Infertility Clinical Trial
Official title:
Efficacy of a Simulator Based (PickUpSimTM) Residents' Training Program for Oocyte Retrievals
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.
Hypotheses and Objectives The initial hypothesis was that the residents' lack of specific
training and inexperience would result in suboptimal oocyte retrievals, especially for their
first cases. This could potentially decrease the overall success rates of a
university-affiliated IVF unit (a lower oocyte yield would lead to a lower number of embryos,
thus decreasing pregnancy and live birth rates). The investigators aim to analyze whether
residents who had previous OPU simulation training would have better oocyte retrieval rates
than residents without pervious simulation training.
1. Primary objective 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 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.
2. Secondary objectives
The 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.
The investigators will use the following tools to analyze the secondary objectives:
- A survey filled by residents at the end of the first month of REI rotation. The first
part of the survey covers all aspects of the simulation training sessions (number and
duration, quality of scenarios, similarity to real life events), and will be completed
only by the residents who had the training sessions. However, the second part of the
survey includes questions about the residents' impressions while performing their first
oocyte retrievals on actual patients (stress levels, self-confidence…), and will be
completed by all residents.
- Analysis of data collected from the training sessions with PickUpSimTM. There are seven
scenarios in the training program, and each resident will complete each scenario twice.
For each scenario, the data collected will include: success or failure, reason for
failure, time needed for completion, and oocyte retrieval rate. Information will be
analyzed per resident in order to assess whether the competence level improves with
training.
- Collection and analysis of information regarding postoperative complications.
Postoperative complications are defined as a hemoperitoneum requiring a surgical
intervention, or infections requiring antibiotic therapy or a surgical intervention,
occuring in the month following the OPU.
- The oocyte retrieval rate of residents who had simulation training and those who did not
in the second and third month of REI rotation.
Methodology / Study diagram
The investigators will undertake a prospective comparative study at the IVF unit of the
Angers University Hospital between May 2019 and April 2022. The investigators will include
all residents in rotation at the IVF unit in that time period. The residents can decide
whether or not to partake in the study. 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 group allocation will be based on the timing of the
REI rotation: Residents rotating between May and November will be assigned to group A and
those rotating between November and May will be assigned to group B. In France, obstetrics
and gynecology residents switch rotations every semester (6 months), for a total period of
training of 5 years (10 semesters). Residents choose their own rotations, with minimum
requirements to obtain the national diploma. For instance, one semester in an REI department
is required for the obstetrics and gynecology diploma. Moreover, residents in "medical
gynecology" and "endocrinology" also have a 6 months rotation in an REI department. Most
often, residents choose the REI rotation towards the end of their training, in their last two
years. We will include in our study all residents rotating in the REI department (2 to 3 per
semester), regardless of their diploma or the year of training.
1. Simulation training program of group A
During the first 15 days of their REI rotation, residents will observe all OPU performed
by the department's senior physicians in the operating room, usually early in the
morning. Later during the day, the residents will take part in simulation sessions of 30
minutes duration, led by the same physician who performed the retrievals in the morning.
There will be a total of 4 training sessions, two sessions the first week, and two
sessions the second. The seven simulation scenarios available will be played out during
the first week, three in the first training session and four in the second. The
chronological order of scenarios will be randomly decided by the supervising physicians.
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 during the two sessions in the second
week and data collected again. Six different senior gynecologists will supervise the
simulation sessions: 3 attending physicians (Dr. Bouet, Dr. Dreux and Dr. Jeanneteau),
and 3 senior REI fellows (Dr. Faurant, Dr. Abnoun, and Dr. Delbos).
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 and the
senior the other. The choice of sides will not be predefined, but will be decided by the
attending and resident immediately before the procedure. A transvaginal ultrasound will
be performed to assess the feasibility of the retrieval and the accessibility of the
ovaries. If both ovaries are easily accessible, the decision will be made by mutual
consent. If one side is deemed more difficult, it will be handed to the senior.
During the retrieval, the operator will specify the number of follicles punctured for
each collected tube. The operating room nurse will assign a number to each tube (1, 2,
3…) and register on a separate paper the number of tubes and number of follicles
aspirated per tube. When one side is completed, and before changing operators, the
aspiration tubing is flushed and the content is added to the last tube, since some
oocytes may be stuck in the tubing. The same procedures are repeated for the second
operator (tube numbers, number of follicles, flushing). 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" (annex 3). Difficulties or incidents encountered during
the retrieval are also noted. The tubes are then passed in a specific container at 37°C
to the IVF laboratory, where the biology technicians will check the follicular fluid for
oocytes. The retrieval sheet is handed along with the container.
At the end of the first month of REI rotation, the residents will fill a 15 question
survey to evaluate their satisfaction with the simulation training program, and their
impressions while performing their first retrievals on patients . After the first month,
residents will start performing all the OPUs, including both ovaries, supervised by the
senior physicians, who will only intervene in difficult cases. Any senior intervention
will be noted on the retrieval sheets. The same procedures and data collection will be
conducted until the end of the semester.
2. Training program of Group B During the first 15 days of rotation, the residents will
only observe the seniors performing the retrievals in the operating room. Since there is
no simulation training, they will start performing OPU immediately after the observation
period. The OPU procedures and the data collection will be the same as in Group A (One
ovary first, tube numbers, number of follicles…). At the end of the first month, the
residents will fill the survey regarding their impressions during their first retrievals
. Following the first month, the residents start performing the entire retrievals,
supervised by seniors who only intervene in difficult cases. Residents in group B can
still use PickUpSimTM if they want to, but only after the first month and supervised by
physicians.
Inclusion and exclusion criteria
1. Inclusion criteria All residents starting their REI rotation at the IVF center at Angers
University Hospital between May 2018 and November 2020 will be included.
2. Exclusion criteria
- 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…).
Cases where the retrieval on one side is started by the resident but completed by the senior
physician will not be excluded, since we aim to perform an intention-to-treat analysis. We
will secondarily perform a per-protocol analysis, where these retrievals will be excluded.
Material The simulation training will be performed on PickUpSimTM. It is a high-fidelity
simulator for oocyte retrievals, developed by the company ACCURATE, and costing 20 000€.
PickUpSimTM has several benefits. First of all, it has a haptic feedback system that allows
the user to experience the resistance to penetration of the soft tissues, such as the ovarian
surface and the follicle wall resistance. It also has a virtual transvaginal echographic
monitor, and an ultrasound probe that can be rotated and moved in the transverse and sagittal
planes, allowing the user to explore the ovary and the surrounding tissues (blood vessels,
bowel loops…) in order to choose the best and safest entry plane for the retrieval. The
simulator allows for forward and backward movement of the needle, and permits simulation of
follicle emptying (with the use of a pedal pump) as well as flushing. The simulation
scenarios are based on real clinical images, and allow for a precise evaluation of the
trainee's performance, taking into account the proper movements to reach the desired
follicles, the proper suction and washing technique and time, and the avoidance of the
critical anatomical structures surrounding the ovary, such as blood vessels.
The simulation system is connected to a computer with an intuitive control software that
allows the user to modify the settings. For instance, the user can change the aspiration
pressure, add or remove the option of flushing the follicle, choose to activate aspiration
via the foot pedal or the computer, change the caliber of the needle, and even modify the
physics of the environment and the visibility of the needle in order to create more
challenging scenarios.
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