22 patients, who will receive placebo therapeutic ultrasound in addition to standard care program.
干预措施: Placebo ultrasound at acupuncture points (Other)
Placebo ultrasound + Standard care program
It will consist of 22 patients, who will receive placebo therapeutic ultrasound in addition to standard care program.
干预措施: Standard care program (Other)
结局指标
主要结局
Serum insulin level
时间窗: 12 weeks
Blood samples will be obtained before intervention and 12 weeks after intervention by venepuncture for 20 seconds and transfer to the laboratory in gel tubes for measurement of serum insulin levels. Centrifugation will perform at 4600 rpm for 15 minutes. The Insulin Quantitative Tests are based on a solid phase enzyme-linked immunosorbent assay (ELISA). Sampling time of insulin will be an 8 -hour fasting specimen.
Serum Luteinizing Hormone (LH) level
时间窗: 12 weeks
Blood samples will be obtained before intervention and 12 weeks after intervention by venepuncture for 20 seconds and transfer to the laboratory in gel tubes for measurement of serum LH levels. Centrifugation will perform at 4600 rpm for 15 minutes. The LH Quantitative Tests are based on a solid phase enzyme-linked immunosorbent assay (ELISA). Sampling time of insulin will be an 8 -hour fasting specimen.
Serum Follicle Stimulating Hormone (FSH) level
时间窗: 12 weeks
Blood samples will be obtained before intervention and 12 weeks after intervention by venepuncture for 20 seconds and transfer to the laboratory in gel tubes for measurement of serum FSH levels. Centrifugation will perform at 4600 rpm for 15 minutes. The FSH Quantitative Tests are based on a solid phase enzyme-linked immunosorbent assay (ELISA). Sampling time of insulin will be an 8 -hour fasting specimen.
Testosterone level
时间窗: 12 weeks
Blood samples will be obtained before intervention and 12 weeks after intervention by venepuncture for 20 seconds and transfer to the laboratory in gel tubes for measurement of serum Testosterone levels. Centrifugation will perform at 4600 rpm for 15 minutes. The Testosterone Quantitative Tests are based on a solid phase enzyme-linked immunosorbent assay (ELISA). Sampling time of insulin will be an 8 -hour fasting specimen.
次要结局
- Ovarian volume(12 weeks)
- Number of cysts on ultrasound(12 weeks)
- Diameter of cysts on ultrasound(12 weeks)
研究者
Ola Fathy Elsayed Atwa Elsharabasy
Principal Investigator
Kafrelsheikh University