Clinical Efficacy of Acupuncture on the Liver Meridian in Women With Diminished Ovarian Reserve
NCT ID: NCT05743218
Last Updated: 2023-02-24
Study Results
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Basic Information
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UNKNOWN
NA
198 participants
INTERVENTIONAL
2023-01-25
2023-12-31
Brief Summary
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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."
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Detailed Description
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The main evaluation index will be Anti-Müllerian hormone(AMH), The secondary evaluation index include serum sex hormones (bFSH, bE2, bLH, bFSH/bLH), antral follicle count(AFC),, menstrual status, the modified Kupperman Index(KI), perimenopausal quality of life score (MENQOL) ,Self-Rating Anxiety Scale( SAS ), self-rating depression scale(SDS), Menstrual conditions. The patients were evaluated at different time points during the baseline period, treatment period and follow-up period, and the incidence of adverse events will be recorded. Double data entry will be used in this trial to ensure the accuracy of data entry. A three-level quality control system (self-inspection by each center, supervision by project management team, and third-party audit) was implemented to ensure that the implementation, recording and reporting of clinical trials were in accordance with the trial protocol, standard operating procedures, and relevant laws and regulations. The statistical analysis plan was developed by the statistical analysis principal and the principal investigators in accordance with the protocol and was finalized before the database was locked. The tables for the statistical analysis were developed. Statistical analysis will be calculated by SPSS25.0 statistical analysis software, P\<0.05 (i.e., =0.05) will be considered statistically significant, in order to clarify the efficacy and safety of acupuncture on DOR.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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liver meridian group
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.
electropuncture
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.
stomach meridian group
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.
electropuncture
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.
non-acupoint acupuncture group
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.
electropuncture
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.
Interventions
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electropuncture
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. patients aged between 18 and 40 years old.
3. 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.
Exclusion Criteria
(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.
18 Years
40 Years
FEMALE
No
Sponsors
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The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
OTHER
Responsible Party
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Locations
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The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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References
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Zhao L, Chen J, Li Y, Sun X, Chang X, Zheng H, Gong B, Huang Y, Yang M, Wu X, Li X, Liang F. The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial. JAMA Intern Med. 2017 Apr 1;177(4):508-515. doi: 10.1001/jamainternmed.2016.9378.
Liu CZ, Xie JP, Wang LP, Liu YQ, Song JS, Chen YY, Shi GX, Zhou W, Gao SZ, Li SL, Xing JM, Ma LX, Wang YX, Zhu J, Liu JP. A randomized controlled trial of single point acupuncture in primary dysmenorrhea. Pain Med. 2014 Jun;15(6):910-20. doi: 10.1111/pme.12392. Epub 2014 Mar 17.
Practice Committee of the American Society for Reproductive Medicine. Electronic address: [email protected]; Practice Committee of the American Society for Reproductive Medicine. Testing and interpreting measures of ovarian reserve: a committee opinion. Fertil Steril. 2020 Dec;114(6):1151-1157. doi: 10.1016/j.fertnstert.2020.09.134.
Sun W, Stegmann BJ, Henne M, Catherino WH, Segars JH. A new approach to ovarian reserve testing. Fertil Steril. 2008 Dec;90(6):2196-202. doi: 10.1016/j.fertnstert.2007.10.080. Epub 2008 Apr 22.
Cohen J, Chabbert-Buffet N, Darai E. Diminished ovarian reserve, premature ovarian failure, poor ovarian responder--a plea for universal definitions. J Assist Reprod Genet. 2015 Dec;32(12):1709-12. doi: 10.1007/s10815-015-0595-y. Epub 2015 Oct 13.
Wang Y, Li Y, Chen R, Cui X, Yu J, Liu Z. Electroacupuncture for reproductive hormone levels in patients with diminished ovarian reserve: a prospective observational study. Acupunct Med. 2016 Oct;34(5):386-391. doi: 10.1136/acupmed-2015-011014. Epub 2016 May 13.
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Birch S, Lee MS, Kim TH, Alraek T. On defining acupuncture and its techniques: A commentary on the problem of sham. Integr Med Res. 2022 Jun;11(2):100834. doi: 10.1016/j.imr.2022.100834. Epub 2022 Jan 8. No abstract available.
Hong L, Peng S, Li Y, Fang Y, Wang Q, Klausen C, Yin C, Wang S, Leung PCK, Yang X. miR-106a Increases Granulosa Cell Viability and Is Downregulated in Women With Diminished Ovarian Reserve. J Clin Endocrinol Metab. 2018 Jun 1;103(6):2157-2166. doi: 10.1210/jc.2017-02344.
Brinkhaus B, Hummelsberger J, Kohnen R, Seufert J, Hempen CH, Leonhardy H, Nogel R, Joos S, Hahn E, Schuppan D. Acupuncture and Chinese herbal medicine in the treatment of patients with seasonal allergic rhinitis: a randomized-controlled clinical trial. Allergy. 2004 Sep;59(9):953-60. doi: 10.1111/j.1398-9995.2004.00540.x.
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Other Identifiers
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2019YFC1709104-1
Identifier Type: -
Identifier Source: org_study_id
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