Acupuncture as a Complementary Therapy for Infertile Patients on Treatment With in Vitro Fertilization: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Quality of life
研究概览
简要总结
This is an open-label randomized controlled trial of the use of acupuncture in infertile patients receiving In Vitro Fertilization (IVF). Patients will be randomized into two groups: treatment group will receive acupuncture as a complementary approach to IVF and control group will receive the IVF treatment. Groups will be compared with the World Health Organization quality of life (WHOQOL-Bref), short-form 36 (SF-36), State Trait Anxiety Inventory (STAI) and Scope-Stress questionnaires.
详细描述
This is an open-label randomized controlled trial of the use of acupuncture in infertile patients receiving In Vitro Fertilization (IVF). Patients will be randomized into two groups: treatment group will receive acupuncture as a complementary approach to IVF and control group will receive the IVF treatment. Groups will be compared with the World Health Organization quality of life (WHOQOL-Bref), short-form 36 (SF-36), State Trait Anxiety Inventory (STAI) and Scope-Stress questionnaires. In addition, data from medical records of infertile patients submitted to in vitro fertilization for treatment of infertility will be compared in the two different treatment groups (with and without acupuncture), such as the required dose of drugs for the treatment, number of ovarian follicles, number of oocytes captured, quality of oocytes, number of embryos, quality of embryos, pregnancy and abortion rates.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patient
- •age over 18 years
- •diagnosis of infertility with indication of IVF
- •agreement accept to participate in the study
- •signature of the consent form
排除标准
- •history of previous contact with the acupuncture technique
- •severe neurological or psychiatric disorders that make it impossible to participate in the study
结局指标
主要结局
Quality of life
时间窗: after 8 acupuncture sessions (up to 12 weeks of follow-up)
Quality of life evaluation by the WHOQOL-Bref questionnaire
次要结局
- Quality of life 2(after 8 acupuncture sessions (up to 12 weeks of follow-up))
- Stress(after 8 acupuncture sessions (up to 12 weeks of follow-up))
- Pregnancy rate(after 8 acupuncture sessions (up to 12 weeks of follow-up))
- Quality of life 3(after 8 acupuncture sessions (up to 12 weeks of follow-up))
研究者
Rubens Lene Carvalho Tavares
Professor
Federal University of Minas Gerais