The U.K. Embryologist Fatigue Study

NCT ID: NCT05708963

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-16

Study Completion Date

2023-02-02

Brief Summary

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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

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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.

Conditions

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Fatigue Stress Burnout, Professional Musculoskeletal Pain Back Pain Neck Pain Headache Dizziness Sleep Disturbance Chest Pain Syncope Cardiovascular Diseases Shortness of Breath Gastrointestinal Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* complete surveys from embryologists

Exclusion Criteria

* incomplete surveys from embryologists; complete and incomplete surveys from non-embryologists.
Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dudley Associates Healthcare Marketing & Communications

UNKNOWN

Sponsor Role collaborator

TMRW Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anar Murphy, PhD

Role: PRINCIPAL_INVESTIGATOR

TMRW Life Sciences

Locations

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TMRW Life Sciences

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25284212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30001832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33459106 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29505159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25602275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30803733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33284339 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31582105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31768129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34223222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31127476 (View on PubMed)

Boivin J, Bunting L, Koert E, Ieng U C, Verhaak C. Perceived challenges of working in a fertility clinic: a qualitative analysis of work stressors and difficulties working with patients. Hum Reprod. 2017 Feb;32(2):403-408. doi: 10.1093/humrep/dew326. Epub 2017 Jan 5.

Reference Type BACKGROUND
PMID: 28057875 (View on PubMed)

Applebaum J, Humphries LA, Nepps ME, Berger DS, O'Neill K. Malpractice litigation surrounding in vitro fertilization in the United States: a legal literature review. Fertil Steril. 2023 Apr;119(4):572-580. doi: 10.1016/j.fertnstert.2022.12.038. Epub 2022 Dec 27.

Reference Type BACKGROUND
PMID: 36581015 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39198005 (View on PubMed)

Related Links

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https://www.hfea.gov.uk/about-us/publications/research-and-data/fertility-treatment-2019-trends-and-figures/

The Human Fertilisation \& Embryology Authority. Fertility treatment 2019: trends and figures. UK statistics for IVF and DI treatment, storage, and donation. May 2021.

https://www.hfea.gov.uk/about-us/how-we-regulate/

The Human Fertilisation \& Embryology Authority. How we regulate

https://www.hfea.gov.uk/about-us/publications/research-and-data/state-of-the-fertility-sector-2019-2020/

The Human Fertilisation \& Embryology Authority. State of the fertility sector 2019/2020. November 2020.

https://doi.org/10.1016/j.fertnstert.2022.08.205

Embryologist burnout: physical and psychological symptoms and occupational challenges currently reported by U.S. embryologists

https://doi.org/10.1016/j.fertnstert.2022.08.368

Working with fatigue: assessment of cryomanagement conditions in IVF biorepositories

https://nam.edu/a-pragmatic-approach-for-organizations-to-measure-health-care-professional-well-being/

A Pragmatic Approach for Organizations to Measure Health Care Professional Well-Being

Other Identifiers

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Pro00062375-2

Identifier Type: -

Identifier Source: org_study_id

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