IVF TreatmentSOETNCT01781143
Self-operated Endo-vaginal Telemonitoring (SOET), an Economic and Patient-empowered Method for Ovarian Stimulation for In-vitro Fertilization (IVF)
A study testing Perform Echo at home. in people with IVF Treatment, run by University Hospital, Ghent at 4 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- IVF Treatment
- What is being tested?
- Perform Echo at home.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 4 sitesBelgium
- Study dates
- Jan 2012to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Woman, suffering from subfertility.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
University Hospital VUB
Brussels, 1000
Hospital Oost-Limburg
Genk, 3600
Ghent University Hospital
Ghent, 9000
Clinique Saint-Vincent
Rocourt, 4000
About this study
Official title: 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.
- Conditions
- IVF Treatment
- Being tested
- Perform Echo at home.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perform Echo at home.Device
Also called A home echo system will be used to perform an echo.
A group of women that follows an IVF treatment, will perform their echoes at home, instead of always make an appointment in the clinic.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Perform Echo at home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 2 days, up to a year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IVF TreatmentStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Flanders Care
- Responsible party
- Sponsor
- Investigators
- Jan Gerris, Ph.D, M.D., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781143
- Sponsor's protocol ID
- 2011/669
- Acronym
- SOET
- Status last verified
- Dec 2022
- First submitted
- 21 Jan 2013
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24993931
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-operated Endo-vaginal Telemonitoring (SOET), an Economic and Patient-empowered Method for Ovarian Stimulation for In-vitro Fertilization (IVF).
- ClinicalTrials.gov ID
- NCT01781143
- Acronym / sponsor ID
- SOET / 2011/669
- Conditions
- IVF Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Flanders Care
- Study start
- Jan 2012 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perform echo at home. | Experimental | 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Woman, suffering from subfertility.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perform Echo at home.Also: A home echo system will be used to perform an echo.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. |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Derived from this study: PubMed 24993931Gerris 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Gerris, Ph.D, M.D. principal investigator
University Hospital, Ghent
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perform Echo at home. in people with IVF Treatment, run by University Hospital, Ghent at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Higher efficacy by taking an echo at home. (time frame: Every 2 days, up to a year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01781143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.