Efficacy of a Simulator Based (PickUpSimTM) Residents' Training Program for Oocyte Retrievals

NCT03700255 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-10-09

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

PickUpSimTM simulation training program

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.

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03700255 on ClinicalTrials.gov