Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in endocrine levels post treatment
研究概览
简要总结
This study will examine the impact of manual physical therapy on endocrine function in women diagnosed as being infertile due to elevated follicle stimulating hormone (FSH) levels (10 mIU/mL or higher) on days 2-5 of their menstrual cycle. It is hypothesized that the manual physical therapy will decrease FSH levels.
详细描述
This study will investigate the effect of manual physical therapy on the endocrine levels of women by comparison of pre- and post- treatment hormone levels (FSH, LH and Estradiol). Secondary measures include assessment of pain and sexual function via questionnaires.
Hormones will be measured at prescribed time points:
- baseline: 30-60 days before treatment
- pre-treatment: 7-30 days before treatment
- post treatment 1: 10-30 days post treatment
- post treatment 2: 30-60 days post treatment
Pain and sexual function questionnaires will be completed:
- baseline: 30-60 days before treatment
- pre-treatment: 7-30 days before treatment
- post treatment 1: 30 days post treatment
- post treatment 2: 60 days post treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as infertile
- •FSH greater than 10mIU/mL on days 2-5 of menstrual cycle
- •Regular menstrual cycle
- •Residing in the US, accessible to a LabCorp testing facility
排除标准
- •Active infection including HIV or inflammation
- •Cancer within the past 5 years
- •Currently pregnant
- •Hemophilia, abnormal bleeding or clotting disorder
- •Immune system disorder
- •Abnormal ovarian cyst or endometrioma
- •BMI of 35 or greater
- •Any other condition in which deep manual physical therapy is contraindicated
- •Currently taking any fertility medications or planning to take any fertility related medications during the course of the study. This includes all ovarian stimulating medications, artificial hormones and birth control medications.
- •Participation in any assisted reproductive technique (such as IVF) other than intra-uterine insemination during the course of the study.
结局指标
主要结局
Change in endocrine levels post treatment
时间窗: baseline, pre-treatment and 30 and 60 days post treatment
Change in FSH, LH and estradiol levels from baseline and pre-treatment, baseline and 30 and 60 day post treatment.
次要结局
- Pain levels and sexual function before treatment(30 days before treatment)
- Pain levels and sexual function post treatment(60 days post treatment)
- Pregnancy(study duration; 60 days post treatment)