Clinical Efficacy of Virtual Reality During Office Hysteroscopy and Endometrial Biopsy in Subfertility (HYSVIR)

Universitair Ziekenhuis Brussel

Status: Completed

Conditions: Infertility, Female

Treatments: Device: Oncomfort, commercially available Virtual Reality headset

Study type: Interventional

Funder types: Other

Identifiers

NCT04438759

HYSVIR

Details and patient eligibility

About

This study is a comparison between the current standard practice of performing a diagnostic hysteroscopy and a relatively recently developed technology that is added to the standard diagnostic hysteroscopy. The aim of the study is to find out whether this newer technology has an advantage for the patient, in the form of anxiety and pain reduction.

Enrollment: 216 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• undergoing fertility treatments
• for which outpatient hysteroscopy has been prescribed
• for different possible indications: suspicion of intracavitary pathology, recurrent implantation failure, recurrent early pregnancy loss, ...

Exclusion criteria

1. Hearing impairments and blindness
2. Motion sickness
3. Any known anatomical characteristics that may make performing the office procedure impossible.
4. The unwillingness of the patient to undergo an office hysteroscopy
5. Denial or withdrawal of informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

investigational group

Experimental group

Description:

Virtual Reality

Treatment:

Device: Oncomfort, commercially available Virtual Reality headset

reference group

No Intervention group

Description:

standard of care