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Effect of Thumbtack Needle (TN) on Ovarian Reserve Function of Women With Diminished Ovarian Reserve (DOR)
Sponsor: Dongmei Huang
Summary
Using a multi-center, large sample, randomized, patient-assessor blinded, sham-controlled clinical trial to evaluate the effect of thumbtack needle (TN) on ovarian function of patients with diminished ovarian reserve (DOR).
Official title: Effect of Thumbtack Needle (TN) on Ovarian Reserve Function of Women With Diminished Ovarian Reserve (DOR): A Randomized Controlled Clinical Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2021-10-18
Completion Date
2025-12-06
Last Updated
2026-09-01
Healthy Volunteers
No
Conditions
Interventions
active TN and ETN treatment
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 acupoints of CV4, CV3, SP6, ST36 and BL23 will be treated by disposable sterile thumbtack needle (TN) for single use (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM2-6YDL), and four acupoints of bilateral ovary acupoints and bilateral EX-B7 will be treated by disposable sterile electro-thumbtack needle (ETN) (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM3-ZY) with pulsed electrical stimulation. The patients will receive a treatment of 2 menstrual cycles.
sham TN and sham ETN treatment
The acupoints used in the control group are the same as those in the treatment group. Eight points of CV4, CV3, SP6, ST36 and BL23 will be treated by the sterile sham thumbtack needle (TN) for single use (Hangzhou Zhuomai Medical Technology Co., LTD.), and four points of bilateral ovary acupoints and bilateral EX-B7 will be treated by disposable sterile sham electro-thumbtack needle (ETN) (Hangzhou Zhuomai Medical Technology Co., LTD.) with sham pulsed electrical stimulation. The sham TN and ETN used in this group are identical in appearance, shape, and color to the active TN and ETN but lack the needle body, thus lacking the needle-penetrating effect. The stimulation method and frequency for the sham ETN are the same as those of the ETN group. The only difference is that the electrode pads used in the sham ETN group are specially designed as insulated controls. The patients will receive a treatment of 2 menstrual cycles
Locations (1)
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China