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The Effect of Sacral Surface Electrical Stimulation for Assisted Reproductive Technology (SSE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Shiga University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01082913
First Posted: March 9, 2010
Last Update Posted: March 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shiga University
  Purpose
The purpose of this study is to determine whether sacral surface electrical stimulation is effective in the treatment of assisted reproductive technology.

Condition Intervention Phase
Infertility Device: SSE Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Study of the Effect of Sacral Surface Electrical Stimulation for Assisted Reproductive Technology

Further study details as provided by Shiga University:

Primary Outcome Measures:
  • thickness of myometrium after embryo transfer [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • implantation rate [ Time Frame: 3 years ]

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sacral Surface Electrical (SSE) Device: SSE
Use of SSE or not use of SSE
No Intervention: control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of infertility
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082913


Locations
Japan
Shiga University of Medical Science Recruiting
Ohtsu, Shiga, Japan, 520-2192
Contact: Yoshihiko Shimizu, PhD    +81-77-548-2267    oshimi@belle.shiga-med.ac.jp   
Sponsors and Collaborators
Shiga University
  More Information

Responsible Party: Yoshihiko Shimizu, Shiga University of Medical Science
ClinicalTrials.gov Identifier: NCT01082913     History of Changes
Other Study ID Numbers: SSE
First Submitted: February 11, 2010
First Posted: March 9, 2010
Last Update Posted: March 9, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female