Clinical trial NCT06395623: Study of Acupoints in Diminished Ovarian Reserve Based on Biological Characteristics
Official title: Study of Acupoints in Diminished Ovarian Reserve Based on Biological Characteristics：A Case-control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diminished Ovarian Reserve
Keywords: Biological Characteristics
Acupoint
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
Collaborators: name: Hangzhou Hospital of Traditional Chinese Medicine
First posted: 2024-05-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study targets at patients with DOR and healthy participants. The diagnostic criteria of DOR were based on\<Consensus on Cinical Diagnosis and Management of Diminished Ovarian Reserve(2022)\> and \<Obstetrics and Gynecology(9th edition)\>

Brief summary: 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: 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.

Eligibility 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.

Primary outcomes:
measure: Temperature of acupoint by infrared thermal image
timeFrame: baseline
measure: Pain threshold
timeFrame: baseline
Secondary outcomes:
measure: Serum follicle-stimulating hormone (FSH)
timeFrame: baseline
measure: Serum Anti-Müllerian Hormone (AMH)
timeFrame: baseline
measure: The modified Kupperman Index(KI)
timeFrame: baseline
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Third affiliated hospital of Zhejiang Chinese Medical university
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Xiaomei Shao
role: PRINCIPAL_INVESTIGATOR
References: