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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)

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 June 2015 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01781143
First Posted: January 31, 2013
Last Update Posted: June 3, 2015
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.
Collaborator:
Flanders Care
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose
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 Intervention
IVF Treatment Device: Perform Echo at home.

Study Type: Interventional
Study Design: 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).

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
  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): 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
  More Information

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 Submitted: January 21, 2013
First Posted: January 31, 2013
Last Update Posted: June 3, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Menthol
Antipruritics
Dermatologic Agents