Infertility Clinical Trial
Official title:
Efficacy of a Simulator Based (PickUpSimTM) Residents' Training Program for Oocyte Retrievals
NCT number | NCT03700255 |
Other study ID # | 2018/03 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | April 30, 2021 |
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | April 30, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All voluntary residents starting their REI rotation at the IVF center at Angers University Hospital between May 2018 and November 2020 will be included. 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…). |
Country | Name | City | State |
---|---|---|---|
France | Angers university hospital | Angers |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | the residents' satisfaction with the simulation training program | A survey filled by residents at the end of the first month of REI rotation | 6 month | |
Secondary | evaluate the learning curve of residents during the two weeks of training. | Analysis of data collected from the training sessions with PickUpSimTM. There are seven scenarios in the training program | 6 month | |
Secondary | compare the OPU complication rate between residents with and without previous simulation 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 | 6 month | |
Secondary | the oocyte retrieval rate in the second and third month of REI rotation for residents | • The oocyte retrieval rate of residents who had simulation training and those who did not in the second and third month of REI rotation. | 6 month |
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