FSH HypersecretionNCT02027168
Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women
An observational study of FSH Hypersecretion and Endocrine System Diseases, run by Clear Passage Therapies, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- FSH Hypersecretion, Endocrine System Diseases, Infertility
- What is being tested?
- CPA
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with elevated FSH levels that undergo the CPA treatment
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clear Passage Physical Therapy
Gainesville, Florida, 32606
About this study
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.
Read the 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
- Conditions
- FSH Hypersecretion, Endocrine System Diseases, Infertility
- Being tested
- CPA
- Keywords
- infertility, elevated FSH, alternative treatment, Clear Passage Approach, Clear Passage Physical Therapy
- Medical subject headings
- Endocrine System Diseases, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAOther
Also called Clear Passage Approach, Wurn Technique
Site specific, patient centered manual physical therapy regimen focused on restoring function to the entire body
| Study group | Role | What they receive |
|---|---|---|
| CPA treatment | CPA treatment group receives 20 hours of patient centered manual physical therapy Receives: Other: CPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, pre-treatment and 30 and 60 days post treatment
Secondary outcomes (4)
Pain levels and sexual function before treatment
Pain levels and sexual function before treatment as compared to baseline.
Measured: 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.
Measured: 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.
Measured: 60 days post treatment
Pregnancy
Subjects will be monitored for natural intrauterine pregnancy for the duration of the study.
Measured: study duration; 60 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startFeb 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FSH HypersecretionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clear Passage Therapies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lawrence J Wurn, LMT, Principal investigator, Clear Passage Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027168
- Sponsor's protocol ID
- FSH-2012-001
- Status last verified
- Jan 2015
- First submitted
- 2 Jan 2014
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wurn BF, Wurn LJ, King CR, Heuer MA, Roscow AS, Hornberger K, Scharf ES. Treating fallopian tube occlusion with a manual pelvic physical therapy. Altern Ther Health Med. 2008 Jan-Feb;14(1):18-23.
PubMed 18251317Wurn LJ, Wurn BF, King CR, Roscow AS, Scharf ES, Shuster JJ. Increasing orgasm and decreasing dyspareunia by a manual physical therapy technique. MedGenMed. 2004 Dec 14;6(4):47.
PubMed 15775874Wurn BF, Wurn LJ, King CR, Heuer MA, Roscow AS, Scharf ES, Shuster JJ. Treating female infertility and improving IVF pregnancy rates with a manual physical therapy technique. MedGenMed. 2004 Jun 18;6(2):51.
PubMed 15266276
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women
- ClinicalTrials.gov ID
- NCT02027168
- Acronym / sponsor ID
- FSH-2012-001
- Conditions
- FSH Hypersecretion, Endocrine System Diseases, Infertility
- Keywords
- infertility, elevated FSH, alternative treatment, Clear Passage Approach, Clear Passage Physical Therapy
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Clear Passage Therapies, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPA treatment | – | Other: CPACPA treatment group receives 20 hours of patient centered manual physical therapy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with elevated FSH levels that undergo the CPA treatment
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Active infection including HIV or inflammation
- Cancer within the past 5 years
- Currently pregnant
- Hemophilia, abnormal bleeding or clotting disorder
- Immune system disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAAlso: Clear Passage Approach, Wurn TechniqueSite specific, patient centered manual physical therapy regimen focused on restoring function to the entire body | Other | CPA treatment |
Primary outcome
Change in endocrine levels post treatment
Time frame: 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.
4 secondary outcomes
Pain levels and sexual function before treatment
Time frame: 30 days before treatment
Pain levels and sexual function post treatment
Time frame: 30 days post treatment
Pain levels and sexual function post treatment
Time frame: 60 days post treatment
Pregnancy
Time frame: study duration; 60 days post treatment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Background: PubMed 18251317Wurn BF, Wurn LJ, King CR, Heuer MA, Roscow AS, Hornberger K, Scharf ES. Treating fallopian tube occlusion with a manual pelvic physical therapy. Altern Ther Health Med. 2008 Jan-Feb;14(1):18-23.
- Background: PubMed 15775874Wurn LJ, Wurn BF, King CR, Roscow AS, Scharf ES, Shuster JJ. Increasing orgasm and decreasing dyspareunia by a manual physical therapy technique. MedGenMed. 2004 Dec 14;6(4):47.
- Background: PubMed 15266276Wurn BF, Wurn LJ, King CR, Heuer MA, Roscow AS, Scharf ES, Shuster JJ. Treating female infertility and improving IVF pregnancy rates with a manual physical therapy technique. MedGenMed. 2004 Jun 18;6(2):51.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence J Wurn, LMT principal investigator
Clear Passage Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of FSH Hypersecretion and Endocrine System Diseases, run by Clear Passage Therapies, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endocrine levels post treatment (time frame: baseline, pre-treatment and 30 and 60 days post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02027168, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015.