The Effect of Sacral Surface Electrical Stimulation for Assisted Reproductive Technology (SSE)
Primary Purpose
Infertility
Status
Unknown status
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
SSE
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of infertility
Sites / Locations
- Shiga University of Medical ScienceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sacral Surface Electrical (SSE)
control
Arm Description
Outcomes
Primary Outcome Measures
thickness of myometrium after embryo transfer
Secondary Outcome Measures
implantation rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01082913
Brief Title
The Effect of Sacral Surface Electrical Stimulation for Assisted Reproductive Technology
Acronym
SSE
Official Title
Study of the Effect of Sacral Surface Electrical Stimulation for Assisted Reproductive Technology
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Shiga University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether sacral surface electrical stimulation is effective in the treatment of assisted reproductive technology.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sacral Surface Electrical (SSE)
Arm Type
Experimental
Arm Title
control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
SSE
Intervention Description
Use of SSE or not use of SSE
Primary Outcome Measure Information:
Title
thickness of myometrium after embryo transfer
Time Frame
3 years
Secondary Outcome Measure Information:
Title
implantation rate
Time Frame
3 years
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of infertility
Facility Information:
Facility Name
Shiga University of Medical Science
City
Ohtsu
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshihiko Shimizu, PhD
Phone
+81-77-548-2267
Email
oshimi@belle.shiga-med.ac.jp
12. IPD Sharing Statement
Learn more about this trial
The Effect of Sacral Surface Electrical Stimulation for Assisted Reproductive Technology
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