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

NCT ID: NCT01781143

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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IVF Treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Perform Echo at home.

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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A home echo system will be used to perform an echo.

Eligibility Criteria

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Inclusion Criteria

* Woman, suffering from subfertility.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Flanders Care

UNKNOWN

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Gerris, Ph.D, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital VUB

Brussels, , Belgium

Site Status

Hospital Oost-Limburg

Genk, , Belgium

Site Status

Ghent University Hospital

Ghent, , Belgium

Site Status

Clinique Saint-Vincent

Rocourt, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 24993931 (View on PubMed)

Related Links

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Other Identifiers

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2011/669

Identifier Type: -

Identifier Source: org_study_id