Effects of Acupuncture on Ovarian Reserve Function and Pregnancy Outcomes in Women With Decreased Ovarian Reserve: a Multicenter Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- AFC
研究概览
简要总结
The randomized, placebo-controlled multicenter trial is conducted in three centers in China. After screening and obtaining the signed informed consent, the participants are randomly divided into two groups: acupuncture group and sham acupuncture group.
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
- •1. Infertile women older than 18 years and younger than 40 years to undergo fresh IVF or self-pregnant;
- •2. AMH\<1.1 ng/ml；
- •3. total AFC\< 7；
- •4. 10 U/L\2.6；
- •5. had a history of low ovarian response once, and the number of eggs obtained in IVF was less than 3 （at least two of the 2）3）4）5 ）items are required）；
- •6. Willing to accept randomized grouping, treatment arrangement and follow-up, and signing informed consent.
排除标准
- •Patients who met any of the following conditions were not included:
- •Severe abnormality of uterine cavity caused by adenomyosis, uterine fibroids, endometrial polyps, tuberculosis of the reproductive system, endometritis, abnormal endometrial thickness (HCG day of the previous IVF cycle is less than 7mm or greater than 14mm);
- •Patients with other endocrine diseases, such as thyroid disease, hyperprolactinemia, insulin resistance, diabetes, adrenal disease, etc., and poor control of hormone levels in the last 3 months;
- •Clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, etc.;
- •Untreated hydrosalpinx;
- •Body mass index (BMI) higher than 28 kg/m;
- •The male or female chromosome abnormality;
- •People with previous history of acupuncture sickness;
- •Those who have previously participated in the study or are currently receiving acupuncture treatment.
研究组 & 干预措施
Acupuncture group
Acupuncture was performed 2-3 times a week for 30 minutes each time for 3 months, starting from the 5th day of menstruation (spontaneous menstruation or drug withdrawal hemorrhaging menstruation)
干预措施: acupuncture (Device)
Sham acupuncture group
Sham acupuncture was performed 2-3 times a week for 30 minutes each time for 3 months, starting from the 5th day of menstruation (spontaneous menstruation or drug withdrawal hemorrhaging menstruation)
干预措施: Sham acupuncture (Device)
结局指标
主要结局
AFC
时间窗: on the 3rd day of menstruation
Antral follicle count
次要结局
- Blood levels of FSH, LH, E2 and AMH on the 3rd day of menstruation(on the 3rd day of menstruation)
- β-HCG positive pregnancy rate(Two weeks after ET or when menstruation expired for natural pregnancy)
- Clinical pregnancy rate(4 weeks after ET or natural pregnancy: B ultrasonography was used to observe whether there were pregnant sac and cardiac tube pulsation in uterine cavity)
- Live birth rate(Gestation greater than 24 weeks and birth as a live fetus)
研究者
Cui Hong Zheng
Associate professor
Huazhong University of Science and Technology