Overview
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.
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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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