Clinical trial NCT05326802: The U.S. Embryologist Fatigue Study
Official title: Occupational Physical and Mental Health Issues Experienced by U.S. Embryologists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatigue
Stress
Burnout, Professional
Musculoskeletal Pain
Back Pain
Neck Pain
Headache
Dizziness
Sleep Disturbance
Chest Pain
Syncope
Cardiovascular Diseases
Shortness of Breath
Gastrointestinal Diseases
Keywords: embryologist
stress
fatigue
burnout
physical health
IVF
Lead sponsor: TMRW Life Sciences
Sponsor class: INDUSTRY
Collaborators: name: Dudley Associates Healthcare Marketing & Communications
First posted: 2022-04-14
Enrollment: 246
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Embryologists are the ART/IVF/embryology laboratory personnel who provide fertility and embryology services, including but not limited to IVF procedures, pre-implantation genetic testing of embryos, freezing/vitrification of embryos and gametes, cryomanagement of frozen/vitrified embryos and gametes, and monitoring and maintenance of laboratory records and equipment. They range in age, gender, marital status, children, and relationship status, but they must have a minimum of B.A./B.S. degree, and ELS (AAB) or other professional certifications to work as an embryology laboratory technologist or supervisor, and a postgraduate degree, such as Ph.D., M.D., or D.O. to serve as the embryology laboratory director. Embryologists of all career levels work in a private, academic, government, or corporate IVF clinical/laboratory on a full-time, part-time, or per-diem basis, and with a permanent or a non-permanent contract.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* complete surveys from embryologists;

Exclusion Criteria:

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

Primary outcomes:
measure: The sociodemographic characteristics of U.S. embryologists
timeFrame: 4-6 weeks
measure: The work-related health status of U.S. embryologists
timeFrame: 4-6 weeks
measure: The work-related stress and fatigue among U.S. embryologists
timeFrame: 4-6 weeks
measure: The work-related burnout amount U.S. embryologists
timeFrame: 4-6 weeks
measure: Potential strategies to reduce stress, fatigue, and burnout in U.S. Embryologists
timeFrame: 4-6 weeks
Secondary outcomes:
measure: The underlying causes of work-related physical and mental health issues in U.S. Embryologists
timeFrame: 4-6 weeks
measure: The correlation between negative health outcomes, manual workload, and error among U.S. embryologists
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: TMRW Life Sciences
state: New York
Study officials:
affiliation: TMRW Life Sciences
name: Anar Murphy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: TMRW Life Sciences
name: Michael Collins, PhD
role: PRINCIPAL_INVESTIGATOR
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