Evaluating Acupoint Characteristics in Women with Premature Ovarian Insufficiency
Evaluation on Biological Characteristics of Acupoints in Premature Ovarian Insufficiency:A Case-control Study Protocol.
This study is testing the differences in skin temperature and pain sensitivity at specific acupuncture points in women with Premature Ovarian Insufficiency compared to healthy women to help improve acupuncture treatments for this condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | The Third Affiliated hospital of Zhejiang Chinese Medical University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06145061 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the biological characteristics of acupoints in women diagnosed with Premature Ovarian Insufficiency (POI) compared to healthy individuals. It will involve 150 POI patients and 150 healthy controls, who will undergo infrared thermal imaging and pain threshold testing at three clinical centers in China. The primary goal is to assess differences in skin temperature and pain sensitivity at acupoints, while secondary outcomes will include hormonal assessments and various health scales. The findings may provide insights into more accurate acupoint selection for acupuncture treatment in POI.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 to 40 who meet the diagnostic criteria for Premature Ovarian Insufficiency.
Not a fit: Patients outside the age range of 18 to 40 or those with serious underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of acupuncture treatments for women suffering from Premature Ovarian Insufficiency.
How similar studies have performed: While acupuncture has been studied for various conditions, this specific approach focusing on acupoint sensitization in POI is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hangzhou, Zhejiang
- the Third affiliated hospital of Zhejiang Chinese Medical university — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Xiaomei Shao, Ph.D — The Third Affiliated hospital of Zhejiang Chinese Medical University
- Study coordinator: Xiaomei Shao, Ph.D
- Email: shaoxiaomei@zcmu.edu.cn
- Phone: +8618957130287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.