Effect of Acupuncture on Vascular Biomarkers and Psychological Well-Being of Women Undergoing In Vitro Fertilization (IVF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Urine prostacyclin before and after acupuncture
研究概览
简要总结
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.
详细描述
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:
- To measure urine prostacyclin and thromboxane, before and after acupuncture, and
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between ages 21-42 years seeking IVF.
- •Willing to undergo acupuncture
- •No contraindications to needle insertion.
排除标准
- •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.***
结局指标
主要结局
Urine prostacyclin before and after acupuncture
时间窗: Within 8-week course of IVF treatment
Measurement of the vasoactive molecule prostacyclin (pg/mg creatinine) in women undergoing IVF therapy.
Urine thromboxane before and after acupuncture
时间窗: Within 8-week course of IVF treatment
Measurement of the vasoactive molecule thromboxane (pg/mg creatinine) in women undergoing IVF therapy.
次要结局
未报告次要终点