Simulation TrainingNCT04130139
Benefits of an Oocyte Pickup Simulation Training Program
An observational study of Simulation Training and IVf, run by University Hospital, Angers at 1 site in France.
Trial summary
The primary objective of this study was to evaluate oocyte pick up simulation training program for teaching residents. The secondary objectives were to evaluate resident satisfaction and the overall current state of oocyte pick up training in France. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Simulation Training, IVf, Education
- What is being tested?
- oocyte pick up simulator
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2017to 1 Nov 2019
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: obstetrics and gynecology residents from France participating in a national training conference organized by the national college of french gynecologists and obstetricians.
Who may be able to join
- obstetrics and gynecology residents
- french residents
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of an Oocyte Pickup Simulation Training Program Using a High-fidelity Simulator for Obstetrics and Gynecology Residents
The primary objective of this study was to evaluate oocyte pick up simulation training program for teaching residents. The secondary objectives were to evaluate resident satisfaction and the overall current state of oocyte pick up training in France.
Read the detailed description
simulation workshop using PickupSim simulator. inclusion: obstetrics and gynecology residents from France simulator: 7 scenarios available
1 simulation training/resident main outcome: successful completion of the scenario (oocyte retrieval rate >=70%) secondary outcome: time for completion, complications, satisfaction survey
- Conditions
- Simulation Training, IVf, Education
- Being tested
- oocyte pick up simulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oocyte pick up simulatorOther
oocyte pick up simulation
| Study group | Role | What they receive |
|---|---|---|
| residents | obstetrics and gynecology residents from France with or without previous experience in oocyte pick up Receives: Other: oocyte pick up simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful scenario
oocyte retrieval rate >=70%
Measured: 1 day
Secondary outcomes (2)
completion time
time to successfully complete the scenario
Measured: 1 day
complications
complications that may occurs during the simulation training (lesions of vitals organs, forget to change collection tubes)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start1 Aug 2017
- Primary completion1 Sep 2017
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation TrainingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre Emmanuel Bouet, MD, Principal investigator, Centre hospitalier d'Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130139
- Sponsor's protocol ID
- Pickupsim
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of an Oocyte Pickup Simulation Training Program Using a High-fidelity Simulator for Obstetrics and Gynecology Residents
- ClinicalTrials.gov ID
- NCT04130139
- Acronym / sponsor ID
- Pickupsim
- Conditions
- Simulation Training, IVf, Education
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 17 Oct 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.
The primary objective of this study was to evaluate oocyte pick up simulation training program for teaching residents. The secondary objectives were to evaluate resident satisfaction and the overall current state of oocyte pick up training in France.
Detailed description
simulation workshop using PickupSim simulator. inclusion: obstetrics and gynecology residents from France simulator: 7 scenarios available
1 simulation training/resident main outcome: successful completion of the scenario (oocyte retrieval rate >=70%) secondary outcome: time for completion, complications, satisfaction survey
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| residents | – | Other: oocyte pick up simulatorobstetrics and gynecology residents from France with or without previous experience in oocyte pick up |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- obstetrics and gynecology residents from France participating in a national training conference organized by the national college of french gynecologists and obstetricians.
Key inclusion criteria (2 listed)
- obstetrics and gynecology residents
- french residents
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| oocyte pick up simulatoroocyte pick up simulation | Other | residents |
Primary outcome
successful scenario
Time frame: 1 day
oocyte retrieval rate >=70%
2 secondary outcomes
completion time
Time frame: 1 day
complications
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
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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.
Pierre Emmanuel Bouet, MD principal investigator
Centre hospitalier d'Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Simulation Training and IVf, run by University Hospital, Angers 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Oct 2019. 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?
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?
successful scenario (time frame: 1 day). 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 17 Oct 2019.