Study of Acupoints in Diminished Ovarian Reserve Based on Biological Characteristics

NCT ID: NCT06395623

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-24

Study Completion Date

2025-12-30

Brief Summary

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Diminished Ovarian Reserve (DOR) is characterized by decreased female fertility, menstrual disorders and perimenopausal symptoms due to sex hormone deficiency or fluctuations. For now, there are no uniform diagnostic criteria or an ideal single detection index for DOR because of its insidious etiology and pathogenesis,theories suggest that there are specific changes in the body surface or acupuncture points in a pathological state. By detecting the biological characteristics of relevant meridian points and exploring the specificity and regularity of it.

Detailed Description

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There will be a multi-center, case-control, observational experiment. 50 patients with DOR and 50 healthy participants will be involved from Third Affiliated Hospital of Zhejiang Chinese Medicine University, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medicine University and social recruitment. Modern instruments are used to regularly test the pain threshold, infrared thermal image, resistance, micro-circulation, and biological ultra-weak luminescence. There will be no randomized methods and blindness for subjects, while assessors and statisticians are masked from patients or healthy people. The study is aim to explore the the relevance between meridian acupoints and DOR.

Conditions

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Diminished Ovarian Reserve

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with DOR

50 patients diagnosed with DOR will be recruited in this group to get detectionsof pain threshold, infrared thermal image, resistance, micro-circulation, and biological ultra-weak luminescence at the relevant body surface areas and meridian acupoints and the blood test of serum FSH(follicle-stimulating hormone) and AMH(Anti-Müllerian Hormone).

No interventions assigned to this group

Healthy participants

50 healthy participants in this group will achieve the same detections of biological characteristics and blood test as well.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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

* 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.


* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hangzhou Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Xiaomei Shao

OTHER

Sponsor Role lead

Responsible Party

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Xiaomei Shao

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiaomei Shao

Role: PRINCIPAL_INVESTIGATOR

The Third Affiliated hospital of Zhejiang Chinese Medical University

Locations

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the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaomei Shao

Role: CONTACT

+8618957130287

Hanyu Liu

Role: CONTACT

+8617857314691

Facility Contacts

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Xiaomei Shao

Role: primary

+8618957130287

Hanyu Liu

Role: backup

+8617857314691

Other Identifiers

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2022YFC3500401

Identifier Type: -

Identifier Source: org_study_id

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