Effect of Acupuncture on Vascular Biomarkers and Psychological Well-Being of Women Undergoing IVF
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Experimental Approach: (1) Participants: Women (ages 21 to 42) who seek IVF treatment at the
      Center for Fertility & Reproductive Surgery will be eligible for the study. Seventy women
      will be recruited and randomly assigned to either the intervention (acupuncture plus standard
      care) or the comparison (standard care alone) group. (2) Intervention: Participants in the
      intervention group will receive 3 acupuncture sessions during the project with the first
      treatment between day 6-8 of the stimulated IVF cycle, second on the day of embryo transfer
      and the third one day post transfer. Participants in the comparison group will receive no
      intervention but will receive standard care. (3) Measures: The primary outcome measures
      include prostacyclin and thromboxane vasoactive biomarkers. Secondary outcome measures
      include perceived stress levels. (4) Procedure: Upon IRB approval, an informed consent will
      be provided to all participants. Pre- and post- acupuncture urinary metabolites of
      prostacyclin and thromboxane will be assessed. A standardized Perceived Stress Scale will be
      administered before and after each acupuncture session for the study group, and before and
      after a 30-40-minute waiting period for the control group.
    

Detailed description: 
      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.
    

Intervention name(s): Acupuncture
Intervention type(s): Procedure
Intervention description(s): Participants will receive 3 acupuncture sessions during IVF process
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science