Clinical Efficacy of Acupuncture on the Liver Meridian in Women With Diminished Ovarian Reserve

NCT05743218 | Unknown

• 1 other identifier: 2019YFC1709104-1
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

Diminished ovarian reserve (DOR) refers to a decrease in the number and quality of oocytes in the ovary, which results in impaired ovarian function and decreased fertility. Meanwhile, levels of the anti-Müllerian hormone (AMH), antral follicle count (AFC), and Follicle-Stimulating Hormone (FSH) also decrease in patients with DOR. In general, there is a decline in fertility and premature menopause. Some patients will have low menstrual volume, oligomenorrhea or even amenorrhea, abnormal uterine bleeding, ovulation disorders, infertility and perimenopausal performance before the age of 40, and eventually develop into premature ovarian failure. In recent years, with the changes of social culture, living environment, work pressure and other factors, the incidence of this disease has increased year by year, which has a great impact on women's fertility, mental health, quality of life, family relations and other aspects. As a green and safe complementary and alternative therapy, acupuncture has been proved to be effective. According to the statistics, 904 (33.54%) of the 2695 syndromes indicated by acupoints of the liver meridian recorded in 93 ancient medical books are reproductive disorders, ranking first in the diseases indicated by the liver meridian and the 14 meridians. The body surface course of the liver meridian is closely related to the genitals, and there is a close relationship between the liver meridian and the genitals in physiology and pathology. According to the theory of the relationship between meridians and zangfu organs, the study aims to verify the efficacy and safety of acupuncture of the liver meridian and provide high-level research evidence for meridian syndrome differentiation of reproductive system diseases via "treatment from the liver."

Conditions

Ovarian Reserve; Acupuncture Therapy; Meridian

Outcome Measures

Primary Outcomes (1)

• The value of anti-mullerian hormone(AMH)

  This index is used to measure ovarian hormone secretion function and assess ovarian reserve function. Instrument:Beckman Coulter Access automatic immune analyzer. Method: Venous blood will be collected on an empty stomach at 3-5mL in the morning on the 2nd to 4th day of menstruation, centrifuged at 5000r/min for 3min with a high-speed centrifuge, and the upper serum is taken and stored in a -80℃ refrigerator for test. Unit: ng/mL.

  3 checkpoints. Baseline period(1 week before enrollment), enrollment 12 weeks (Change from Baseline at 12weeks) and enrollment 24 weeks(Changes at 12 weeks of treatment and 12 weeks of follow-up).

Secondary Outcomes (7)

• The number of antral follicle count (AFC)

  3 checkpoints. Baseline period(1 week before enrollment), enrollment 12 weeks (Change from Baseline at 12weeks) and enrollment 24 weeks(Changes at 12 weeks of treatment and 12 weeks of follow-up).

• Sex hormone: follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2）

  3 checkpoints. Baseline period(1 week before enrollment), enrollment 12 weeks (Change from Baseline at 12weeks) and enrollment 24 weeks(Changes at 12 weeks of treatment and 12 weeks of follow-up).

• The total score of the modified Kupperman scale

  3 checkpoints. Baseline period(1 week before enrollment), enrollment 12 weeks (Change from Baseline at 12weeks) and enrollment 24 weeks(Changes at 12 weeks of treatment and 12 weeks of follow-up).

• The total score of the perimenopausal quality of life score

  3 checkpoints. Baseline period(1 week before enrollment), enrollment 12 weeks (Change from Baseline at 12weeks) and enrollment 24 weeks(Changes at 12 weeks of treatment and 12 weeks of follow-up).

• The total score of the self-rating anxiety Scale

  3 checkpoints. Baseline period(1 week before enrollment), enrollment 12 weeks (Change from Baseline at 12weeks) and enrollment 24 weeks(Changes at 12 weeks of treatment and 12 weeks of follow-up).

Other Outcomes (12)

• White blood cell (WBC)

  Baseline period(1 week before enrollment), enrollment 12 weeks (Change from Baseline at 12weeks).

• Red blood cell (RBC)

  Baseline period(1 week before enrollment), enrollment 12 weeks (Change from Baseline at 12weeks)

• Blood platelet

  Baseline period(1 week before enrollment), enrollment 12 weeks (Change from Baseline at 12weeks)

Study Arms (3)

liver meridian group

EXPERIMENTAL

Four acupoints; LR3 Taichong, LR5 Ligou, LR8 Ququan, and LR12 Jiman. Based on the national standard of the People's Republic of China in 2006 (GB/T 12346-2006). The patient will be in a supine position. Taichong will be punctured at a 25-mm depth using a 0.35×25-mm filiform needle, Ligou will be punctured at a 15-20-mm depth with a 0.35×25-mm filiform needle, Ququan at a 20-25-mm depth with a 0.30×40-mm filiform needle, and an acute pulse of 15-20 mm. Each acupoint will be subject to a small amount of uniform lifting and twisting to the degree of local acid distension. An auxiliary needle (0.16×13 mm) will be inserted approximately 5 mm into the needle, 2 mm proximal to the heart of each acupoint along the meridian. The negative electrode will be connected to the main point, and the positive electrode will be connected to the auxiliary needle, and connect the electroacupuncture instrument. The needles will be retained for 30 min respectively, once every other day, 36 treatments.

