Acupuncture and Chinese Herbal Medicine to Improve Live Birth Rate of in Vitro Fertilization - A Randomized Controlled Trial (IVFAct)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,728
- 试验地点
- 12
- 主要终点
- Live birth
研究概览
简要总结
The most successful treatment for infertility is in vitro fertilization (IVF), but less than 10% of infertile couples undergo IVF because of the high cost and relatively low success rate. Many patients have tried complementary and alternative medical treatments as an adjuvant therapy to improve their IVF success. Acupuncture given 2-4 times around the day of embryo transfer has not been shown to improve the IVF live birth rate. Chinese Herbal Medicine (CHM) may improve the IVF pregnancy rates, but the evidence so far is inconclusive because of high risks of bias in these studies.
The objective of this multi-centre double blind randomized trial is to evaluate the efficacy of acupuncture with or without CHM on the live birth of IVF. The randomization process will be coordinated through a central mechanism. A total of 2,728 subjects will be randomized in 1:1:1:1 ratio in to one of the four treatment arms: 1) acupuncture and CHM, 2) acupuncture and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM. Women will receive acupuncture or control acupuncture three times a week 4 weeks prior to IVF during ovarian stimulation, and before and after the embryo transfer. They will also take CHM or placebo CHM daily 4 weeks prior to IVF till a negative pregnancy test or till 8 weeks of gestation if pregnant.
详细描述
The objective of this multi-centre double blind randomized trial is to evaluate the efficacy of acupuncture with or without CHM on the live birth of IVF. The randomization process will be coordinated through a central mechanism. A total of 2,728 subjects will be randomized in 1:1:1:1 ratio in to one of the four treatment arms: 1) acupuncture and CHM, 2) acupuncture and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM. Women will receive acupuncture or control acupuncture three times a week 4 weeks prior to IVF during ovarian stimulation, and before and after the embryo transfer. They will also take CHM or placebo CHM daily 4 weeks prior to IVF till a negative pregnancy test or till 8 weeks of gestation if pregnant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Women ≥20 to ≤40 years of age
- •Indications for IVF
- •Duration of infertility >1 year
- •Undergoing IVF with an intention of fresh ET on day 3 or 5.
排除标准
- •Women with an intention to replace frozen embryos only.
- •Preimplantation genetic testing
- •History of recurrent miscarriages defined as having three consecutive miscarriages.
- •Having acupuncture or CHM for infertility within 3 months prior the IVF
- •Women with abnormal liver or renal function tests
结局指标
主要结局
Live birth
时间窗: ≥20 weeks of gestation
Live birth defined as a delivery ≥20weeks gestation per transfer in the stimulated IVF cycles or in the first frozen-thawed embryo transfer cycle in those with elective freezing of all embryos
次要结局
- Embryo quality: embryo scoring standard(On the third day after egg retrieval and before embryo transfer)
- Multiple pregnancy rate(≥2 weeks after embryo transfer)
- Miscarriage rate(≤42 weeks of gestation)
- Ongoing pregnancy rate(≥8 weeks)
- Implantation rate(2 weeks after embryo transfer)
- Side effects(≤ 8 weeks of gestation)
- Pregnancy complications(≤42 weeks of gestation)
- Ectopic pregnancy rate(≥2 weeks after embryo transfer)
- Cumulative live birth rate(within 6 months after randomization)
- Positive serum human chorionic gonadotropin (hCG) level(2 weeks after embryo transfer)
- Health related quality of life(HRQoL)(≤8 weeks of gestation)
- Changes in markers of stress, anxiety(≤8 weeks of gestation)
- Congenital abnormalities(at 6 weeks postpartum)
- Patient acceptability: acupuncture trust score(On the day of embryo transfer)
研究者
Xiaoke Wu
Professor and Director of Obstetrics and Gynecology Department
Heilongjiang University of Chinese Medicine