Premature Ovarian InsufficiencyNCT06145061
Evaluation on Biological Characteristics of Acupoints in Premature Ovarian Insufficiency
An observational study of Premature Ovarian Insufficiency, run by Xiaomei Shao at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Ovarian Insufficiency
- What is being tested?
- all patients and healthy people will receive at least 3 infrared thermal imaging examinations of acupoints and pain threshold examinations of acupoints.
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Third affiliated hospital of Zhejiang Chinese Medical university
Hangzhou, Zhejiang
Xiaomei Shao, Ph.D, +8618957130287, shaoxiaomei@zcmu.edu.cn
About this study
Official title: Evaluation on Biological Characteristics of Acupoints in Premature Ovarian Insufficiency:A Case-control Study Protocol.
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.
Read the 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.
- Conditions
- Premature Ovarian Insufficiency
- Being tested
- all patients and healthy people will receive at least 3 infrared thermal imaging examinations of acupoints and pain threshold examinations of acupoints.
- Keywords
- Acupuncture, Biological Characteristics of Acupoint Representation, infrared thermal imaging, pain threshold testing
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: all patients and healthy people will receive at least 3 infrared thermal imaging examinations of acupoints and pain threshold examinations of acupoints. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline,6 months after,12 months after.
Secondary outcomes (5)
Modified Kupperman
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.
Measured: Baseline,6 months after,12 months after.
Zung's Self-Rating Anxiety Scale(SAS)
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.
Measured: Baseline,6 months after,12 months after.
Zung's Self-Rating Depression Scale(SDS)
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.
Measured: Baseline,6 months after,12 months after.
Traditional Chinese medicine(TCM) constitution scale
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.
Measured: Baseline,6 months after,12 months after.
Follicle Stimulating Hormone
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
Measured: Baseline,6 months after,12 months after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Mar 2023
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaomei Shao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaomei Shao, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Xiaomei Shao, Ph.D, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145061
- Sponsor's protocol ID
- 2023ZX010-POI
- Status last verified
- Nov 2023
- First submitted
- 18 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation on Biological Characteristics of Acupoints in Premature Ovarian Insufficiency:A Case-control Study Protocol.
- ClinicalTrials.gov ID
- NCT06145061
- Acronym / sponsor ID
- 2023ZX010-POI
- Conditions
- Premature Ovarian Insufficiency
- Keywords
- Acupuncture, Biological Characteristics of Acupoint Representation, infrared thermal imaging, pain threshold testing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xiaomei ShaoUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POI patients | – | Device: 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. |
| healthy subjects | – | 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: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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| all patients and healthy people will receive at least 3 infrared thermal imaging examinations of acupoints and pain threshold examinations of acupoints.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. | Device | POI patients, healthy subjects |
Primary outcome
The difference in the temperature and pain threshold of acupoints between POI and healthy populations
Time frame: 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.
5 secondary outcomes
Modified Kupperman
Time frame: Baseline,6 months after,12 months after.
Zung's Self-Rating Anxiety Scale(SAS)
Time frame: Baseline,6 months after,12 months after.
Zung's Self-Rating Depression Scale(SDS)
Time frame: Baseline,6 months after,12 months after.
Traditional Chinese medicine(TCM) constitution scale
Time frame: Baseline,6 months after,12 months after.
Follicle Stimulating Hormone
Time frame: Baseline,6 months after,12 months after.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaomei Shao, Ph.D principal investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ovarian Insufficiency, run by Xiaomei Shao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaomei Shao, Ph.D (+8618957130287, shaoxiaomei@zcmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the temperature and pain threshold of acupoints between POI and healthy populations (time frame: Baseline,6 months after,12 months after.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.