Exploring Acupoints in Women with Diminished Ovarian Reserve
Study of Acupoints in Diminished Ovarian Reserve Based on Biological Characteristics：A Case-control Study
This study is trying to see how certain acupuncture points might be linked to the health of women with Diminished Ovarian Reserve compared to healthy women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | Female |
| Sponsor | The Third Affiliated hospital of Zhejiang Chinese Medical University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06395623 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the biological characteristics of acupoints in women diagnosed with Diminished Ovarian Reserve (DOR) compared to healthy participants. It involves a multi-center approach with 50 patients and 50 healthy controls, utilizing modern instruments to assess various biological parameters such as pain threshold and micro-circulation. The study aims to uncover the relationship between specific meridian acupoints and the condition of DOR, providing insights into potential diagnostic criteria. No randomization or blinding is applied to subjects, but assessors remain masked to ensure unbiased data collection.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 40 with a clinical diagnosis of Diminished Ovarian Reserve.
Not a fit: Patients with significant underlying health issues or those currently undergoing other treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of Diminished Ovarian Reserve and lead to improved diagnostic methods for women facing fertility challenges.
How similar studies have performed: While the approach of using acupoints in relation to DOR is relatively novel, similar studies in acupuncture have shown promising results in other areas of women's health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion criteria for patient with DOR: * 18 years old ≤ age \< 40 years old, female; * Clinical diagnosis of Diminished Ovarian Reserve: meet both items in twice tests with an interval of at least 4 weeks(tested between 2rd to 4th day of menstrual cycle): 1. 10 IU/L \< FSH \< 20 IU/L, 2. Anti-Müllerian hormone(AMH) \< 1.1ng/mL. * without any mind disease, willing to participate in the study and sign the informed consent. * without any other treatment. Inclusion criteria for healthy participants: * healthy participants who can provide medical examination reports within the past 1 year and have routine physical examination conducted by researchers to confirm that there are no serious underlying diseases of the reproductive system, urinary system, blood, endocrine, nervous system, etc.; * without symptoms of oligomenorrhea or amenorrhea at present; * between the ages of 18 to 40, female; * without any mind disease, volunteering to participate in the study and sign the informed consent. Exclusion Criteria: Exclusion Criteria for patient with DOR * Low or no response to exogenous gonadotropins, or with congenital anomalies in the development of the reproductive tract; * Pregnant or breastfeeding; * Abnormal body temperatures at the moment; * Psychopath, alcoholic, Patient with severe depression, history of substance abuse and severe primary diseases of cardiovascular, liver, kidney and hematopoietic system; * Currently enrolled in other clinical trials or refuse to cooperate with the study protocol. Exclusion Criteria for healthy participants * Patient with mental illness, severe depression, alcohol dependence or a history of drug abuse; * In pregnant or breastfeeding; * abnormal body temperature at present; * Participants who are currently participating in other clinical trials or who do not cooperate with the study protocol.
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 — The Third Affiliated hospital of Zhejiang Chinese Medical University
- Study coordinator: Xiaomei Shao
- 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.