An interventional study of HappyMed Video Glasses and Propofol in Fertilization in Vitro, sponsored by CMC Ambroise Paré. Completed at 1 site in France. Open to female participants aged 18 Years to 43 Years. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by CMC Ambroise Paré · Not applicable, Interventional, and Other
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.
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.
CMC Ambroise Paré is the lead sponsor of 47 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sedation according to Dixon's up-and-down method.
Drug: Propofol · Drug: Sufentanil
Audiovisual distraction using HappyMed Video Glasses during procedure. Sedation according to Dixon's up-and-down method.
Device: HappyMed Video Glasses · Drug: Propofol · Drug: Sufentanil
HappyMed allows the immersion of patients in films, cartoons or concerts.
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.
0.1 µg/kg
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.
Time frame: Intraoperative period : from the start of anaesthesia to the end of the intervention
Side effects due to audiovisual distraction
Onset of vertigo, nausea or headaches
Time frame: 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.
Time frame: 30 minutes
Complications due to anaesthesia
Occurence of desaturation event (SpO2\< 92%), respiratory distress event (RR\<10 breaths per minute) or bronchospasm.
Time frame: 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.
Time frame: 12 hours
Health staff satisfaction
Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied).
Time frame: 2 hours
Patient satisfaction
Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied).
Time frame: 4 hours
Resuming activities of daily living
Numeric scale from 0 to 10 (0=bedridden, 10=resuming total activities).
Time frame: 24 hours
Plan to share: No
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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CMC Ambroise Paré