NCT01781143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

5.4 years

First QC Date

January 21, 2013

Last Update Submit

December 28, 2022

Conditions

IVF Treatment

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Perform echo at home.

EXPERIMENTAL

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.

Interventions

Perform Echo at home.DEVICE

A group of women that follows an IVF treatment, will perform their echoes at home, instead of always make an appointment in the clinic.

Also known as: A home echo system will be used to perform an echo.
Perform echo at home.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Woman, suffering from subfertility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital VUB

Brussels, 1000, Belgium

Location

Hospital Oost-Limburg

Genk, 3600, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

Clinique Saint-Vincent

Rocourt, 4000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 24993931DERIVED

Related Links

Study Officials

  • Jan Gerris, Ph.D, M.D.

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2013

First Posted

January 31, 2013

Study Start

January 1, 2012

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

December 29, 2022

Record last verified: 2022-12

Locations

BE(4)