| NCT ID | NCT06587360 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cardiff University |
| Condition | Infertility Assisted Reproductive Technology |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2024-10-08 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 420 participants in total. It began in 2024-10-08 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Sofia Gameiro, PhD
PRINCIPAL INVESTIGATOR
Cardiff University
Frequently Asked Questions
Who can join the NCT06587360 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Infertility Assisted Reproductive Technology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06587360 currently recruiting?
Yes, NCT06587360 is actively recruiting participants. Contact the research team at gameiros@cardiff.ac.uk for enrollment information.
Where is the NCT06587360 trial being conducted?
This trial is being conducted at Aberdeen, United Kingdom, London, United Kingdom, Manchester, United Kingdom, Newcastle, United Kingdom and 1 additional location.
Who is sponsoring the NCT06587360 clinical trial?
NCT06587360 is sponsored by Cardiff University. The principal investigator is Sofia Gameiro, PhD at Cardiff University. The trial plans to enroll 420 participants.