The U.S. Embryologist Fatigue Study (FUSE)

January 23, 2023 updated by: TMRW Life Sciences

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

246

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10013
        • TMRW Life Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • complete surveys from embryologists;

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
U.S. Embryologists
U.S. 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4-6 weeks
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.
4-6 weeks
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.
4-6 weeks
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.
4-6 weeks
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.
4-6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4-6 weeks
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.
4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TMRW Life Sciences

Collaborators

Dudley Associates Healthcare Marketing & Communications

Investigators

  • Principal Investigator: Michael Collins, PhD, TMRW Life Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2022

Primary Completion (Actual)

April 25, 2022

Study Completion (Actual)

May 30, 2022

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00062375

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

TMRW and Dudley Associates (DA) will keep a master list containing personal identifiers and responses separate from data forms (paper and electronic) that have only analyzed results. The master list will be on a separate computer at DA. This form of data is considered "coded" not de-identified. Since the data can be re-linked to identifiers, it is coded. Only after the key to the code or the Master List is destroyed are the data considered de-identified. External investigators will not have access to these files

The password-protected data will be stored on TMRW's drives in addition to the PIs' computers that are backed up according to TMRW's company policies

The coded data with personally identifiable information of the survey participants will be stored as described above. The participants' personal identifiers and other data will be destroyed, and data will hence be de-identified 5 years after study completion in compliance with TMRW Data Classification and Handling Policy

IPD Sharing Time Frame

The coded preliminary data will become available on April 15, 2022, and it will be available to other researchers at TMRW and external collaborators for a limited duration of time, while preparing the abstract for the conference, and writing and revising a paper for a peer-reviewed publication. Only TMRW Principal Investigators and Dudley Associates will have access to the master file and participants' personal identifiers for 5 years. The participants' personal identifiers and other data will be destroyed, and data will, therefore, be de-identified 5 years after study completion in compliance with TMRW Data Classification and Handling Policy.

IPD Sharing Access Criteria

All data and records generated during this survey will be kept confidential according to TMRW and Dudley Associates' policies on subject privacy and that the PIs and other TMRW personnel will not use them for any purpose other than conducting the study.

All data will be anonymized by DA, and no record with personal identifiers will be available to anyone except for DA and TMRW PIs. TMRW's collaborators will be bound by the NDA, protecting the data and scientific integrity of this study.

External collaborators will only be responsible for the data analysis, interpretation of the results, and co-authoring the abstract and a full peer-reviewed article using the coded data.

No identifiable data will be used for future study without first obtaining IRB approval or IRB determination of exemption. The investigator will obtain a data use agreement between the provider (TMRW PIs) and any recipient researchers before sharing a limited dataset.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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