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

Huazhong University of Science and Technology

Status: Not yet enrolling

Conditions: Diminished Ovarian Reserve (DOR)

Treatments: Other: electro-thumbtack needle; Other: placebo electro-thumbtack needle

Study type: Interventional

Funder types: Other

Identifiers

NCT07142187

TJ-IRB202508011

Details and patient eligibility

About

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.

Enrollment: 368 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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368 participants in 2 patient groups, including a placebo group

electro-thumbtack needle group

Experimental group

Description:

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.

Treatment:

Other: electro-thumbtack needle

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Other: placebo electro-thumbtack needle