Other: electropuncture

stomach meridian group

ACTIVE COMPARATOR

Four acupoints have been selected for the gastric meridian group, including ST42 Chongyang, ST40 Fenglong, ST36 Zusanli, and ST31 Biguan. The acupoint locations are based on the national standard of the People's Republic of China in 2006 (GB/T 12346-2006). The patient will be supine during the procedure, and the needles will be routinely sterilized. Straight needling will be performed in the hip region using a 0.30×50-mm-filiform needle, a 0.30×50-mm filiform needle in Zusanli, and a 0.30×40-mm filiform needle in Fenglong. A 0.35×25-mm filiform needle will be used to stimulate Chongyang for 10-15 mm, and each acupoint will be gently and evenly lifted, inserted, and twisted to local acid distension. Electroacupuncture will be applied in the same manner as for the liver meridian group. The needles will be retained for 30 min respectively, once every other day, then thrice weekly for a total of 36 treatments in the three groups.

Other: electropuncture

non-acupoint acupuncture group

PLACEBO COMPARATOR

Four points: (1) On the lateral thigh, between the vastus lateralis and biceps femoris, the midpoint of the popliteal stria, and the highest point of the greater trochanter. (2) On the lateral side of the calf, beside the level of Zusanli, and at the lateral edge of the tibia. (3) On the fibular side of the calf, the midpoint of the stomach meridian, and the bile meridian, 3 cm above the tip of the lateral malleolus and in front of the hanging bell. (4) On the lateral side of the calcaneus, and the servant enters the midpoint of the line connecting the posterior edge of the calcaneus at the same level. The 0.30×25-mm filiform needles are inserted straight for 3-5 mm at the points, the needles can stand without Deqi. The auxiliary needle will be inserted and electroacupuncture will be connected (same as in the other group). The internal wire of the electroacupuncture instrument will be interrupted, no current passed through. The treatment time is the same as the other two groups.

Other: electropuncture

Interventions

electropuncture OTHER

Electroacupuncture (EA) is a method of treating diseases by inserting a needle (usually a filiform needle) into the skin or tissue of a patient at a certain Angle, and then passing through the needle (sensing) micro-current waves of human bioelectricity to stimulate specific parts of the human body (acupoints). 1. Disposable sterile acupuncture filiform needle (0.16mm×13mm, 0.30mm×25mm, 0.30mm× 40mm), Guizhou Andi Medical Equipment Co, LTD, Guizhou Food and Drug Supervision and Equipment Production Xu 20170011. 2. Electroacupuncture apparatus: SDZ-Ⅱ electroacupuncture apparatus of Huatuo brand, Suzhou Medical Supplies Factory Co., LTD., Registration No. : 20172270675.

Also known as: acupuncture

liver meridian group; non-acupoint acupuncture group; stomach meridian group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with the detection indicators within 3 months before enrollment met the diagnostic criteria of DOR.
• patients aged between 18 and 40 years old.
• patients who have received no other treatment in the 2 months before enrollment. (4) patients who voluntarily participate in this study and can actively cooperate with the study process.
• (5) patients who have signed an informed consent form. Patients who meet all five criteria will be eligible for this study.

You may not qualify if:

• (1) Patients with polycystic ovarian syndrome, hyperprolactinemia, pituitary or hypothalamic amenorrhea, thyroid dysfunction, congenital malformations, and organic lesions in the reproductive organs.
• (2) Patients with a history of local ovarian surgery, such as oophorectomy and ovarian tumor surgery.
• (3) Patients with a history of chemotherapy or pelvic radiotherapy and a history of therapy with immunosuppressive agents.
• (4) Patients with comorbidities in the cardiovascular system, liver, kidney, hematopoietic system, nervous and mental system, diabetes, hypertension, and other diseases.
• (5) Patients being administered estrogen, progesterone, or dehydroepiandrosterone (DHEA) within 2 months before enrollment.
• (6) Patients who cannot tolerate blood or ultrasound testing. (vii) Patients who are also participating in other clinical trials.
• (7) Patients who refuse to sign the informed consent form. Patients who meet any of the above criteria will be excluded.

Sponsors & Collaborators

• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine: lead

Study Sites (1)

The First Affiliated Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, 410001, China

RECRUITING

Related Publications (18)

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MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Wei Zhang, Doctor

CONTACT

+86 135 4863 9198; 507395550@qq.com

Wenying Shi, Master

CONTACT

+86 138 7586 6937; 273727875@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: On account of the particularity of acupuncture research, it is impossible to blind acupuncture operators. Blinded evaluation will be adopted in the trial, and the third party who does not know the grouping will evaluate the efficacy. Blind statistical analysis was used in the data summary stage, and the researchers, operators and statisticians were separated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The subjects were randomly assigned to the liver meridian group, the stomach meridian group and the non-acupoint acupuncture groups group at a ratio of 1:1:1.

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 24, 2023
• Study Start: January 25, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)