Chinese Traditional Medicine Contribution to Improve In-vitro Fertilization (IVF) Results: Acupuncture in Embryo Transfer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 286
- 试验地点
- 2
- 主要终点
- Pregnancy rate
研究概览
简要总结
The aim of the study is to prove that acupuncture applied before and after embryo transfer is able to increase pregnancy rates by means of reducing stress and improving endometrial vascularization in women receiving in vitro Fertilization (IVF) treatments.
详细描述
Around 75% of all in vitro fertilization (IVF) treatments fail in providing a healthy baby at home. Most of the women undergoing those techniques suffer in some extent anxiety, depression and stress. Stress make IVF results worse and it has been prove by correlating cortisol, adrenaline and noradrenaline levels with failed cycles. Acupuncture has proved its ability to reduce stress levels. Moreover, Acupuncture has prove to have an effect inhibitory on the sympathetic system and this capacity improves vascularization in uterus and ovaries. Available literature concerning these two issues is not conclusive because of studies design. Acupuncture´s biological mechanism on controlled ovarian stimulation and embryo transfer has not been completely described; if it really has one. Published studies show very different designs and inconclusive/contradictory results can be withdrawn making very difficult to take the clinical decision of recommending acupuncture or not to in vitro fertilization (IVF) patients. If acupuncture really enhance pregnancy rates in IVF cycles still unanswered given that no randomized three arms study comparing no intervention to sham acupuncture to acupuncture has been published.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 to 37 years old
- •18-28 Body mass index (BMI)
- •Medical indication of intracytoplasmic sperm injection (ICSI) treatment to treat sterility
- •No previous in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatments
- •No previous experience of acupuncture treatments
- •At least one high quality embryo in the day of uterine transfer
排除标准
- •Polycystic ovarian syndrome
- •Endometriosis
- •Reproductive surgeries: any on uterus, fallopian tubes or ovaries
- •Ovarian cysts >20mm at the beginning of the stimulation cycle
- •Hormone treatment in the previous three months of the stimulation cycle, including oral contraceptives
- •Previous miscarriages and ectopic pregnancies
- •Oestradiol levels >3500pg/ml or ovarian size >65mm in human chorio gonadotropin (hCG) day.
- •Failure to keep confidentiality
- •Concomitant illness or severe adverse reaction
研究组 & 干预措施
SHAM ACUPUNCTURE
Sham intervention: acupuncture needle without puncture nor stimulation
干预措施: Acupuncture (Procedure)
REAL ACUPUNCTURE
Experimental: acupuncture in selected points of the protocol designed
干预措施: Acupuncture (Procedure)
Control
Bed Rest
干预措施: Bed Rest (Other)
结局指标
主要结局
Pregnancy rate
时间窗: 14 days after embryo transfer
Heart beating in intrauterus embryo
次要结局
- Rating preconceived ideas about acupuncture(From 24 hours (h) to 14 days after embryo transfer)
- Determination of serum prolactin and 24h urine cortisol.(The day of embryo transfer (+14 days post-cycle start)).)
- Endometrial vascularization study(The day of embryo transfer (+14 days after cycle start) and 2 days before and after it.)
- Analysis of the results of assisted reproductive cycle(After 14 days post-transfer (28 days after cycle star))