Acupuncture/Reproductive Hormones/Ovulation/Polycystic

描述（由申请人提供）：多囊卵巢疾病（PCOS）是育龄妇女中最常见的内分泌疾病，也是周期不规则和无排卵性不孕症的最常见原因。针灸可能是这些妇女激素治疗的替代方案，基于三项研究，少于50名针灸受试者和无对照组的阳性结果。这些研究中最好的一项检查了24名PCOS妇女，发现38%的妇女在治疗加随访期间恢复了排卵（2+排卵）。这项研究将是一项双盲、安慰剂对照、随机临床试验，以评估针灸是否能恢复PCOS患者的排卵（2+排卵）并使卵巢激素正常化。参与者（n=78名完成者）将随机接受针灸治疗或假手术（Park Sham器械），持续标准的8周时间。所有参与者将在治疗前、治疗后和三个月后通过弗吉尼亚大学综合临床研究中心提供血液样本，从中检测生殖激素、雄激素和胰岛素/葡萄糖。在整个治疗和随访期间，将每周提供一次尿液样本，以确定是否发生排卵。为了收集潜在混杂因素的数据，将测量体重，并在与血样相同的三个时间段进行问卷调查。将结合比值比、多元logistic回归、重复测量分析、广义估计方程和协方差分析对结果进行分析。与现有文献相比，本研究将是一个明显的增强，包括假治疗对照组，PCOS的严格诊断，以及收集月经周期的血液样本（适用于排卵周期）。这项研究将评估在我们的PCOS人群中，针灸是否增加排卵频率，导致卵泡刺激素（FSH）与黄体生成素（LH）的比例正常化，并导致FSH和LH的平均水平向正常水平调整（分别增加和减少）。在未来的研究中，还将进行探索性分析，以估计一些患者群体（例如，正常的胰岛素，较小的体重指数）对针灸治疗更有反应。我们还将比较针灸临床试验中基于人群招募女性的招募策略。

DESCRIPTION (provided by applicant): Polycystic Ovary Disease (PCOS) is the most common endocrine disorder among reproductive age women, and is the most common cause of irregular cycles and anovulatory infertility. Acupuncture may represent an alternative to hormonal treatment for these women, based on three studies with positive findings with fewer than 50 acupuncture subjects and no control group. The best of these studies examined 24 PCOS women and found that 38% of the women had restored ovulation (2+ ovulations) during the treatment plus follow-up time period. The proposed research will be a double-blind, placebo-controlled, randomized clinical trial to assess if acupuncture restores ovulation (2+ ovulations) and normalizes ovarian hormones in women v/ith PCOS. Participants (n=78 completers) will be randomized to receive either acupuncture treatment or a sham procedure (Park Sham Device) for a standard 8-week period of time. All participants will provide blood samples through the University of Virginia General Clinical Research Center before treatment, after treatment, and three months later from which reproductive hormones, androgens and insulin/glucose will be assayed. Urine samples will be provided weekly throughout the treatment and follow-up periods to determine if ovulation has occurred. To collect data on potential confounders, weight will be measured and questionnaires administered at the same three time periods as the blood samples. Results will be analyzed with a combination of odds ratios, multiple logistic regression, repeated measures analyses, generalized estimating equations, and analysis of covariance. This study will be a clear enhancement compared to the existing literature by inclusion of a sham treatment control group, rigorous diagnosis of PCOS, and collection of blood samples timed to the menstrual cycle (applicable when there is an ovulatory cycle). This research will assess within our PCOS population whether acupuncture increases ovulatory frequency, causes the ratio of follicle simulating hormone (FSH) to luteinizing hormone (LH) to normalize, and causes the mean levels of FSH and LH to adjust towards normal levels (increase and decrease, respectively). Toward future research, an exploratory analysis will also be conducted to estimate if some patient groups (e.g., normal insulin, smaller body mass index) are more responsive to acupuncture therapy. We will also compare enrollment strategies for population-based recruitment of women into an acupuncture clinical trial.