NCT02027168

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

1.9 years

First QC Date

January 2, 2014

Last Update Submit

January 22, 2015

Conditions

FSH HypersecretionEndocrine System DiseasesInfertility

Keywords

infertilityelevated FSHalternative treatmentClear Passage ApproachClear Passage Physical Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Pain levels and sexual function before treatment

    30 days before treatment

  • Pain levels and sexual function post treatment

    30 days post treatment

  • Pain levels and sexual function post treatment

    60 days post treatment

  • Pregnancy

    study duration; 60 days post treatment

Study Arms (1)

CPA treatment

CPA treatment group receives 20 hours of patient centered manual physical therapy

Other: CPA

Interventions

CPAOTHER

Site specific, patient centered manual physical therapy regimen focused on restoring function to the entire body

Also known as: Clear Passage Approach, Wurn Technique
CPA treatment

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women with elevated FSH levels that undergo the CPA treatment

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clear Passage Physical Therapy

Gainesville, Florida, 32606, United States

Location

Related Publications (3)

  • 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.

    PMID: 18251317BACKGROUND

  • Wurn 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.

    PMID: 15775874BACKGROUND

  • Wurn 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.

    PMID: 15266276BACKGROUND

MeSH Terms

Conditions

Endocrine System DiseasesInfertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Lawrence J Wurn, LMT

    Clear Passage Physical Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 6, 2014

Study Start

February 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations

US(1)