Study of Acupoints in Diminished Ovarian Reserve Based on Biological Characteristics

Recruiting

• Conditions: Diminished Ovarian Reserve

• Registration Number: NCT06395623
• Lead Sponsor: Xiaomei Shao

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.

Study Timeline

• Study Start: 2024-03-24
• Status Verified: 2024-04
• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-02
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain threshold	baseline	Pain threshold of related acupoints will be tested by pressure pain threshold gauge (PTG). Assessors will put continuous pressure on the surface of acupoints vertically until participants feel pain to measure the threshold.
Temperature of acupoint by infrared thermal image	baseline	Infrared thermography (The NEC R550 infrared thermal imager and the InfRec Analyzer NS9500 computer software) will be used to measured the temperature of the meridian acupoints. The measurements are taken at participants' follicular phase.

Secondary Outcome Measures

Name	Time	Method
Serum Anti-Müllerian Hormone (AMH)	baseline	AMH is another recommend index to measure ovarian function. Compared to FSH, Anti-Müllerian Hormone has less fluctuation and more accuracy. The normal value of serum AMH is 2-6.8ng/ml in follicular phase, and lower the value, the worse condition. The serum AMH will be measured on day 2-4 of the menstrual cycle at the basement and the end of the treatment.
Serum follicle-stimulating hormone (FSH)	baseline	The increasing of FSH is widely clinical accepted for measuring ovarian function, which is one of the main symptoms of Diminished Ovarian Reserve. Participants in this study will be asked to take the serum FSH text between day2 to day4 of menstrual period in whole observation.
The modified Kupperman Index(KI)	baseline	The modified Kupperman Index (KI) is widely used for female self-evaluation of the severity of menopausal symptoms in clinical practice. It values 13 items of menopausal symptoms on a scale of 0 to 3. The final score of KI is the sum of each score multiplied with the base score respectively, ranging from 0-63. The final KI score is less than 6 means normal, between 6 to 15 are classified as mild, 16 to 30 as moderate, and greater than 30 as severe.

Trial Locations

Locations (1)

the Third affiliated hospital of Zhejiang Chinese Medical university; 🇨🇳 Hangzhou, Zhejiang, China