Evaluation on Biological Characteristics of Acupoints in Premature Ovarian Insufficiency
- Conditions
- Premature Ovarian Insufficiency
- Interventions
- Device: all patients and healthy people will receive at least 3 infrared thermal imaging examinations of acupoints and pain threshold examinations of acupoints.
- Registration Number
- NCT06145061
- Lead Sponsor
- Xiaomei Shao
- Brief Summary
Acupuncture has been widely used in the treatment of Premature Ovarian Insufficiency(POI), but the selection of acupoints is indeterminate and lacks biological basis.In recent years,some studies suggested the "acupoint sensitization",that is,changes such as pain sensitivity and heat sensitivity appear on the acupoints under disease state.The biological characteristics of acupoints can reflect the state of local tissue and might be a potential factor for guiding acupoint selection. This study aims to compare the temperature and pain threshold of acupoints between POI patients and the healthy population.At the meantime,clinical diagnosis of POI is based on clinical symptoms and Follicle Stimulating Hormone (FSH).However,FSH fluctuates so much that prediction accuracy is not high and clinical application is limited.Therefore, given the lack of proper diagnostic accuracy in POI and the concept of "acupoint sensitization",it is necessary to summarize the changes of biological characteristics of related acupoints under physiological and pathological conditions as an auxiliary means to improve the diagnostic rate of POI.
- Detailed Description
The study is a case-control study protocol involving 150 POI patients from three clinical centers and 150 healthy persons in China.The duration of the study is one year, and all patients and healthy people will receive at least 3 infrared thermal imaging examinations of acupoints and pain threshold examinations.The primary outcome is to investigate the difference in the skin temperature and pain threshold of acupoints between POI and healthy persons.In the meanwhile,we will collect FSH, serum estradiol (E2) and some relevant scales,including modified Kupperman Index,Zung's Self-Rating Anxiety Scale(SAS),Zung's Self-Rating Depression Scale(SDS),Traditional Chinese medicine(TCM) constitution scale as second outcomes.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- POI patient inclusion criteria:1.meet the diagnostic criteria for POI:POI diagnostic criteria refer to the 2016 European Society for Reproductive Medicine POI guidelines:Age < 40 years; Oligomenorrhea or amenorrhea for at least 4 months; Two measurements (on day 2-4 of the menstrual cycle, at least 4 weeks apart)Follicle Stimulating Hormone（FSH） > 25 IU/L and meet the above three requirements.
2.18 years old ≤ age < 40 years old, gender female; 3.They are conscious and able to communicate normally. 4.Provide recent transvaginal ultrasound or pelvic color Doppler ultrasound examination report to determine the menstrual cycle.
5.Those who understand and are willing to comply with the study protocol and sign the informed consent form.
Healthy volunteers inclusion criteria:1.Healthy subjects who can provide physical examination report within the past 1 year and have routine physical examination by the investigator, and confirm that they have no serious underlying diseases such as reproductive system, urinary system, blood, endocrine system and nervous system;2.Currently no symptoms of oligomenorrhea or amenorrhea;3.18 years ≤ age < 40 years, female;4.Those who understand and are willing to comply with the study protocol and sign the informed consent form.
- POI patient exclusion criteria:Patients who met any of the following criteria were excluded:1.low response or no response to exogenous gonadotropin, congenital reproductive tract dysplasia;2.Subjects who are pregnant or lactating;3.Patients with abnormal body temperature were found before detection;4.patients with mental illness, severe depression, alcohol dependence, history of drug abuse or serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system; 5.Patients who do not cooperate with the study protocol of this study
Healthy volunteers exclusion criteria:volunteers who met any of the following criteria were excluded:1.mentally ill patients, patients with severe depression, alcohol dependence or those with a history of drug abuse;2.Subjects who are pregnant or lactating;3.volunteers with abnormal body temperature before testing;4.Those who do not cooperate with the study protocol of this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description healthy subjects all patients and healthy people will receive at least 3 infrared thermal imaging examinations of acupoints and pain threshold examinations of acupoints. Healthy subjects:1.Healthy subjects who can provide physical examination report within the past 1 year and have routine physical examination by the investigator, and confirm that they have no serious underlying diseases such as reproductive system, urinary system, blood, endocrine system and nervous system;2.Currently no symptoms of oligomenorrhea or amenorrhea;3.18 years ≤ age \< 40 years, female;4.Those who understand and are willing to comply with the study protocol and sign the informed consent form. POI patients all patients and healthy people will receive at least 3 infrared thermal imaging examinations of acupoints and pain threshold examinations of acupoints. POI patients:1.meet the diagnostic criteria for POI:POI diagnostic criteria refer to the 2016 European Society for Reproductive Medicine POI guidelines:Age \< 40 years; Oligomenorrhea or amenorrhea for at least 4 months; Two measurements (on day 2-4 of the menstrual cycle, at least 4 weeks apart)Follicle Stimulating Hormone（FSH） \> 25 IU/L and meet the above three requirements.2.18 years old ≤ age \< 40 years old, gender female; 3.They are conscious and able to communicate normally.4.Provide recent transvaginal ultrasound or pelvic color Doppler ultrasound examination report to determine the menstrual cycle.5.Those who understand and are willing to comply with the study protocol and sign the informed consent form.
