Study of Acupoints in Diminished Ovarian Reserve Based on Biological Characteristics：A Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain threshold
研究概览
简要总结
Diminished Ovarian Reserve (DOR) is characterized by decreased female fertility, menstrual disorders and perimenopausal symptoms due to sex hormone deficiency or fluctuations. For now, there are no uniform diagnostic criteria or an ideal single detection index for DOR because of its insidious etiology and pathogenesis,theories suggest that there are specific changes in the body surface or acupuncture points in a pathological state. By detecting the biological characteristics of relevant meridian points and exploring the specificity and regularity of it.
详细描述
There will be a multi-center, case-control, observational experiment. 50 patients with DOR and 50 healthy participants will be involved from Third Affiliated Hospital of Zhejiang Chinese Medicine University, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medicine University and social recruitment. Modern instruments are used to regularly test the pain threshold, infrared thermal image, resistance, micro-circulation, and biological ultra-weak luminescence. There will be no randomized methods and blindness for subjects, while assessors and statisticians are masked from patients or healthy people. The study is aim to explore the the relevance between meridian acupoints and DOR.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for patient with DOR:
- •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.
- •Inclusion criteria for healthy participants:
- •healthy participants who can provide medical examination reports within the past 1 year and have routine physical examination conducted by researchers to confirm that there are no serious underlying diseases of the reproductive system, urinary system, blood, endocrine, nervous system, etc.;
- •without symptoms of oligomenorrhea or amenorrhea at present;
- •between the ages of 18 to 40, female;
- •without any mind disease, volunteering to participate in the study and sign the informed consent.
排除标准
- •Exclusion Criteria for patient with DOR
- •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.
- •Exclusion Criteria for healthy participants
- •Patient with mental illness, severe depression, alcohol dependence or a history of drug abuse;
- •In pregnant or breastfeeding;
- •abnormal body temperature at present;
- •Participants who are currently participating in other clinical trials or who do not cooperate with the study protocol.
结局指标
主要结局
Pain threshold
时间窗: baseline
Pain threshold of related acupoints will be tested by pressure pain threshold gauge (PTG). Assessors will put continuous pressure on the surface of acupoints vertically until participants feel pain to measure the threshold.
Temperature of acupoint by infrared thermal image
时间窗: baseline
Infrared thermography (The NEC R550 infrared thermal imager and the InfRec Analyzer NS9500 computer software) will be used to measured the temperature of the meridian acupoints. The measurements are taken at participants' follicular phase.
次要结局
- Serum Anti-Müllerian Hormone (AMH)(baseline)
- Serum follicle-stimulating hormone (FSH)(baseline)
- The modified Kupperman Index(KI)(baseline)
研究者
Xiaomei Shao
Professor
The Third Affiliated hospital of Zhejiang Chinese Medical University