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

Официальное название

The Effect of Electro-thumbtack Needle on Live Birth Rate in Patients With Ovarian Reserve Dysfunction (DOR): a Multicenter Randomized Controlled Clinical Trial

Обзор

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.

Вмешательства

• Другое electro-thumbtack needle
  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 to
• Другое placebo electro-thumbtack needle
  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.

Первичные конечные точки

• live birth rate [Срок оценки: 3 months]

Вторичные конечные точки (12)

• Biochemical pregnancy rate [Срок оценки: 3 months]
• clinical pregnancy rate [Срок оценки: 3 months]
• Threatened miscarriage rate [Срок оценки: 3 months]
• abortion rate [Срок оценки: 3 months]
• Anti Mullerian hormone (AMH) [Срок оценки: 3 months]
• Antral Follicle Count (AFC) [Срок оценки: 3 months]
• follicle stimulating hormone（FSH） [Срок оценки: 3 months]
• Luteinizing hormone (LH) [Срок оценки: 3 months]
• estradiol（E2） [Срок оценки: 3 months]
• Progesterone（P） [Срок оценки: 3 months]
• Prolactin（PRL） [Срок оценки: 3 months]
• Testosterone（T） [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07142187 · TJ-IRB202508011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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