The Clinical Trial of the Effect of Transcutaneous Electrical Acupoint Stimulation on the Quality of the Oocyte on Poor Ovarian Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- The number of MII eggs
研究概览
简要总结
Patients in experimental group will be given transcutaneous electrical acupoint stimulation (TEAS) treatment for 12 weeks prior to controlled ovarian stimulation (COS).The patients will be given three times acupuncture every week except menstruation.Patients in no intervention group will not be given any interventions for 12 weeks prior to COS. The primary outcome measure is the number of MII eggs obtained in the COS cycle. The secondary outcome measures are the lab and clinical reproductive outcomes.
详细描述
The patients will be randomly recruited into two groups. Patients in experimental group will be given TEAS treatment for 12 weeks prior to COS.The patients will be given three times acupuncture every week except menstruation. One treatment lasts for 30 minutes. The acupoints used for the TEAS treatment included head acupoint Baihui(DU20), abdominal acupoint Zhongji (RN3), Guanyuan (RN4), Zigong(EX-CA1), leg acupoint Sanyinjiao(SP6), waist acupoint Shenyu (BL23) and Guanyuanyu(BL26). Patients in no intervention group will not be given any intervention for 12 weeks prior to COS. When at least one dominant follicle is greater than 18 mm then injection a GnRH agonist (Triptorelin, Ferring, Switzerland) 0.2mg. 36 hours later transvaginal oocyte retrieval will be taken. After 3 hours of incubation, each egg will be transferred with a density of about 100,000/mllive sperm. The fresh embryo transfer is performed 72 hours after embryo culture in vitro. The whole embryos will be frozen.
The primary outcome measure is the number of MII eggs obtained in the COS cycle. The secondary outcome measures are the lab and clinical reproductive outcomes,including basic endocrine, serum Anti-Mullerian Hormone （AMH）, antral follicle counts, fertilization rate, cleavage rate, number of D3 embryos, the clinical pregnancy rate and early abortion rate.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The poor ovarian response patients compliance with Bologna consensus
- •Age：20-45 year
- •Women undergoing IVF-ET because of infertility for more than one year.
排除标准
- •Patients with genital tract malformation. Uterine malformation (single uterus, double uterus, double uterus, untreated mediastinal uterus) and other effects affecting uterine cavity disease (adenomyosis, submucosal uterine fibroids, intrauterine adhesions and scar uterus)
- •Complicated with other medical diseases（Hypertension, diabetes, psychosis, hereditary diseases）
结局指标
主要结局
The number of MII eggs
时间窗: one day after oocyte pickup
The number of MII eggs obtained in the COS cycle
次要结局
- Basic Follicle stimulating hormone （FSH） value(On Day two of menstruation)
- cleavage rate(cleavage rate calculated on 2 days after oocyte pickup)
- the number of Day 3 embryos(the number of Day 3 embryos calculated on 3 days after oocyte pickup)
- clinical pregnancy rate(clinical pregnancy rate calculated on the 6th gestational week)
- antral follicle count(antral follicle count On Day two of menstruation)
- fertilization rate(fertilization rate calculated on 1 day after oocyte pickup)
- early abortion rate(early abortion rate calculated on 12th week of pregnancy)
- Basic estrodiol value(On Day two of menstruation)
- Serum AMH value(On Day two of menstruation)
- Basic Luteinizing hormone （LH） value(On Day two of menstruation)