Fertilization in VitroHappy-FivNCT04213781
Interest of Audiovisual Distraction in the Management of Anxiety and Pain During Oocyte Retrieval
A study testing HappyMed Video Glasses, Propofol and Sufentanil in people with Fertilization in Vitro, run by CMC Ambroise Paré at 1 site in France.
Trial summary
Oocyte retrieval procedure for in vitro fertilization is a source of anxiety for patients. Local anaesthesia or sedation are commonly used to manage many situations of anxiety, including the oocyte retrieval. However, this sedation should be as mild as possible in order to preserve oocytes. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Fertilization in Vitro
- What is being tested?
- HappyMed Video Glasses, Propofol and Sufentanil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2020to 25 Nov 2020
- 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
- Patients undergoing oocyte retrieval requiring a sedation associating sufentanil and propofol
- Contactable by phone the day after the procedure.
- Consent for participation
- Affiliation to the social security system
Who cannot join
- Corneal or conjunctival diseases in progress,
- Claustrophobia
- Patients under protection of the adults (guardianship, curators or safeguard of justice)
- Communication difficulties or neuropsychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Audiovisual Distraction Decrease the Use of Hypnotic Drugs During Oocyte Retrieval?
Oocyte retrieval procedure for in vitro fertilization is a source of anxiety for patients. Local anaesthesia or sedation are commonly used to manage many situations of anxiety, including the oocyte retrieval. However, this sedation should be as mild as possible in order to preserve oocytes.
HappyMed Video Glasses are a recent medical device that allows the immersion of patients in films, cartoons or concerts. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care.
Read more
This randomized monocentric trial compares audiovisual distraction versus usual care for the management of anxiety and pain related to oocyte retrieval.
Hypothesis of this study is that the audiovisual distraction carried out with the HappyMed Video Glasses reduces the use of sedative drugs during oocyte retrieval while ensuring a better comfort and a faster walking ability.
Read the detailed description
Consent female patients between 18 and 43 years old scheduled for oocyte retrieval will be enrolled in this study and their anxiety level will be collected via a questionnaire.
After randomization, patients will either benefit from audiovisual distraction using HappyMed Video Glasses, (medical device with CE marking), or from the usual management during procedure. The anaesthesiologist will check that no anxiolytic or sedative drug was given 12 hours before anaesthesia. The patients will be stratified according to whether or not a previous intervention was performed. Anaesthesia will be started and maintained with administration of sufentanil (0.1 μg/kg) and propofol (using the Dixon's up-and-down method). The aim is a patient who spontaneously ventilates and does not react to gynaecological stimulation. Prevention of postoperative pain and nausea/vomiting will be carried out at the initiation of the surgical procedure. The effect of these drugs is longer than the intervention duration and will not influence the protocol.
- Conditions
- Fertilization in Vitro
- Being tested
- HappyMed Video Glasses, Propofol, Sufentanil
- Keywords
- Oocyte retrieval, Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HappyMed Video GlassesDevice
HappyMed allows the immersion of patients in films, cartoons or concerts.
PropofolDrug
The dosage is modified according to the Dixon's up-and-down method (using 0.5 µg/ml as a step size). The first patient in each group will start at a dose 3 µg/ml propofol. If patient manifests discomfort then the next patient will receive an increment of 0.5 µg/ml propofol, if patient is comfortable, then the next patient received a decrement of 0.5 µg/ml propofol.
SufentanilDrug
0.1 µg/kg
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Other | Sedation according to Dixon's up-and-down method. Receives: Drug: Propofol; Drug: Sufentanil |
| Audiovisual distraction | Experimental | Audiovisual distraction using HappyMed Video Glasses during procedure. Sedation according to Dixon's up-and-down method. Receives: Device: HappyMed Video Glasses; Drug: Propofol; Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target concentration of propofol administered during oocyte retrieval procedure to maintain the patient comfortable
An up and down method will define the CP 50 in each group.
Measured: Intraoperative period : from the start of anaesthesia to the end of the intervention
Secondary outcomes (7)
Side effects due to audiovisual distraction
Onset of vertigo, nausea or headaches
Measured: 4 hours
Patient comfort during propofol injection
Comfort behavior scale : it incorporates three categories of behavior : Facial expression (0=relaxed ; 1= frowning ; 2=grimacing) ; Verbal response (0=none ; 1= moans ; 2=verbal protest) ; Arm movement (0=none ; 1=medium ; 2=strong). Each scored on a 0-2-point scale so that the total score ranges from 0 to 6.
Measured: 30 minutes
Complications due to anaesthesia
Occurence of desaturation event (SpO2< 92%), respiratory distress event (RR<10 breaths per minute) or bronchospasm.
Measured: up to 24 hours (from the start of anaesthesia to the patient's discharge of the recovery room)
Resumption of walking
Duration between the end of the procedure and the standing position.
Measured: 12 hours
Health staff satisfaction
Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied).
Measured: 2 hours
Patient satisfaction
Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied).
