The Effect of Electro-thumbtack Needle on Live Birth Rate in Patients With Ovarian Reserve Dysfunction (DOR): a Multicenter Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 368
- 主要终点
- live birth rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
live birth rate
时间窗: 3 months
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.
live birth rate
时间窗: 3 months
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.
次要结局
- estradiol（E2）(3 months)
- 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)
- Antral Follicle Count (AFC)(3 months)
- follicle stimulating hormone（FSH）(3 months)
- Luteinizing hormone (LH)(3 months)
- Progesterone（P）(3 months)
- Prolactin（PRL）(3 months)
- Testosterone（T）(3 months)
- ZungSelf-RatingAnxietyScale（Zung-SAS）(3 months)
- Zung Self-rating depression scale(Zung-SDS)(3 months)
- Short form-36（SF-36）(3 months)
- Chinese Quality of Life Scale (CHQOL)(3 months)
- Self Rating Sleep Scale (SRSS)(3 months)
- The Sleep Disorders Rating Scale (SDRS)(3 months)
- Pittsburgh Sleep Quality Index (PSQI)(3 months)
- corticotropin releasing hormone (CRH)(3 months)
- norepinephrine(3 month)
- epinephrine(3 months)
- 5-hydroxytryptamine (5-HT)(3 months)
- gamma aminobutyric acid (GABA)(3 months)
- dopamine (DA)(3 months)
- beta endorphin (β - ET)(3 months)
- 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)
- Antral Follicle Count (AFC)(3 months)
- follicle stimulating hormone（FSH）(3 months)
- Luteinizing hormone (LH)(3 months)
- estradiol（E2）(3 months)
- Progesterone（P）(3 months)
- Prolactin（PRL）(3 months)
- Testosterone（T）(3 months)
- ZungSelf-RatingAnxietyScale（Zung-SAS）(3 months)
- Zung Self-rating depression scale(Zung-SDS)(3 months)
- Self Rating Sleep Scale (SRSS)(3 months)
- corticotropin releasing hormone (CRH)(3 months)
- norepinephrine(3 month)
- epinephrine(3 months)
- dopamine (DA)(3 months)
- Short form-36（SF-36）(3 months)
- The Sleep Disorders Rating Scale (SDRS)(3 months)
- Pittsburgh Sleep Quality Index (PSQI)(3 months)
- Chinese Quality of Life Scale (CHQOL)(3 months)
- 5-hydroxytryptamine (5-HT)(3 months)
- gamma aminobutyric acid (GABA)(3 months)
- beta endorphin (β - ET)(3 months)
研究者
Dongmei Huang
Clinical Professor of Integrated Traditional Chinese and Western Medicine at Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Tongji Hospital