Efficacy of a Simulator Based (PickUpSimTM) Residents' Training Program for Oocyte Retrievals
1 other identifier
interventional
15
1 country
1
Brief Summary
Simulation is an educational approach that has recently found an application in healthcare.acquire. Angers university hospital has decided to acquire, in December 2016, the high-fidelity Oocyte Pick up (OPU) simulator PickUpSimTM, and the investigators have put in place a training novel program containing different simulation based courses. It is essential to analyze its impact on the clinical practice before implementing it on a larger scale. Initial hypothesis was that the residents' lack of specific training and inexperience would result in suboptimal oocyte retrievals, especially for their first cases The investigators will undertake a prospective comparative study at the In Vitro Fertilization (IVF) unit of the Angers University Hospital between May 2019 and April 2022. The investigators will include all voluntary residents in rotation at the IVF unit in that time period. The participants will be divided in two groups: Group A will undergo the PickUpSimTM simulation training program whereas group B will only have the classic training with no simulation. The primary objective is to assess the benefits of an OPU simulation training program using the PickUpSimTM simulator for teaching residents in a university-affiliated IVF center. The main criterion the investigators will use is the "oocyte retrieval rate" (ORR) during the first month following 15 days of simulation training. The ORR is calculated as the number of oocytes retrieved divided by the number of follicles aspirated. Our secondary objectives are:
- To assess the residents' satisfaction with the simulation training program.
- To evaluate the learning curve of residents during the two weeks of training.
- To compare the OPU complication rate between residents with and without previous simulation training.
- To analyze the oocyte retrieval rate in the second and third month of REI rotation for residents, and compare it between those with and those without simulation training.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 24, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedOctober 9, 2018
October 1, 2018
3 years
September 24, 2018
October 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
oocyte retrieval rate during the first month following 15 days of simulation training.
The ORR is calculated as the number of oocytes retrieved divided by the number of follicles aspirated
6 month
Secondary Outcomes (4)
the residents' satisfaction with the simulation training program
6 month
evaluate the learning curve of residents during the two weeks of training.
6 month
compare the OPU complication rate between residents with and without previous simulation training
6 month
the oocyte retrieval rate in the second and third month of REI rotation for residents
6 month
Study Arms (2)
Group A
EXPERIMENTALGroup A will undergo the PickUpSimTM simulation training program
Group B
NO INTERVENTIONGroup B will only have the classic training with no simulation.
Interventions
The residents will take part in simulation sessions of 30 minutes duration. There will be 4 training sessions with seven simulation scenarios available. During the sessions, the following data will be collected for each scenario success or failure, reason for failure, time needed for completion, and oocyte retrieval rate. All scenarios will be repeated in the same conditions in the second week and data collected again. In the following 15 days, residents will start performing OPU, under direct supervision from senior physicians. For each patient, the resident will puncture one ovary. During the retrieval, the operator will specify the number of follicles punctured for each collected tube. The identity of the operator and the number of follicles punctured (per tube and in total) are noted on a separate sheet entitled the "retrieval sheet". After the first month, residents will start performing all the OPUs, including both ovaries, supervised by the senior physicians.
Eligibility Criteria
You may qualify if:
- All voluntary residents starting their REI rotation at the IVF center at Angers University Hospital between May 2018 and November 2020 will be included.
You may not qualify if:
- Residents who refuse to partake in the study.
- Residents who have already performed OPU during their residency training.
- Retrieval sheets missing any kind of information (number of tubes or follicles, absent identification…).
- Difficult OPU cases that end up being performed entirely by the senior physician (difficult visualization or access, mobile ovaries…).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Angers university hospital
Angers, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2018
First Posted
October 9, 2018
Study Start
May 1, 2018
Primary Completion
April 30, 2021
Study Completion
April 30, 2021
Last Updated
October 9, 2018
Record last verified: 2018-10