FUSE-UK: The U.K. Embryologist Fatigue Study

Sponsor
TMRW Life Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT05708963
Collaborator
Dudley Associates Healthcare Marketing & Communications (Other)
123
1
17
220.2

Study Details

Study Description

Brief Summary

The purpose of the study is to determine physical and mental health issues of U.K. embryologists related to their occupational characteristics, and how workplace fatigue and burnout may affect their quality of life, cynicism, interactions with patients, attention to detail, and lead to human error, the cause of the most severe IVF incidents that often make headlines and result in costly litigation. It will also correlate how the current manual workflows contribute to these health issues, and what measures can be taken to improve both working conditions and embryologists' health, and, therefore, improve patient care.

Detailed Description

Embryologist fatigue surveys conducted in Spain, the United States, and the international survey of embryologists from 85 countries reported that embryologists experience work-related fatigue, stress, and burnout. They named those as contributing factors to decreased efficiency, cynicism, and emotional exhaustion, which, together with having to handle the increasing cycle volume using conventional, manual protocols of cryomanagement, can lead to human error and IVF incidents. The known IVF incidents resulted in lost, damaged, or misplaced embryos and gametes, lawsuits, and reputational damage to patients and providers. In the absence of a "better than" cryopreservation storage solution, many programs just turned to buying more tanks and alarms and/or added expensive staff. The more effective solutions should focus on optimizing workflows by adopting innovation like automation and a digital chain of custody, organizational changes that will lead to a more productive, collaborative, and rewarding work environment, allowing embryologists to focus on patient care, scientific research, innovation, and career planning, and fewer incidents and lawsuits.

The purpose of this cross-sectional study using a web-based survey is to determine physical and mental health issues of U.K. embryologists related to their occupational characteristics, and how workplace fatigue and burnout may affect their quality of life, cynicism, interactions with patients, attention to detail, and lead to human error, the cause of the most severe IVF incidents that often make headlines and result in costly litigation. It will also correlate how the current manual workflows contribute to these health issues, and what measures can be taken to improve both working conditions and embryologists' health, and, therefore, improve patient care.

Study Design

Study Type:
Observational
Actual Enrollment :
123 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Occupational Physical Health Issues, Stress, Fatigue, and Burnout Experienced by U.K. Embryologists
Actual Study Start Date :
Jan 16, 2023
Actual Primary Completion Date :
Jan 26, 2023
Actual Study Completion Date :
Feb 2, 2023

Arms and Interventions

Arm Intervention/Treatment
U.K. Embryologists

U.K. embryologists of all ages, career levels, and other sociodemographic groups will be asked questions about their physical and mental health related to their occupational characteristics using the nationally validated surveys and questionnaires, and also about their working conditions in the ART/IVF laboratories using a custom occupational questionnaire and the single-item work unit grade (A-F).

Outcome Measures

Primary Outcome Measures

  1. The sociodemographic characteristics of U.K. embryologists [4-6 weeks]

    The sociodemographic characteristics of U.K. embryologists whose routine work duties include IVF procedures and freezing and cryomanagement of embryos and gametes.

  2. The work-related health status of U.K. embryologists [4-6 weeks]

    The overall health status of U.K. embryologists and associated health issues related to their professional duties.

  3. The work-related stress and fatigue among U.K. embryologists [4-6 weeks]

    The stress and fatigue experienced by U.K. embryologists because of their reliance on manual procedures, the need for a high degree of attention to avoid errors and litigation and depending on human intervention to respond to emergencies in the laboratory.

  4. The work-related burnout amount U.K. embryologists [4-6 weeks]

    The burnout experienced by U.K. embryologists because of their stress and fatigue.

  5. Potential strategies to reduce stress, fatigue, and burnout in U.K. Embryologists [4-6 weeks]

    The potential strategies, such as organizational changes and automation of cryomanagement protocols, to alleviate physical strain and stress, and to prevent fatigue and burnout that can reduce the embryologist's attention to detail and contribute to IVF errors.

Secondary Outcome Measures

  1. The underlying causes of work-related physical and mental health issues in U.K. Embryologists [4-6 weeks]

    The underlying causes of physical strain, stress, fatigue, and burnout in U.K. embryologists related to their occupational characteristics.

  2. The correlation between negative health outcomes, manual workload, and error among U.K. embryologists [4-6 weeks]

    How we can correlate these negative health outcomes and potential for human error they can cause, and link them to the overreliance of embryologists on outdated technology that adds time and stress to their workload.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • complete surveys from embryologists
Exclusion Criteria:
  • incomplete surveys from embryologists; complete and incomplete surveys from non-embryologists.

Contacts and Locations

Locations

Site City State Country Postal Code
1 TMRW Life Sciences New York New York United States 10013

Sponsors and Collaborators

  • TMRW Life Sciences
  • Dudley Associates Healthcare Marketing & Communications

Investigators

  • Principal Investigator: Anar Murphy, PhD, TMRW Life Sciences

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
TMRW Life Sciences
ClinicalTrials.gov Identifier:
NCT05708963
Other Study ID Numbers:
  • Pro00062375-2
First Posted:
Feb 1, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by TMRW Life Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023