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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
Shiga University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

First Posted
February 11, 2010
Last Updated
March 8, 2010
Sponsor
Shiga University
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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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