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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Shiga University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shiga University
ClinicalTrials.gov Identifier:
NCT01082913
First received: February 11, 2010
Last updated: March 8, 2010
Last verified: January 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Study of the Effect of Sacral Surface Electrical Stimulation for Assisted Reproductive Technology

Resource links provided by NLM:


Further study details as provided by Shiga University:

Primary Outcome Measures:
  • thickness of myometrium after embryo transfer [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • implantation rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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
Other Name: SSE
No Intervention: control

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of infertility
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Yoshihiko Shimizu, Shiga University of Medical Science
ClinicalTrials.gov Identifier: NCT01082913     History of Changes
Other Study ID Numbers: SSE
Study First Received: February 11, 2010
Last Updated: March 8, 2010
Health Authority: Japan: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014