- Primary Outcome Measures
Name Time Method The difference in the temperature and pain threshold of acupoints between POI and healthy populations Baseline,6 months after,12 months after. The primary objective of this study is to investigate the difference in the temperature and pain threshold of acupoints between POI and healthy populations.
- Secondary Outcome Measures
Name Time Method Follicle Stimulating Hormone Baseline,6 months after,12 months after. Clinical diagnosis of POI is based on clinical symptoms and Follicle Stimulating Hormone (FSH).However,FSH fluctuates so much that prediction accuracy is not high and clinical application is limited
Traditional Chinese medicine(TCM) constitution scale Baseline,6 months after,12 months after. TCM constitution scale is Prepared by Professor Wang Qi of Beijing University of Chinese Medicine, in order to evaluate peoplr's TCM constitution.Constitution classification is the basis and core content of TCM constitution research, which is to extract the relevant laws from the complex constitution phenomenon and finally build the constitution classification system.There are 9 items and 66 small items in the TCM constitution scale, which are required to be filled in according to the real situation in the last year. The results of the scale include nine constitutions: mild constitution, qi deficiency constitution, qi depression constitution, yin deficiency constitution, yang deficiency constitution, blood stasis constitution, special constitution, phlegm-dampness constitution and damp-heat constitution.
Zung's Self-Rating Depression Scale(SDS) Baseline,6 months after,12 months after. The SDS can reflect the depressive state and its variability well (Zung, 1965). The scale contains 20 items scored on a 4-point scale. The rough scores were obtained by summing each of the 20 new items, multiplying the rough scores by 1.25, and then taking the integer part as the standard score. A standard score of 50-59 is considered to be a mild depressive mood, a standard score of 60-69 is considered to be moderate depression, and a standard score of more than 70 is considered to be severe depression. Patients respond according to their situation in the past week.
Modified Kupperman Baseline,6 months after,12 months after. The modified Kupperman Index consists of 13 items . In addition to the same 11 items included in the original Index,the modified version adds urogenital symptoms, including urinary infection and sexual complaints. The original 11 items included sweating/hot flushes, palpitation, vertigo, headache, paresthesia, formication, arthralgia, and myalgia (categorized as somatic symptoms), and fatigue, nervousness, and melancholia categorized as psychological symptoms. A scale ranging from 0 to 3 points is used to describe the severity of the complaints. The weighting factors were the same as those used in the original KI, and provide two points for both urogenital symptoms. The total score ranges from 0 to 63, calculated as the sum of all items by the weighting factor. Scores ranging from 0-6, 7-15, 16-30, and \>30 were used to rate the degree of severity as none, mild, moderate, and severe, respectively.
Zung's Self-Rating Anxiety Scale(SAS) Baseline,6 months after,12 months after. The SAS is used to assess the subjective feelings of patients with anxiety. SAS has good psychometric credentials, and it is suitable for all types of psychiatric disorders in which anxiety symptoms are predominant. There are 20 items on a four-point scale, and higher scores indicate greater anxiety.SAS has good psychometric credentials and can assist in the assessment of patients' anxiety status.
Trial Locations
- Locations (1)
the Third affiliated hospital of Zhejiang Chinese Medical university
🇨🇳Hangzhou, Zhejiang, China