Effect of Thumbtack Needle on Ovarian Function of Women With Diminished Ovarian Reserve (DOR)
NCT ID: NCT05277948
Last Updated: 2022-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2021-09-01
2026-10-31
Brief Summary
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Detailed Description
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First, patients will be recruited according to the inclusion criteria and exclusion criteria.
Second, baseline measurements (including ovarian reserve function, blood biochemical index, scores from the self-rating anxiety and depression scale, quality of life, sleep status) will be taken.
Third, each patient will receive the treatment of thumbtack needle for a total of 2 menstrual cycles.
Last, the above baseline measurements will be taken again as soon as the treatment is finished and outcome measures will be recorded after the treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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treatment group
Active thumbtack needle will be used for the treatment group
active thumbtack needle
The following 12 acupoints including conception vessel (CV) 4, CV3, bilateral ovary acupoints, bilateral spleen (SP) 6, bilateral stomach (ST) 36, bilateral bladder (BL) 23 and bilateral EX-B7 will be used. Eight points of CV4, CV3, SP6, ST36 and BL23 were treated by the sterile thumbtack needle for single use (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM2-6YDL), and four points of bilateral ovary acupoints and bilateral EX-B7 were treated by disposable sterile electro-thumbtack needle (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM3-ZY).
The patients were receive a treatment of 2 menstrual cycles
control group
Sham thumbtack needle will be used for the control group
sham thumbtack needle
The following 12 acupoints including conception vessel (CV) 4, CV3, bilateral ovary acupoints, bilateral spleen (SP) 6, bilateral stomach (ST) 36, bilateral bladder (BL) 23 and bilateral EX-B7 will be used. Eight points of CV4, CV3, SP6, ST36 and BL23 were treated by the sterile sham thumbtack needle for single use (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM2-6YDL), and four points of bilateral ovary acupoints and bilateral EX-B7 were treated by disposable sterile sham electro-thumbtack needle (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM3-ZY).
The patients were receive a treatment of 2 menstrual cycles
Interventions
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active thumbtack needle
The following 12 acupoints including conception vessel (CV) 4, CV3, bilateral ovary acupoints, bilateral spleen (SP) 6, bilateral stomach (ST) 36, bilateral bladder (BL) 23 and bilateral EX-B7 will be used. Eight points of CV4, CV3, SP6, ST36 and BL23 were treated by the sterile thumbtack needle for single use (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM2-6YDL), and four points of bilateral ovary acupoints and bilateral EX-B7 were treated by disposable sterile electro-thumbtack needle (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM3-ZY).
The patients were receive a treatment of 2 menstrual cycles
sham thumbtack needle
The following 12 acupoints including conception vessel (CV) 4, CV3, bilateral ovary acupoints, bilateral spleen (SP) 6, bilateral stomach (ST) 36, bilateral bladder (BL) 23 and bilateral EX-B7 will be used. Eight points of CV4, CV3, SP6, ST36 and BL23 were treated by the sterile sham thumbtack needle for single use (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM2-6YDL), and four points of bilateral ovary acupoints and bilateral EX-B7 were treated by disposable sterile sham electro-thumbtack needle (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM3-ZY).
The patients were receive a treatment of 2 menstrual cycles
Eligibility Criteria
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Inclusion Criteria
* Low ovarian reserve: AMH\<1.1ng/ml; or AFC\<7; or 10 U/L\<FSH\<25U/L or FSH/LH\>3.6; or has a history of poor ovarian response, that is, in the last controlled hyperstimulation cycle, the number of retrieved oocytes\<3. Any 2 of the above 4 conditions are met.
* Sign informed consent voluntarily.
Exclusion Criteria
* Patients with previous ovarian surgery because of such as ovarian teratoma or chocolate cyst and so on.
* Patients with uncorrected endocrine disease, such as: Simple hyperthyroidism or hypothyroidism, hyperprolactinemia, insulin resistance, diabetes, adrenal diseases, etc.
* Patients with definitively diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, Sjogren's syndrome, Hashimoto's thyroiditis.
* Patients with a history of cancer and has received radiotherapy or chemotherapy.
* Patients had the treatment of acupuncture or thumbtack needle in recent 3 months.
* Patients who take Chinese medicine decoction or granule during the treatment;
* Patients unwilling to sign the informed consent of this study.
18 Years
40 Years
FEMALE
No
Sponsors
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Huazhong University of Science and Technology
OTHER
Responsible Party
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Dongmei Huang
associate Professor
Principal Investigators
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Hanwang Zhang
Role: PRINCIPAL_INVESTIGATOR
Huazhong University of Science Tech
Locations
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Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Effect of TTN on DOR
Identifier Type: -
Identifier Source: org_study_id
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