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

Dongmei Huang240 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

240

Conditions

Diminished Ovarian Reserve

Interventions

active TN and ETN treatmentOTHER

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 treatmentOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with age between 18 and 40 years; * 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: * Patient's chromosome is abnormal. * 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.

Locations (1)

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Outcomes

Primary Outcomes

Evaluating the change of serum AMH level

Assessing patients' serum level of AMH in ng/ml at baseline (0 week) and immediately (up to 4 weeks) after treatment completion.

Time frame: 0 week and up to 4 weeks after treatment completion

Evaluating the change of the ovarian antral follicle count (AFC)

Counting the number of ovarian antral follicle count (AFC) on the second day of menstruation at baseline (0 week) and immediately (up to 4 weeks) after treatment completion.

Time frame: 0 week and up to 4 weeks after treatment completion

Secondary Outcomes

Evaluating the serum levels of sex hormones

Evaluating the serum levels of sex hormones (FSH, LH, E2, P, T, and PRL) on the second day of menstruation at baseline and immediately (up to 4 weeks) after treatment completion.

Time frame: 0 week and up to 4 weeks after treatment completion

Natural pregnancy outcomes include natural pregnancy rate and miscarriage rate

Natural pregnancy outcomes include natural pregnancy rate (including biochemical pregnancy rate, and clinical pregnancy rate) and miscarriage rate during the treatment period and within 6 months after treatment completion.

Time frame: 0 week and within 6 months after treatment completion

Pregnancy outcomes of IVF-ET within 6 Months after Treatment Completion

Pregnancy outcomes Include 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.

Time frame: 0 week and within 6 months after treatment completion

Observing the level of transforming growth factor β (TGF β) in follicular fluid

Data from ClinicalTrials.gov

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