Clinical trial NCT06145061: Evaluation on Biological Characteristics of Acupoints in Premature Ovarian Insufficiency
Official title: Evaluation on Biological Characteristics of Acupoints in Premature Ovarian Insufficiency:A Case-control Study Protocol.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Premature Ovarian Insufficiency
Keywords: Acupuncture
Biological Characteristics of Acupoint Representation
infrared thermal imaging
pain threshold testing
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature Ovarian Insufficiency refers to the clinical symptoms of ovarian dysfunction in women before the age of 40, mainly manifested as abnormal menstruation,elevated gonadotropin levels and fluctuating decline in estrogen levels.Currently,POI is diagnosed clinically in patients \<40 years of age with abnormal menstruation (amenorrhea or oligomenorrhea\>4 months) and FSH\>25U/L (two consecutive measurements more than 4 weeks apart).However,FSH fluctuates so much that prediction accuracy is not high and clinical application is limited.The global incidence of POI is 1%,and it is about 2.8% in China.In the long run, POI patients face various health risks, such as increased incidence of cardiovascular diseases, bone and joint diseases, genitourinary diseases, psychological diseases,etc.,and may even lead to shortened life expectancy, which seriously endangers women's physical, psychological and social aspects.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The difference in the temperature and pain threshold of acupoints between POI and healthy populations
timeFrame: Baseline,6 months after,12 months after.
Secondary outcomes:
measure: Modified Kupperman
timeFrame: Baseline,6 months after,12 months after.
measure: Zung's Self-Rating Anxiety Scale(SAS)
timeFrame: Baseline,6 months after,12 months after.
measure: Zung's Self-Rating Depression Scale(SDS)
timeFrame: Baseline,6 months after,12 months after.
measure: Traditional Chinese medicine(TCM) constitution scale
timeFrame: Baseline,6 months after,12 months after.
measure: Follicle Stimulating Hormone
timeFrame: Baseline,6 months after,12 months after.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Third affiliated hospital of Zhejiang Chinese Medical university
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Xiaomei Shao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: