A Randomized Controlled Study on the Short-term Intervention of Acupuncture in the Freeze-all IVF Cycle to Improve Pregnancy Rate
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate (%)
研究概览
简要总结
In the early stage, our team found that Acupuncture intervention in freeze-all IVF cycles can improve the clinical pregnancy rate. In order to further study the role of Acupuncture in improving the pregnancy outcome of IVF-ET in infertility. A randomized controlled clinical trial will be used in this study. 90 infertile patients are randomly divided into two groups. The control group will be treated with conventional modern medicine, and the treatment group will be treated with Acupuncture on the basis of conventional modern medicine. The intervention starts from the 5th day of the menstrual cycle and lasts to the day before IVF-ET. The number of oocytes, antral follicles, AMH, serum FSH, and clinical pregnancy rate will be observed to evaluate the effect of Acupuncture on the improvement of pregnancy outcome. In addition, all of the participants will be asked to complete the self-evaluation of the anxiety/depression scale on the 7th day of the menstrual cycle, before and after transplantation, to analyze the emotional changes of the subjects during the study. We observe the safety and health economic indicators of Acupuncture treatment, so as to improve the overall efficacy of TCM Combined Application in assisted reproductive technology in the future.
详细描述
The study will be conducted on patients with DOR attending our reproductive medicine center for proposed IVF-ET between June 2021and December 2022.
The trial is designed as a randomized, controlled clinical trial with two groups established by 1:1 equal allocation, a treatment group with interventions using acupuncture to tonify the kidneys and regulate blood and a control group treated using conventional Western medicine.
Random numbers will be prepared by an independent third-party statistician who prepared a list of random group codes for this study. Enrolled subjects will be given a subject number during the screening process and, upon formal enrolment, will be randomly assigned to either the test or control group with a corresponding random number.
The acupoints used will be:
Zhongwan (RN12) ：The needle should be punctured for 1-1.2 inches and retained for 30 minutes.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for infertility.
- •Meet the criteria for identifying kidney deficiency in TCM.
- •Patients who Planning to undergo IVF-ET for pregnancy in our center, Age ≤40 years and ≥25 years.
- •Previous embryo transfer failure ≥ 2 times.
- •Menstrual cycle is basically normal, and normal ovulation has been monitored in the past.
- •There were more than 1 blastocyst /more than 2 high-quality embryos with more than 6 cells on day 3/more than 2 high-quality embryos with more than 4 cells on day
- •Consent to participate in this clinical trial and sign an informed consent form.
排除标准
- •Patients with endometritis, acute pelvic inflammatory disease, mycotic vaginitis, bacterial vaginitis, adnexitis or other systemic infections.
- •It has been confirmed that there are obvious and serious other organic lesions in the reproductive organs.
- •Patients with allergic constitution
- •Infertility caused by genetic factors
- •Patients with serious primary diseases such as cardio cerebrovascular, kidney, liver and hematopoietic system and psychosis
- •A person who is unable to cooperate (such as a combination of neurological or mental illness, or a reluctance to cooperate)
- •The endometrial thickness on the day of hCG was less than 6 mm or the endometrial morphology on the day of hCG was type C
- •Those who did not agree to participate in the study
研究组 & 干预措施
Acupuncture treatment group
Method: Acupuncture at Zhongwan、Qihai、Guanyuan、Zhongji、Guilai、Shenshu、Ciliao、Xuehai、Sanyinjiao、Taixi. The acupuncture treatment starts on the 5th day of the menstrual cycle and lasts to the days before IVF-ET
干预措施: Acupuncture (Other)
Western medicine group
The western medicine group will be treated with conventional western medicine
干预措施: Western medicine (Other)
结局指标
主要结局
Clinical pregnancy rate (%)
时间窗: up to 6 weeks from enrollment
Follow up by telephone calls 14days after the IVF-ET
次要结局
- Concentration of β-human Choriogonadotropin(β-HCG)(up to 6 weeks from enrollment)