FSH Hypersecretion, Endocrine System Diseases, Infertility
Conditions
Keywords
infertility, elevated FSH, alternative treatment, Clear Passage Approach, Clear Passage Physical Therapy
Brief summary
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
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
Interventions
OTHERCPA
Site specific, patient centered manual physical therapy regimen focused on restoring function to the entire body
Sponsors
Clear Passage Therapies, Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in endocrine levels post treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain levels and sexual function before treatment | 30 days before treatment | Pain levels and sexual function before treatment as compared to baseline. |
| Pain levels and sexual function post treatment | 30 days post treatment | Pain levels and sexual function as measured by survey 30 days post treatment compared to baseline. |
| Pregnancy | study duration; 60 days post treatment | Subjects will be monitored for natural intrauterine pregnancy for the duration of the study. |
Countries
United States
Outcome results
None listed