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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
Flanders Care
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01781143
First received: January 21, 2013
Last updated: January 29, 2013
Last verified: January 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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. ] [ Designated as safety issue: No ]
    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 2013
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman, suffering from subfertility.
  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: 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. Ghent University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01781143     History of Changes
Other Study ID Numbers: 2011/669
Study First Received: January 21, 2013
Last Updated: January 29, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Menthol
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014