Evaluation on Biological Characteristics of Acupoints in Premature Ovarian Insufficiency

NCT06145061 | Recruiting

• 1 other identifier: 2023ZX010-POI
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Ovarian Insufficiency

Keywords

Acupuncture; Biological Characteristics of Acupoint Representation; infrared thermal imaging; pain threshold testing

Outcome Measures

Primary Outcomes (1)

• The difference in the temperature and pain threshold of acupoints between POI and healthy populations

  The primary objective of this study is to investigate the difference in the temperature and pain threshold of acupoints between POI and healthy populations.

  Baseline,6 months after,12 months after.

Secondary Outcomes (5)

• Modified Kupperman

  Baseline,6 months after,12 months after.

• Zung's Self-Rating Anxiety Scale(SAS)

  Baseline,6 months after,12 months after.

• Zung's Self-Rating Depression Scale(SDS)

  Baseline,6 months after,12 months after.

• Traditional Chinese medicine(TCM) constitution scale

  Baseline,6 months after,12 months after.

• Follicle Stimulating Hormone

  Baseline,6 months after,12 months after.

Study Arms (2)

POI patients

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.

Device: all patients and healthy people will receive at least 3 infrared thermal imaging examinations of acupoints and pain threshold examinations of acupoints.

healthy subjects

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.

Device: all patients and healthy people will receive at least 3 infrared thermal imaging examinations of acupoints and pain threshold examinations of acupoints.

Interventions

all patients and healthy people will receive at least 3 infrared thermal imaging examinations of acupoints and pain threshold examinations of acupoints. DEVICE

Infrared thermal imaging detection scheme of acupoints:Detection equipment NEC R550 infrared thermal imager.Records the corresponding acupoints coordinates,and starts to collect the infrared thermal image.and 6 images will be taken continuously for each detected part.The infrared thermograms were stored and extract the temperature values of the corresponding coordinates of the acupoints.The average temperature values of the acupoints in the six infrared thermograms were calculated as their temperatures.Pain threshold detection scheme of acupoints:The instrument and equipment use the FDX25 hand-held pain threshold test instrument to explore the acupoints.Place the probe of the pain measuring instrument vertically on the pain measuring acupoint, slowly and steadily press downward at a constant speed, and stop pressing immediately when the subject begins to feel pain. At this point, the reading on the display is the subject's pain threshold. All acupoints shall be measured once in total.

POI patients; healthy subjects

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.
• Those who understand and are willing to comply with the study protocol and sign the informed consent form.

Sponsors & Collaborators

• Xiaomei Shao: lead

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Xiaomei Shao, Ph.D

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomei Shao, Ph.D

CONTACT

+8618957130287; shaoxiaomei@zcmu.edu.cn

Haomin Sun

CONTACT

+8615990031347; 295783018@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: November 22, 2023
• Study Start: March 1, 2023
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

CN (1)