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Completed

NCT Number: NCT05326802

The U.S. Embryologist Fatigue Study

The purpose of the study is to determine physical and mental health issues of U.S. 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.

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Key information

Conditions

Fatigue Back Pain Behavior Behavioral Symptoms Burnout, Professional Burnout, Psychological Cardiovascular Diseases Chest Pain Consciousness Disorders Digestive System Diseases Dizziness Dyspnea Gastrointestinal Diseases Headache Mental Disorders Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neck Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Occupational Diseases Occupational Stress Pain Parasomnias Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sensation Disorders Shortness of Breath Signs and Symptoms Signs and Symptoms, Respiratory Sleep Disturbance Sleep Wake Disorders Stress Stress, Psychological Syncope Unconsciousness

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

TMRW Life Sciences

New York, 10013, United States

About this study

Embryologist fatigue surveys conducted in Spain and the United Kingdom reported that embryologists experience work-related mental health issues similar to surgeons in the United States (36.3% in Spanish and 27.8% in U.K. embryologists v. 34% in U.S. surgeons), as well as high rates of self-reported, work-related MSDs despite taking better care of themselves than the average population. Among prevalent mental issues, they highlighted fatigue, stress, and burnout 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.S. 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • complete surveys from embryologists;

Exclusion criteria

  • incomplete surveys from embryologists; complete and incomplete surveys from non-embryologists.

Treatment and study plan

Primary outcomes

  1. The sociodemographic characteristics of U.S. embryologists

    Time frame: 4-6 weeks

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

  2. The work-related health status of U.S. embryologists

    Time frame: 4-6 weeks

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

  3. The work-related stress and fatigue among U.S. embryologists

    Time frame: 4-6 weeks

    The stress and fatigue experienced by U.S. 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.S. embryologists

    Time frame: 4-6 weeks

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

  5. Potential strategies to reduce stress, fatigue, and burnout in U.S. Embryologists

    Time frame: 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 outcomes

  1. The underlying causes of work-related physical and mental health issues in U.S. Embryologists

    Time frame: 4-6 weeks

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

  2. The correlation between negative health outcomes, manual workload, and error among U.S. embryologists

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

TMRW Life Sciences

Industry

Collaborators

  • Dudley Associates Healthcare Marketing & Communications

Registry information

Official study title

Occupational Physical and Mental Health Issues Experienced by U.S. Embryologists

Acronym: FUSE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2022
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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