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

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

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.

Study Overview

• Status: Completed
• Conditions: IVF Treatment
• Intervention / Treatment: Device: Perform Echo at home.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • University Hospital VUB
  • Genk, Belgium, 3600
    • Hospital Oost-Limburg
  • Ghent, Belgium, 9000
    • Ghent University Hospital
  • Rocourt, Belgium, 4000
    • Clinique Saint-Vincent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Woman, suffering from subfertility.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: A home echo system will be used to perform an echo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Higher efficacy by taking an echo at home.	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.	Every 2 days, up to a year.

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Flanders Care
• Investigators: Principal Investigator: Jan Gerris, Ph.D, M.D., University Hospital, Ghent

Publications and helpful links

General Publications

• Gerris J, Delvigne A, Dhont N, Vandekerckhove F, Madoc B, Buyle M, Neyskens J, Deschepper E, De Bacquer D, Pil L, Annemans L, Verpoest W, De Sutter P. Self-operated endovaginal telemonitoring versus traditional monitoring of ovarian stimulation in assisted reproduction: an RCT. Hum Reprod. 2014 Sep;29(9):1941-8. doi: 10.1093/humrep/deu168. Epub 2014 Jul 3.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: January 21, 2013
• First Submitted That Met QC Criteria: January 29, 2013
• First Posted (Estimate): January 31, 2013

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2011/669