The U.S. Embryologist Fatigue Study

NCT05326802 | Completed DMC

• 1 other identifier: Pro00062375
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• The sociodemographic characteristics of U.S. embryologists

  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

  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

  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

  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

  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 Outcomes (2)

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

  4-6 weeks

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

  4-6 weeks

Study Arms (1)

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).

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• complete surveys from embryologists;

You may not qualify if:

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

Sponsors & Collaborators

• TMRW Life Sciences: lead
• Dudley Associates Healthcare Marketing & Communications: collaborator

Study Sites (1)

TMRW Life Sciences

New York, New York, 10013, United States

Location

Related Publications (15)

• Lopez-Leria B, Jimena P, Clavero A, Gonzalvo MC, Carrillo S, Serrano M, Lopez-Regalado ML, Olvera C, Martinez L, Castilla JA. Embryologists' health: a nationwide online questionnaire. J Assist Reprod Genet. 2014 Dec;31(12):1587-97. doi: 10.1007/s10815-014-0352-7. Epub 2014 Oct 5.

  PMID: 25284212 BACKGROUND

• Tawfik DS, Profit J, Morgenthaler TI, Satele DV, Sinsky CA, Dyrbye LN, Tutty MA, West CP, Shanafelt TD. Physician Burnout, Well-being, and Work Unit Safety Grades in Relationship to Reported Medical Errors. Mayo Clin Proc. 2018 Nov;93(11):1571-1580. doi: 10.1016/j.mayocp.2018.05.014. Epub 2018 Jul 9.

  PMID: 30001832 BACKGROUND

• Priddle H, Pickup S, Hayes C; Association of Reproductive and Clinical Scientists (ARCS). Occupational health issues experienced by UK embryologists: informing improvements in clinical reproductive science practice. Hum Fertil (Camb). 2022 Oct;25(4):608-617. doi: 10.1080/14647273.2021.1871782. Epub 2021 Jan 18.

  PMID: 33459106 BACKGROUND

• Practice Committee of the American Society for Reproductive Medicine; Practice Committee of the Society for Assisted Reproductive Technology; Practice Committee of the Society of Reproductive Biologists and Technologists. Recommended practices for the management of embryology, andrology, and endocrinology laboratories: a committee opinion. Fertil Steril. 2014 Oct;102(4):960-3. doi: 10.1016/j.fertnstert.2014.06.036. Epub 2014 Jul 23.

  PMID: 25064400 BACKGROUND

• Practice Committee of the American Society for Reproductive Medicine, Practice Committee of the Society for Assisted Reproductive Technology, and Practice Committee of the Society of Reproductive Biologists and Technologists. Electronic address: asrm@asrm.org. Minimum standards for practices offering assisted reproductive technologies: a committee opinion. Fertil Steril. 2021 Mar;115(3):578-582. doi: 10.1016/j.fertnstert.2020.12.036. Epub 2021 Feb 7.

  PMID: 33568271 BACKGROUND

• West CP, Dyrbye LN, Shanafelt TD. Physician burnout: contributors, consequences and solutions. J Intern Med. 2018 Jun;283(6):516-529. doi: 10.1111/joim.12752. Epub 2018 Mar 24.

  PMID: 29505159 BACKGROUND

• Dyrbye et al. 2018. A Pragmatic Approach for Organizations to Measure Health Care Professional Well-Being. NAM Perspectives. Discussion Paper, National Academy of Medicine, Washington, DC. https://doi.org/10.31478/201810b

  BACKGROUND

• Frone MR, Tidwell MO. The meaning and measurement of work fatigue: Development and evaluation of the Three-Dimensional Work Fatigue Inventory (3D-WFI). J Occup Health Psychol. 2015 Jul;20(3):273-288. doi: 10.1037/a0038700. Epub 2015 Jan 19.

  PMID: 25602275 BACKGROUND

• Shanafelt TD, West CP, Sinsky C, Trockel M, Tutty M, Satele DV, Carlasare LE, Dyrbye LN. Changes in Burnout and Satisfaction With Work-Life Integration in Physicians and the General US Working Population Between 2011 and 2017. Mayo Clin Proc. 2019 Sep;94(9):1681-1694. doi: 10.1016/j.mayocp.2018.10.023. Epub 2019 Feb 22.

  PMID: 30803733 BACKGROUND

• Trockel MT, Menon NK, Rowe SG, Stewart MT, Smith R, Lu M, Kim PK, Quinn MA, Lawrence E, Marchalik D, Farley H, Normand P, Felder M, Dudley JC, Shanafelt TD. Assessment of Physician Sleep and Wellness, Burnout, and Clinically Significant Medical Errors. JAMA Netw Open. 2020 Dec 1;3(12):e2028111. doi: 10.1001/jamanetworkopen.2020.28111.

  PMID: 33284339 BACKGROUND

• Caruso CC, Baldwin CM, Berger A, Chasens ER, Edmonson JC, Gobel BH, Landis CA, Patrician PA, Redeker NS, Scott LD, Todero C, Trinkoff A, Tucker S. Policy brief: Nurse fatigue, sleep, and health, and ensuring patient and public safety. Nurs Outlook. 2019 Sep-Oct;67(5):615-619. doi: 10.1016/j.outlook.2019.08.004. No abstract available.

  PMID: 31582105 BACKGROUND

• Dyrbye LN, Shanafelt TD, Johnson PO, Johnson LA, Satele D, West CP. A cross-sectional study exploring the relationship between burnout, absenteeism, and job performance among American nurses. BMC Nurs. 2019 Nov 21;18:57. doi: 10.1186/s12912-019-0382-7. eCollection 2019.

  PMID: 31768129 BACKGROUND

• Letterie G, Fox D. Lawsuit frequency and claims basis over lost, damaged, and destroyed frozen embryos over a 10-year period. F S Rep. 2020 Jul 9;1(2):78-82. doi: 10.1016/j.xfre.2020.06.007. eCollection 2020 Sep.

  PMID: 34223222 BACKGROUND

• Moutos CP, Lahham R, Phelps JY. Cryostorage failures: a medicolegal review. J Assist Reprod Genet. 2019 Jun;36(6):1041-1048. doi: 10.1007/s10815-019-01478-x. Epub 2019 May 24.

  PMID: 31127476 BACKGROUND

• Murphy A, Lapczynski MS, Proctor G Jr, Glynn TR, Domar AD, Gameiro S, Palmer GA, Collins MG. Comparison of embryologist stress, somatization, and burnout reported by embryologists working in UK HFEA-licensed ART/IVF clinics and USA ART/IVF clinics. Hum Reprod. 2024 Oct 1;39(10):2297-2304. doi: 10.1093/humrep/deae191.

  PMID: 39198005 DERIVED

MeSH Terms

Conditions

Fatigue; Burnout, Professional; Musculoskeletal Pain; Back Pain; Neck Pain; Headache; Dizziness; Parasomnias; Chest Pain; Syncope; Cardiovascular Diseases; Dyspnea; Gastrointestinal Diseases; Burnout, Psychological

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Occupational Stress; Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Sensation Disorders; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Digestive System Diseases

Study Officials

• Anar Murphy, PhD

  TMRW Life Sciences

  PRINCIPAL INVESTIGATOR

• Michael Collins, PhD

  TMRW Life Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 14, 2022
• Study Start: April 7, 2022
• Primary Completion: April 25, 2022
• Study Completion: May 30, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)