NCT05277948

Effect of Thumbtack Needle (TN) on Ovarian Reserve Function of Women With Diminished Ovarian Reserve (DOR)

Effect of Thumbtack Needle (TN) on Ovarian Reserve Function of Women With Diminished Ovarian Reserve (DOR): A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Dongmei Huang · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Diminished ovarian reserve (DOR) is the precursor state of ovarian failure, and can cause the decline of women's reproductive function. Some studies have demonstrated that acupuncture can improve ovarian reserve function. Thumbtack needle (TN), as a kind of acupuncture, is a form of long-term indwelling intradermal needle therapy. TN has been found effective in treating DOR in our clinic. In this study, a multi-center, large sample, randomized, patient-assessor blinded, sham-controlled clinical trial was used to evaluate the effect of TN on ovarian reserve function of patients with diminished ovarian reserve (DOR). 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 TN or sham TN for a total of 2 menstrual cycles. Fourth, the above baseline measurements will be taken again as soon as the treatment is finished and outcome measures will be recorded after the treatment. Last, Natural pregnancy outcomes includes natural pregnancy rate (including biochemical pregnancy rate, clinical pregnancy rate) and miscarriage rate during the treatment period and within 6 months after treatment completion will be followed up. Pregnancy outcome Includes number of oocytes retrieved, fertilization rate, embryo formation rate, blastocyst formation rate, biochemical pregnancy rate, clinical pregnancy rate and miscarriage rate during IVF-ET within 6 months after treatment completion will also be followed up.

Conditions

• Diminished Ovarian Reserve

Interventions

Type	Name	Description
OTHER	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.
OTHER	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

Timeline

• Start date: 2021-10-18
• Primary completion: 2025-11-28
• Completion: 2025-12-06
• First posted: 2022-03-14
• Last updated: 2026-02-25

Locations

1 site across 1 country: China