NCT01082913

Brief Summary

The purpose of this study is to determine whether sacral surface electrical stimulation is effective in the treatment of assisted reproductive technology.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2010

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 9, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 9, 2010

Status Verified

January 1, 2010

Enrollment Period

2.9 years

First QC Date

February 11, 2010

Last Update Submit

March 8, 2010

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • thickness of myometrium after embryo transfer

    3 years

Secondary Outcomes (1)

  • implantation rate

    3 years

Study Arms (2)

Sacral Surface Electrical (SSE)

EXPERIMENTAL
Device: SSE

control

NO INTERVENTION

Interventions

SSEDEVICE

Use of SSE or not use of SSE

Sacral Surface Electrical (SSE)

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiga University of Medical Science

Ohtsu, Shiga, 520-2192, Japan

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2010

First Posted

March 9, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 9, 2010

Record last verified: 2010-01

Locations

JP(1)