Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women

Conditions
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FSH Hypersecretion, Endocrine System Diseases, Infertility

Intervention / Treatment
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* Other: CPA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CPA treatment<br>CPA treatment group receives 20 hours of patient centered manual physical therapy | Other: CPA<br>* Site specific, patient centered manual physical therapy regimen focused on restoring function to the entire body<br>* Other names: Wurn Technique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in endocrine levels post treatment | Change in FSH, LH and estradiol levels from baseline and pre-treatment, baseline and 30 and 60 day post treatment. | baseline, pre-treatment and 30 and 60 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain levels and sexual function before treatment | Pain levels and sexual function before treatment as compared to baseline. | 30 days before treatment | 
| Pain levels and sexual function post treatment | Pain levels and sexual function as measured by survey 30 days post treatment compared to baseline. | 30 days post treatment | 
| Pain levels and sexual function post treatment | Pain levels and sexual function as measured by survey 60 days post treatment compared to baseline. | 60 days post treatment | 
| Pregnancy | Subjects will be monitored for natural intrauterine pregnancy for the duration of the study. | study duration; 60 days post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infertility, elevated FSH, alternative treatment, Clear Passage Approach, Clear Passage Physical Therapy