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.
Verified January 2013 by University Hospital, Ghent
Sponsor:
University Hospital, Ghent
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
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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
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 May 16, 2013