Effect of Acupuncture on Vascular Biomarkers and Psychological Well-Being of Women Undergoing IVF

Hypothesis and Specific Aims The purpose of this pilot study is to determine if acupuncture affects the vasoactive molecules (prostacyclin and thromboxane) in women undergoing IVF therapy. The investigators' overall hypotheses for this area of study, to be addressed with future research, are: (1) acupuncture augments IVF success by enhancing the perfusion of pelvic organs including the ovaries and the uterus, and (2) acupuncture reduces the levels of stress and optimizes mind-body interaction in individuals undergoing IVF. Specific Aims: 1. To measure urine prostacyclin and thromboxane, before and after acupuncture, and 2. to assess the impacts of acupuncture on the psychological well-being of women undergoing IVF treatment. SIGNIFICANCE OF THE STUDY Results from this study will shed light on the mechanism by which acupuncture improves IVF outcomes. This may lead to other treatment strategies to improve success. Likewise, an established mechanism by which acupuncture improves IVF may lead to greater acceptance of this non-conventional treatment modality by the general population. Research Design and Methods This is a prospective, randomized, controlled study. Participants will be women in the Principal Investigator's practice seeking IVF. Participants will be randomized 1:1 into either the acupuncture group or the standard of care (no acupuncture) group. Each group will have 3 study visits. Rationale for the Control Group: A sham control group is not used because systematic review suggested that sham acupuncture controls may unnecessarily complicate the RCT evidence base given the nature of objective outcomes in IVF study (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3124624/). Power analysis With 35 patients allocated to each group, assuming the Student's T-test will be used to determine the differences between two independent samples, effect sizes d\>0.6 will be found statistically significant with alpha .05 and power .80. In practical terms, since the PSS validation samples showed a mean about 13.5 with variance=6.2, only averaged differences greater than 1.5 raw score points in PSS will be found statistically significant. The investigators plan to seek extramural funding in the future. The investigators will use the data obtained from this pilot study to perform power analysis and to calculate the number of participants needed in future proposals.