Acupuncture for Infertility Patients: The Effect on IVF
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
Infertility is a common problem with increased incidence. In-vitro fertilization (IVF) is by far the most commonly used treatment. The success rate of IVF is still low. This study examines the effect of acupuncture on IVF pregnancy rate, as well as possible mechanisms. It is hypothesized that acupuncture can significantly increase the IVF pregnancy rate.
详细描述
Infertility is a common health problem in the United States with approximately 15% of women of childbearing age receiving care for this disorder. One of the most successful and commonly utilized treatment options is in-vitro fertilization (IVF). Data collected by the Center for Disease Control (CDC) and the Society for Assisted Reproduction (SART) showed that in the year 2001, over 100,000 IVF treatment cycles were performed through the more than 400 IVF centers in the U.S. Despite many recent technological advances, pregnancy rates with IVF remain limited with the most recent CDC/SART data reporting that only 27% of treatment cycles result in a live birth. Acupuncture has been utilized in China for centuries to regulate the female reproductive system and has in recent years become a popular option for infertile couples in the States. Though acupuncture has been studied in other infertility settings, IVF is chosen because:
- IVF is one of the most common infertility treatments as well as the most resource intensive treatment option. Therefore, an improvement in IVF success will provide the greatest benefit to patients and society.
- IVF affords a unique opportunity to gather the most data regarding the reproductive process and to investigate putative acupuncture related physiological changes.
We propose a randomized, sham controlled feasibility study on the effect of acupuncture on IVF. Sixty IVF patients will be recruited into the study to accomplish the following aims:
- To examine the feasibility of recruiting and retaining a sufficient number of patients for an adequate powered study,
- To identify issues related to the multicenter approach that could alter study endpoints,
- To examine the effect size of the treatment group as compared to the sham group,
- To examine whether acupuncture is a safe procedure for women undergoing IVF,
- To examine the effect of acupuncture on clinical IVF outcomes, and
- To examine the physiological and psychological impact of acupuncture on IVF patients.
Results obtained from the study will provide necessary information for a larger, definitive study, as well as knowledge regarding the broad mechanism of acupuncture on female reproductive function.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient is undergoing in-vitro fertilization protocol (both IVF and intracytoplasmic sperm injection - ICSI)
- •Patient is acupuncture naïve.
- •Patient has basal serum follicle-stimulating hormone (FSH) < 10
- •Patient has given informed consent to participate in study
排除标准
- •Patient has had acupuncture performed previously or currently
- •Patient has basal serum FSH of 10 or more
结局指标
主要结局
Clinical pregnancy rate
时间窗: 6 to 8 weeks
次要结局
- Miscarriage rate(one year)
- Take home baby rate(one year)
- B-endorphin levels(2 weeks)
- Stress measurement(4 weeks)
研究者
Grant G. Zhang
Assistant Professor
National Center for Complementary and Integrative Health (NCCIH)