Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06587360

fertiShare Evaluation

Led by Cardiff University · Updated on 2025-07-29

420

Participants Needed

5

Research Sites

72 weeks

Total Duration

On this page

Sponsors

C

Cardiff University

Lead Sponsor

W

Wales Fertility Institute, Swansea Bay University Healthboard, Wales, UK

Collaborating Sponsor

AI-Summary

What this Trial Is About

Sharing bad news (SBN) is a daily challenge for fertility staff and patients. Bad news happens at all stages of fertility care and includes e.g., diagnosing infertility, reporting unexpected, repeated, or definitive treatment failure. Extensive evidence shows that SBN triggers stress in staff due to anticipation of negative emotions and evaluations or, in extreme cases, even complaints and lawsuits. Inability to manage bad news can increase negative emotions in patients and fuel distrust, potentially leading to treatment discontinuation. Efficient SBN training exists but does not address challenges of SBN in fertility care, does not meet fertility staff training and patient care preferences, and its impact on patients is unclear. fertiShare is a brief, evidence-based, e-Learning SBN course bespoke for fertility care. The aim of the study is to evaluate the feasibility of implementing fertiShare at fertility clinics and of implementing an online multi-centre RCT to determine fertiShare's efficacy. This will allow to conclude if fertiShare should proceed to efficacy evaluation. An international interdisciplinary stakeholder group (patients, consultants, embryologists, nurses, psychologists, digital educators) will inform all aspects of the proposed project.

CONDITIONS

Official Title

fertiShare Evaluation

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

Fertility Healthcare Professionals' inclusion criteria are:

  • working at participating clinics; and
  • whose role involves a minimum of 10% of week time (half a day) SBN or being a non-clinical decision-maker (e.g., clinic/line managers).

Patients' inclusion criteria are

• adult individuals or couples attending participating clinics to discuss or undergo (in)fertility diagnosis or treatment with participating FHPs.

Exclusion criteria are:

  • not being able to read, speak or understand English;
  • not being able to provide consent.
  • for FHPs only, being unable to undergo the fertiShare training (e.g., visual impairments).

We will not be targeting groups or individuals deemed vulnerable. Potential participants are explicitly informed in the information sheet that, if they are worried about their mental health or psychological wellbeing they may chose not to participate at all. They are also advised to inform their fertility team and contact their GP in the usual way or the NHS Mental Health support service, www.nhs.yj/mental-health.

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 5 locations

1

Aberdeen Fertility Centre

Aberdeen, Aberdeen, United Kingdom, AB25 2ZL

Not Yet Recruiting

2

King's Fertility

London, London, United Kingdom, SE5 8BB

Actively Recruiting

3

Saint Mary's Hospital Manchester, Manchester University NHS Foundation Trust

Manchester, Manchester, United Kingdom, M13 9WU

Actively Recruiting

4

The Newcastle Upon Tyne Hospitals Nhs Foundation Trust

Newcastle, Newcastle upon Tyne, United Kingdom, NE3 3HD

Actively Recruiting

5

Wales Fertility Institute

Port Talbot, Port Talbot, United Kingdom, SA12 7BR

Not Yet Recruiting

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Research Team

S

Sofia Gameiro, PhD

CONTACT

J

Jacky Boivin, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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