Study of Acupoints in Diminished Ovarian Reserve Based on Biological Characteristics

NCT06395623 | Recruiting

• 1 other identifier: 2022YFC3500401
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diminished Ovarian Reserve

Keywords

Biological Characteristics; Acupoint

Outcome Measures

Primary Outcomes (2)

• Temperature of acupoint by infrared thermal image

  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.

  baseline

• Pain threshold

  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.

  baseline

Secondary Outcomes (3)

• Serum follicle-stimulating hormone (FSH)

  baseline

• Serum Anti-Müllerian Hormone (AMH)

  baseline

• The modified Kupperman Index(KI)

  baseline

Study Arms (2)

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).

Healthy participants

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

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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)\>

You may qualify if:

• 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):
• IU/L \< FSH \< 20 IU/L,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaomei Shao: lead
• Hangzhou Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, China

RECRUITING

Study Officials

• Xiaomei Shao

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomei Shao

CONTACT

+8618957130287; shaoxiaomei@zcmu.edu.cn

Hanyu Liu

CONTACT

+8617857314691; 912782196@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: March 24, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 6, 2024

Record last verified: 2024-04

Locations

CN (1)