Effect of Acupuncture on Vascular Biomarkers and Psychological Well-Being of Women Undergoing IVF
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Women's Studies, Infertility |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 21 - 42 |
| Updated: | 4/26/2018 |
| Start Date: | November 2015 |
| End Date: | December 2018 |
Effect of Acupuncture on Vascular Biomarkers and Psychological Well-Being of Women Undergoing In Vitro Fertilization (IVF)
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.
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.
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.
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.
Inclusion Criteria:
- Women between ages 21-42 years seeking IVF.
- Willing to undergo acupuncture
- No contraindications to needle insertion.
Exclusion Criteria:
- Women currently using alternative therapies such as acupressure, herbal supplements
and meditation techniques.
- Women with generalized psoriasis, neuropathy or coagulopathies posing increased risk
due to needle insertion.
- Women with previous experience with acupuncture.
***Please note that we are unable to give a discount on IVF cost for participating in the
study.***
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