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Self-operated Endo-vaginal Telemonitoring (SOET), an Economic and Patient-empowered Method for Ovarian Stimulation for In-vitro Fertilization (IVF) (SOET)

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ClinicalTrials.gov Identifier: NCT01781143
Recruitment Status : Unknown
Verified June 2015 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : January 31, 2013
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
Flanders Care
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
The SOET project introduces a new strategy for routine follow-up of follicle growth during the hormonal treatment phase of an in-vitro fertilization (IVF) treatment cycle. After a learning instruction and demo, patients should be able to perform most of their vaginal echoes at home. The images can be sent to the medical center over the internet. These images are analyzed by the expert.

Condition or disease Intervention/treatment Phase
IVF Treatment Device: Perform Echo at home. Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Self-operated Endo-vaginal Telemonitoring (SOET), an Economic and Patient-empowered Method for Ovarian Stimulation for In-vitro Fertilization (IVF).
Study Start Date : January 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Perform echo at home.
A group of women that follows an IVF treatment, will perform their echoes at home, instead of always make an appointment in the clinic.
Device: Perform Echo at home.
A group of women that follows an IVF treatment, will perform their echoes at home, instead of always make an appointment in the clinic.
Other Name: A home echo system will be used to perform an echo.



Primary Outcome Measures :
  1. Higher efficacy by taking an echo at home. [ Time Frame: Every 2 days, up to a year. ]
    During an IVF treatment, women are asked to perform the echo themselves, at home. This should create higher efficacy: patients are less stressed and can choose the moment of taking the echo themselves. Furthermore, this should result in a more cost effective and time saving way.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman, suffering from subfertility.

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): NCT01781143


Contacts
Contact: Jan Gerris, Ph.D, M.D. Jan.Gerris@ugent.be

Locations
Belgium
University Hospital VUB Recruiting
Brussels, Belgium, 1000
Contact: Willem Verpoest, M.D.       Willem.Verpoest@uzvub.be   
Principal Investigator: Willem Verpoest, M.D.         
Hospital Oost-Limburg Recruiting
Genk, Belgium, 3600
Contact: Willem Ombelet, M.D.       Willem.Ombelet@pandora.be   
Principal Investigator: Willem Ombelet, M.D.         
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Jan Gerris, Ph.D, M.D.       Jan.Gerris@ugent.be   
Principal Investigator: Jan Gerris, Ph.D., M.D.         
Clinique Saint-Vincent Recruiting
Rocourt, Belgium, 4000
Contact: Annick Delvigne, M.D.       Annick.Delvigne@chc.be   
Principal Investigator: Annick Delvigne, M.D.         
Sponsors and Collaborators
University Hospital, Ghent
Flanders Care
Investigators
Principal Investigator: Jan Gerris, Ph.D, M.D. University Hospital, Ghent

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01781143     History of Changes
Other Study ID Numbers: 2011/669
First Posted: January 31, 2013    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Menthol
Antipruritics
Dermatologic Agents