IVFVR-INVENTNCT05925400
Interest of Virtual Reality in the Management of Anxiety and Pain During Embryo Transfer (ET)
A study testing Virtual Reality during Embryo Transfer in people with IVF and Stress, run by CMC Ambroise Paré at 1 site in France.
Trial summary
This study compares the use of virtual Reality versus the usual service protocol for the management of anxiety and pain related to In-Vitro fertilization (IVF) procedure Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- What is being tested?
- Virtual Reality during Embryo Transfer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2023to 16 Jul 2025
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Will benefit from in vitro Fertilization (IVF or ICSI)
- Aged over 18 and under 43,
- Attempt Rank 1 or 2
- Requiring a transfer of a single fresh blastocyst on the 5th day of development OR a frozen embryo on the 5th day of development
- Having received information and given their consent to participate in accordance with the regulations
- Benefiting from a social security scheme or entitled.
Who cannot join
- Use of frozen sperm
- Use of testicular sperm
- Fecundation technique used: IMSI
- Early embryo transfer on D2 or D3
- Inability to understand the information given
- Under guardianship, under curatorship or under safeguard of justice,
Show all 11Show fewer
- Communication difficulties or neuropsychic disorders,
- Current corneal or conjunctival pathologies,
- Claustrophobia,
- Appearance of nausea in the mountains or at sea,
- Regular use of anxiolytics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Virtual Reality On IN-Vitro fEcuNdation ouTcomes: a Randomized Controlled Trial (VR-INVENT)
This study compares the use of virtual Reality versus the usual service protocol for the management of anxiety and pain related to In-Vitro fertilization (IVF) procedure
Read the detailed description
Medical interventions often cause pain, distress or anxiety for most patients.
The use of music and movies has proven effective in pediatrics.
Virtual Reality (VR) is a newer technology that immerses users in a pleasant, three-dimensional environment via a headset. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care.
This randomized monocentric trial compares the effect of the use of VR versus without VR during the transfer of a fresh blastocyst on the 5th day of development OR a frozen embryo on the 5th day of development.
The primary outcome will include clinical pregnancy rate and the secondary outcome focuses on the patient's levels of anxiety and stress.
Data on the level of anxiety and stress will be collected through questionnaires before and after the procedure. Also, clinical pregnancy, defined by the presence of one or more gestational sacs with one or more embryos showing cardiac activity, will be assessed through ultrasons 8 ± 4 weeks after the procedure
- Being tested
- Virtual Reality during Embryo Transfer
- Keywords
- Virtual Reality, Embryo transfer, Pregnancy rate
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality during Embryo TransferDevice
Patients randomized to the study group, will be provided with the VR headset. The VR exposure will take place 10-15 minutes before the Embryo Transfer (ET) and a 10 min immersion after the ET
| Study group | Role | What they receive |
|---|---|---|
| ET without RV | No intervention | Patients who will be randomized to the control group will wait for transfer of a fresh blastocyst on the 5th day of development OR a frozen embryo on the 5th day of development according to the usual service protocol. |
| ET with RV | Experimental | The transfer and preparation in the transfer room will be done according to the usual service protocol.
