Benefits of an Oocyte Pickup Simulation Training Program | NCT04130139

Studies
Benefits of an Oocyte Pickup Simulation Training Program

NCT04130139

Sponsor

University Hospital, Angers

Status

Unknown status

Last Update Posted

Oct 17, 2019Actual

Enrollment

46Actual

Phase

Not provided

Conditions

Simulation Training
IVf
Education

Interventions

oocyte pick up simulator

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Sep 1, 2017Actual

Completion Date

Nov 1, 2019Estimated

First Submitted Date

Oct 10, 2019

First Submission Date that Met QC Criteria

Oct 15, 2019

First Posted Date

Oct 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2019

Last Update Posted Date

Oct 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
residents		obstetrics and gynecology residents from France with or without previous experience in oocyte pick up	Other: oocyte pick up simulator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oocyte pick up simulator	Other	oocyte pick up simulation	residents

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
successful scenario	oocyte retrieval rate >=70%	1 day

Secondary Outcomes

Measure	Description	Time Frame
completion time	time to successfully complete the scenario	1 day
complications	complications that may occurs during the simulation training (lesions of vitals organs, forget to change collection tubes)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

obstetrics and gynecology residents
french residents

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre Emmanuel Bouet, MD	Centre hospitalier d'Angers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire Angers		Angers		49100	France