The Clinical Trial of Electro-thumbtack Needle on Live Birth Rate in Patients With Ovarian Reserve Dysfunction (DOR)

NCT07142187 | Not Yet Recruiting DMC

• 1 other identifier: TJ-IRB202508011
• Study Type: interventional
• Target: 368
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will include 246 patients with ovarian reserve dysfunction (DOR), who will be randomly divided into a treatment group and a control group, with 123 patients in each group. The treatment group will receive electro-thumbtack needle treatment, while the control group will receive placebo electro-thumbtack needle treatment. Both groups will receive a treatment course of 3 menstrual cycles. This study evaluates the effect of electrocautery on the live birth rate of patients with DOR.

Conditions

Diminished Ovarian Reserve (DOR)

Outcome Measures

Primary Outcomes (1)

• live birth rate

  The live birth rate is defined as the proportion of live births after 28 weeks of pregnancy, usually calculated by dividing the number of live birth cycles by the total number of patients and multiplying by 100%. This indicator is commonly used to evaluate the effectiveness of reproductive health centers or specific treatment methods, reflecting the ultimate outcome of successful pregnancy.

  3 months

Secondary Outcomes (26)

• Biochemical pregnancy rate

  3 months

• clinical pregnancy rate

  3 months

• Threatened miscarriage rate

  3 months

• abortion rate

  3 months

• Anti Mullerian hormone (AMH)

  3 months

Study Arms (2)

electro-thumbtack needle group

EXPERIMENTAL

Electro-thumbtack needle is a sterile needle with a special conductive chip that can conduct electricity. Electro-thumbtack needle enhances the stimulation effect on acupoints by introducing pulsed microcurrents, and is a long-lasting needle retention therapy with stronger stimulation effect than ordinary acupressure.

Other: electro-thumbtack needle

Placebo group

PLACEBO COMPARATOR

Placebo electro-thumbtack needle use insulated soft silk threads instead of needle bodies, making their appearance, shape, and color no different from real electro-thumbtack needle, but without needle like effects; Placebo electro-thumbtack needle also do not have the conductivity of true electric needles (silk threads are insulated); The placebo conductive patch used in the control group, although having the same appearance as the treatment group, is a specially insulated control substance. Therefore, even if the pulse generator is turned on and adjusted to medium intensity, the patient still receives zero current stimulation intensity.

Other: placebo electro-thumbtack needle

Interventions

electro-thumbtack needle OTHER

The treatment acupoints include bilateral ovarian acupoints, Guan Yuan (CV4), bilateral Shen Shu (BL23), bilateral waist and eye acupoints (EX-B7), bilateral San Yin Jiao (SP6), and bilateral Zu San Li (ST36), totaling 11 acupoints. Among them, the bilateral ovarian acupoints and bilateral waist eye acupoints (EX-B7) were treated with electro-thumbtack needle. Other acupoints were treated with thumbtack needle.Choose a sparse and dense waveform, adjust the intensity to the maximum patient can tolerate, and stimulate for 30 minutes each time. After the stimulation is completed, remove the electrode patch and electroacupuncture device, and keep the electric needle at the acupoint for another 3 days.During the needle retention period, the electric needles at the bilateral ovarian acupoints and bilateral waist and eye acupoints were alternately stimulated once every other day using an electroacupuncture device for 30 minutes each time.

electro-thumbtack needle group

placebo electro-thumbtack needle OTHER

The control group selected acupoints that were the same as the treatment group. Bilateral ovarian acupoints and bilateral waist and eye acupoints are treated with placebo electro-thumbtack needle, while other acupoints are treated with placebo electro-thumbtack needle. The treatment methods for placebo electro-thumbtack needle and placebo thumbtack needle are the same as those for the treatment group.

Placebo group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The age range is 18-40 years old;
• Meets the diagnostic criteria for DOR as follows: ① AMH\<1.1 ng/ml; ② 10 U/L \< FSH \< 25U/L or FSH/LH \> 3.6; ③ The total number of follicles (AFC) in both basal sinuses is less than 7. If any two of the above criteria (①②③) are met, it can be diagnosed as DOR.
• At least one side of the patient's fallopian tube is unobstructed;
• The semen routine examination of the patient's spouse is normal;
• Voluntarily sign the informed consent form.

You may not qualify if:

• Chromosomal or genetic abnormalities in either the female or male partner;
• Women with blocked fallopian tubes on both sides;
• Have a history of ovarian surgery, such as ovarian teratoma or ovarian chocolate cyst surgery;
• The female party suffers from uncorrected endocrine disorders such as simple hyperthyroidism or hypothyroidism, hyperprolactinemia, and pancreatic islet dysfunction;
• Hormone resistance, diabetes, adrenal diseases, etc;
• The woman has a clearly diagnosed autoimmune disease such as systemic lupus erythematosus, rheumatoid arthritis;
• Antiphospholipid syndrome, Sjogren's syndrome, Hashimoto's thyroiditis, etc;
• The female or male partner has a history of malignant tumors and has received treatment with radiotherapy and chemotherapy;
• The woman has received acupuncture and moxibustion or press acupuncture treatment in recent 3 months;
• Those who take traditional Chinese medicine decoctions or granules during treatment;
• Men with abnormal semen examination;
• Clear diagnosis of moderate or severe adenomyosis;
• Clearly diagnose uterine fibroids with a diameter greater than 5cm;
• I do not agree to sign the informed consent form for this study.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Integrated Traditional Chinese and Western Medicine at Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: August 26, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 30, 2029
• Study Completion (Estimated): October 30, 2029
• Last Updated: August 26, 2025

Record last verified: 2025-08