Measured: 4 hours
Resuming activities of daily living
Numeric scale from 0 to 10 (0=bedridden, 10=resuming total activities).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start23 Sep 2020
- Primary completion24 Nov 2020
- Study completion25 Nov 2020
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 Fertilization in VitroStudies 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
- 36 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
- NCT04213781
- Sponsor's protocol ID
- 2019/02
- Acronym
- Happy-Fiv
- Status last verified
- Apr 2026
- First submitted
- 27 Dec 2019
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trou B, Pirtea P, Ma S, Aime I, Gross T, Kennel T, Jean-Marc A, Fischler M, Squara P, Le Guen M. Impact of pre-operative audiovisual distraction on consumption of hypnotics during transvaginal oocyte retrieval: A randomised controlled trial. Eur J Anaesthesiol. 2023 Aug 1;40(8):608-610. doi: 10.1097/EJA.0000000000001866. Epub 2023 Jun 22. No abstract available.
PubMed 37345747
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Audiovisual Distraction Decrease the Use of Hypnotic Drugs During Oocyte Retrieval?
- ClinicalTrials.gov ID
- NCT04213781
- Acronym / sponsor ID
- Happy-Fiv / 2019/02
- Conditions
- Fertilization in Vitro
- Keywords
- Oocyte retrieval, Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 30 Dec 2019 (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.
Oocyte retrieval procedure for in vitro fertilization is a source of anxiety for patients. Local anaesthesia or sedation are commonly used to manage many situations of anxiety, including the oocyte retrieval. However, this sedation should be as mild as possible in order to preserve oocytes.
HappyMed Video Glasses are a recent medical device that allows the immersion of patients in films, cartoons or concerts. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care.
This randomized monocentric trial compares audiovisual distraction versus usual care for the management of anxiety and pain related to oocyte retrieval.
Hypothesis of this study is that the audiovisual distraction carried out with the HappyMed Video Glasses reduces the use of sedative drugs during oocyte retrieval while ensuring a better comfort and a faster walking ability.
Detailed description
Consent female patients between 18 and 43 years old scheduled for oocyte retrieval will be enrolled in this study and their anxiety level will be collected via a questionnaire.
After randomization, patients will either benefit from audiovisual distraction using HappyMed Video Glasses, (medical device with CE marking), or from the usual management during procedure. The anaesthesiologist will check that no anxiolytic or sedative drug was given 12 hours before anaesthesia. The patients will be stratified according to whether or not a previous intervention was performed. Anaesthesia will be started and maintained with administration of sufentanil (0.1 μg/kg) and propofol (using the Dixon's up-and-down method). The aim is a patient who spontaneously ventilates and does not react to gynaecological stimulation. Prevention of postoperative pain and nausea/vomiting will be carried out at the initiation of the surgical procedure. The effect of these drugs is longer than the intervention duration and will not influence the protocol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Other | Drug: Propofol, Drug: SufentanilSedation according to Dixon's up-and-down method. |
| Audiovisual distraction | Experimental | Device: HappyMed Video Glasses, Drug: Propofol, Drug: SufentanilAudiovisual distraction using HappyMed Video Glasses during procedure. Sedation according to Dixon's up-and-down method. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients undergoing oocyte retrieval requiring a sedation associating sufentanil and propofol
- Contactable by phone the day after the procedure.
- Consent for participation
- Affiliation to the social security system
Key exclusion criteria (4 listed)
- Corneal or conjunctival diseases in progress,
- Claustrophobia
- Patients under protection of the adults (guardianship, curators or safeguard of justice)
- Communication difficulties or neuropsychiatric disorder
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 |
|---|---|---|
| HappyMed Video GlassesHappyMed allows the immersion of patients in films, cartoons or concerts. | Device | Audiovisual distraction |
| PropofolThe dosage is modified according to the Dixon's up-and-down method (using 0.5 µg/ml as a step size). The first patient in each group will start at a dose 3 µg/ml propofol. If patient manifests discomfort then the next patient will receive an increment of 0.5 µg/ml propofol, if patient is comfortable, then the next patient received a decrement of 0.5 µg/ml propofol. | Drug | Audiovisual distraction, Usual care |
| Sufentanil0.1 µg/kg | Drug | Audiovisual distraction, Usual care |
Primary outcome
Target concentration of propofol administered during oocyte retrieval procedure to maintain the patient comfortable
Time frame: Intraoperative period : from the start of anaesthesia to the end of the intervention
An up and down method will define the CP 50 in each group.
7 secondary outcomes
Side effects due to audiovisual distraction
Time frame: 4 hours
Patient comfort during propofol injection
Time frame: 30 minutes
Complications due to anaesthesia
Time frame: up to 24 hours (from the start of anaesthesia to the patient's discharge of the recovery room)
Resumption of walking
Time frame: 12 hours
Health staff satisfaction
Time frame: 2 hours
Patient satisfaction
Time frame: 4 hours
Resuming activities of daily living
Time frame: 24 hours
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 8 Apr 2026.
- Results publication: PubMed 37345747Trou B, Pirtea P, Ma S, Aime I, Gross T, Kennel T, Jean-Marc A, Fischler M, Squara P, Le Guen M. Impact of pre-operative audiovisual distraction on consumption of hypnotics during transvaginal oocyte retrieval: A randomised controlled trial. Eur J Anaesthesiol. 2023 Aug 1;40(8):608-610. doi: 10.1097/EJA.0000000000001866. Epub 2023 Jun 22. No abstract available.
- 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 HappyMed Video Glasses, Propofol and Sufentanil in people with Fertilization in Vitro, 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 4 inclusion and 4 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 8 Apr 2026. 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 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?
Target concentration of propofol administered during oocyte retrieval procedure to maintain the patient comfortable (time frame: Intraoperative period : from the start of anaesthesia to the end of the intervention). 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 NCT04213781, 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 8 Apr 2026.