Exposure to virtual reality environment exposure Receives: Device: Virtual Reality during Embryo Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate
Clinical Pregnancy Rate defined by the presence of one or more gestational sacs with one or more embryos showing cardiac activity
Measured: Assessed 12 weeks after embryo transfer
Secondary outcomes (2)
State and Trait Anxiety Inventory (STAI) questionnaires
The rate of anxiety and stress level before and after embryo transfer, measured by the State and Trait Anxiety Inventory (STAI) StAI-Y1-State ranging from 20 to 80 (20 = Low Level of Anxiety), 80 = High Level Of Anxiety) StAI-Y2-Trait ranging from 20 to 80 (20 = Low Level of Anxiety), 80 = High Level Of Anxiety)
Measured: Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 45 minutes before ET 2) ET day, 10 minutes after ET procedure
Generalized Anxiety Disorder - 7 (GAD-7) questionnaires
The rate of anxiety and stress level before and after embryo transfer, measured by Generalized Anxiety Disorder - 7 (GAD-7) questionnaires GAD-7 ranging from 0 to 21 (0= No or Minimal Stress, 21= Worst Possible Stress)
Measured: Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 45 minutes before ET 2) ET day, 10 minutes after ET procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start15 Nov 2023
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Why it stopped: Insufficient enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925400
- Sponsor's protocol ID
- 2022/02
- Acronym
- VR-INVENT
- Status last verified
- Jul 2025
- First submitted
- 21 Jun 2023
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality On IN-Vitro fEcuNdation ouTcomes: a Randomized Controlled Trial (VR-INVENT)
- ClinicalTrials.gov ID
- NCT05925400
- Acronym / sponsor ID
- VR-INVENT / 2022/02
- Keywords
- Virtual Reality, Embryo transfer, Pregnancy rate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment rate
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 29 Jun 2023 (actual)
- 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.
This study compares the use of virtual Reality versus the usual service protocol for the management of anxiety and pain related to In-Vitro fertilization (IVF) procedure
Detailed description
Medical interventions often cause pain, distress or anxiety for most patients.
The use of music and movies has proven effective in pediatrics.
Virtual Reality (VR) is a newer technology that immerses users in a pleasant, three-dimensional environment via a headset. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care.
This randomized monocentric trial compares the effect of the use of VR versus without VR during the transfer of a fresh blastocyst on the 5th day of development OR a frozen embryo on the 5th day of development.
The primary outcome will include clinical pregnancy rate and the secondary outcome focuses on the patient's levels of anxiety and stress.
Data on the level of anxiety and stress will be collected through questionnaires before and after the procedure. Also, clinical pregnancy, defined by the presence of one or more gestational sacs with one or more embryos showing cardiac activity, will be assessed through ultrasons 8 ± 4 weeks after the procedure
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ET without RV | No intervention | –Patients who will be randomized to the control group will wait for transfer of a fresh blastocyst on the 5th day of development OR a frozen embryo on the 5th day of development according to the usual service protocol. |
| ET with RV | Experimental | Device: Virtual Reality during Embryo TransferThe transfer and preparation in the transfer room will be done according to the usual service protocol. Exposure to virtual reality environment exposure |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Will benefit from in vitro Fertilization (IVF or ICSI)
- Aged over 18 and under 43,
- Attempt Rank 1 or 2
- Requiring a transfer of a single fresh blastocyst on the 5th day of development OR a frozen embryo on the 5th day of development
- Having received information and given their consent to participate in accordance with the regulations
Key exclusion criteria (11 listed)
- Use of frozen sperm
- Use of testicular sperm
- Fecundation technique used: IMSI
- Early embryo transfer on D2 or D3
- Inability to understand the information given
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 |
|---|---|---|
| Virtual Reality during Embryo TransferPatients randomized to the study group, will be provided with the VR headset. The VR exposure will take place 10-15 minutes before the Embryo Transfer (ET) and a 10 min immersion after the ET | Device | ET with RV |
Primary outcome
Clinical Pregnancy Rate
Time frame: Assessed 12 weeks after embryo transfer
Clinical Pregnancy Rate defined by the presence of one or more gestational sacs with one or more embryos showing cardiac activity
2 secondary outcomes
State and Trait Anxiety Inventory (STAI) questionnaires
Time frame: Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 45 minutes before ET 2) ET day, 10 minutes after ET procedure
Generalized Anxiety Disorder - 7 (GAD-7) questionnaires
Time frame: Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 45 minutes before ET 2) ET day, 10 minutes after ET procedure
Results and safety
The study was stopped early (reason given: Insufficient enrollment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality during Embryo Transfer in people with IVF and Stress, run by CMC Ambroise Paré at 1 site in France.
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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 was stopped early (reason given: Insufficient enrollment rate). Results are not available in the source record.
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?
Clinical Pregnancy Rate (time frame: Assessed 12 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2025.