Efficacy of Thumb-tack Needle Treatment for Diminished Ovarian Reserve: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- changes of serum follicle-stimulating hormone (FSH) level
研究概览
简要总结
Diminished Ovarian Reserve (DOR) is characterized as an important cause of infertility. Acupuncture has been extensively used to treat female infertility. This study was conducted to investigate the efficacy of thumb-tack needle，as a new special type of acupuncture and long-lasting treatment modality,in the treatment of DOR.
详细描述
There will be a multi-center, randomized, sham-controlled trial. 106 patients will be randomly assigned into thumb-tack needle acupuncture or sham-acupuncture in 1:1 ratio. All the patents will achieve 12 sessions of verum or sham treatments in 20 weeks(12 weeks for treatment and 8 weeks for follow-up). Patients, outcome assessors and statisticians are masked from group assignment. The study is aim to evaluate the efficacy of thumb-tack needle for DOR.
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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years old ≤ age < 40 years old, female;
- •Clinical diagnosis of Diminished Ovarian Reserve: meet both items in twice tests with an interval of at least 4 weeks(tested between 2rd to 4th day of menstrual cycle):
- •10 IU/L < FSH < 20 IU/L,
- •Anti-Müllerian hormone(AMH) < 1.1ng/mL.
- •without any mind disease, willing to participate in the study and sign the informed consent.
- •without any other treatment.
排除标准
- •Low or no response to exogenous gonadotropins, or with congenital anomalies in the development of the reproductive tract；
- •Pregnant or breastfeeding;
- •Abnormal body temperatures at the moment;
- •Psychopath, alcoholic, Patient with severe depression, history of substance abuse and severe primary diseases of cardiovascular, liver, kidney and hematopoietic system;
- •Currently enrolled in other clinical trials or refuse to cooperate with the study protocol.
结局指标
主要结局
changes of serum follicle-stimulating hormone (FSH) level
时间窗: baseline，week 4, week 12，week 20(week 8 in follow-up)
The increasing of serum follicle-stimulating hormone（FSH） is one of the main symptoms of Diminished Ovarian Reserve. The normal value of FSH is 1.37-9.9 U/L in follicular phase, and higher the FSH value, the worse ovarian function. Patients in this study will be asked to take the serum FSH text between day2 to day4 of menstrual period in whole observation. Patients with amenorrhea take every 28 days as a supposed menstrual cycle instead.
次要结局
- the modified Kupperman Index(KI)(baseline，week 4, week 12，week 20(week 8 in follow-up))
- Self-Rating Anxiety Scale (SAS)(baseline，week 4, week 12，week 20(week 8 in follow-up))
- temperature of sensitized acupoint(baseline，week 4, week 12，week 20(week 8 in follow-up))
- Self-rating Depression Scale (SDS)(baseline，week 4, week 12，week 20(week 8 in follow-up))
- changes of 1.Serum Anti-Müllerian Hormone (AMH) level(baseline，week 12, week 20(week 8 in follow-up))
- pain threshold of sensitized acupoint(baseline，week 4, week 12，week 20(week 8 in follow-up))
- Psychological constitution of traditional Chinese medicine(TCM）(baseline，week 4, week 12，week 20(week 8 in follow-up))
研究者
Xiaomei Shao
Professor
The Third Affiliated hospital of Zhejiang Chinese Medical University