Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
420 participants
INTERVENTIONAL
2024-10-08
2026-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Implementing a Pilot Patient Navigator Program to Improve Access to Infertility Care for Underserved Patients
NCT06481319
The Effect of Fertility Health Awareness Strategies on Fertility Knowledge and Childbearing in Young Married Couples
NCT04647136
Testing a New Self-help Intervention for Infertility Related Distress: a Pilot Study
NCT05103982
Impact Evaluation of the "Baby Newsletter"
NCT03268408
Testing an Evidence-Based Self-Help Program for Infertility-Related Distress in Women
NCT06006936
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Design: Pre-registered, online, multi-centre, two-arm, triple-blinded (staff, patients, data analysts), feasibility RCT with 1:1 computer-generated randomized allocation to the intervention (fertiShare) or minimal SBN information control (20 mins SBN lecture emulating what most staff would receive as part of general training) groups.
The trial will include a process evaluation and adopt a pragmatic attitude to maximise the applicability of findings to fertility care practice (beyond the immediate trial setting). Examples of design choices that translate this pragmatic attitude are our choice of the control condition (emulating general SBN training that most staff will have), the inclusion of multiple staff and patient secondary trial outcomes (informed by stakeholders) and low standardisation of intervention delivery (staff will apply fertiShare as they think best). Criteria for progression to efficacy evaluation will be specified prior to implementation using a traffic-light system.
Setting: Six UK-based private and public fertility clinics.
Participants: Staff working at clinics whose role involves 10% of week time SBN. Exclusion criteria are being unable to undergo training.
Patient inclusion criteria are having received bad news from participating staff within last month. No exclusion criteria are applied.
Bad news is defined as any news meaning that patients\' first or second complete (fresh and frozen embryo transfers) initiated In Vitro Fertilization cycle did not result in a clinical pregnancy, as this is the most common challenging bad news shared by staff, and to ensure that patient outcome data (specifically continuation data) are comparable.
Guidance for feasibility studies to estimate participation rates, based on review of evidence from RCTs conducted within SBN training and fertility care, indicates 75% of staff will be eligible and participate, but a conservative estimate of 50% will be considered to decrease unknown risk. Recruiting 60 staff (10 per clinic) will allow to calculate a 50% participation rate to 95%CI of ±11%. 52% of patients will be eligible and participate. Recruiting 180 patients per cohort (30 per clinic) will allow to calculate a 60% participation rate to 95%CI of ±6%.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
fertiShare intervention
sharing bad news eLearning course
fertiShare intervention - sharing bad news eLearning course
two-hour self-led eLearning course to support fertility staff in sharing bad news (SBN) with their patients
organised in three modules. Module 1 explores definitions of bad news, why it is challenging to FHPs and patients, and the benefits of training. Module 2 offers SPIKES-based step-by-step guidance to ease SBNs. Module 3 offers guidance to cope with common challenges FHPs face: sharing bad news remotely, managing anger and uncertainty, and using good news to lessen the impact of bad news.
Each module offers video content-based lessons, case studies that illustrate guidance and brief quizzes for self-reflection and assessment. Case studies show learners optimal and suboptimal approaches to SBN.
fertiShare control
basic communication training skills eLearning course
fertiShare control - basic communication skills eLearning course
self-led eLearning course branded as fertiShare but designed to emulate the basic communication training healthcare providers receive as they undergo their professional degrees.
organised in three modules. Module 1 explores definitions of bad news, why it is challenging to FHPs and patients, and the benefits of training. Module 2 introduces the communication cycle and associated communication techniques. Module 3 offers guidance regarding other basic communication skills: empathic communication, non-verbal communication, active listening and remote consultations, and communicating the likelihood of positive or negative treatment outcomes.
Each module offers video content-based lessons, case studies, and brief quizzes. All teaching elements remain at the basic level (remembering and understanding instead of analysing and applying).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
fertiShare intervention - sharing bad news eLearning course
two-hour self-led eLearning course to support fertility staff in sharing bad news (SBN) with their patients
organised in three modules. Module 1 explores definitions of bad news, why it is challenging to FHPs and patients, and the benefits of training. Module 2 offers SPIKES-based step-by-step guidance to ease SBNs. Module 3 offers guidance to cope with common challenges FHPs face: sharing bad news remotely, managing anger and uncertainty, and using good news to lessen the impact of bad news.
Each module offers video content-based lessons, case studies that illustrate guidance and brief quizzes for self-reflection and assessment. Case studies show learners optimal and suboptimal approaches to SBN.
fertiShare control - basic communication skills eLearning course
self-led eLearning course branded as fertiShare but designed to emulate the basic communication training healthcare providers receive as they undergo their professional degrees.
organised in three modules. Module 1 explores definitions of bad news, why it is challenging to FHPs and patients, and the benefits of training. Module 2 introduces the communication cycle and associated communication techniques. Module 3 offers guidance regarding other basic communication skills: empathic communication, non-verbal communication, active listening and remote consultations, and communicating the likelihood of positive or negative treatment outcomes.
Each module offers video content-based lessons, case studies, and brief quizzes. All teaching elements remain at the basic level (remembering and understanding instead of analysing and applying).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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).
• adult individuals or couples attending participating clinics to discuss or undergo (in)fertility diagnosis or treatment with participating FHPs.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wales Fertility Institute, Swansea Bay University Healthboard, Wales, UK
UNKNOWN
Dept of Health Sciences, Milan University, Milan, Italy
UNKNOWN
Cardiff University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sofia Gameiro
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sofia Gameiro, PhD
Role: PRINCIPAL_INVESTIGATOR
Cardiff University
Helen Falconer
Role: STUDY_CHAIR
Cardiff University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aberdeen Fertility Centre
Aberdeen, Aberdeen, United Kingdom
King's Fertility
London, London, United Kingdom
Saint Mary's Hospital Manchester, Manchester University NHS Foundation Trust
Manchester, Manchester, United Kingdom
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
Newcastle, Newcastle upon Tyne, United Kingdom
Wales Fertility Institute
Port Talbot, Port Talbot, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Gameiro S, Adcock E, Graterol Munoz C, O'Hanrahan M, D'Angelo A, Boivin J. What is bad news in fertility care? A qualitative analysis of staff and patients' accounts of bad and challenging news in fertility care. Hum Reprod. 2024 Jan 5;39(1):139-146. doi: 10.1093/humrep/dead231.
Yilmaz Y, Sarikaya O, Senol Y, Baykan Z, Karaca O, Demiral Yilmaz N, Altintas L, Onan A, Sayek I. RE-AIMing COVID-19 online learning for medical students: a massive open online course evaluation. BMC Med Educ. 2021 May 27;21(1):303. doi: 10.1186/s12909-021-02751-3.
Miller SJ, Hope T, Talbot DC. The development of a structured rating schedule (the BAS) to assess skills in breaking bad news. Br J Cancer. 1999 May;80(5-6):792-800. doi: 10.1038/sj.bjc.6690423.
Hall MA, Zheng B, Dugan E, Camacho F, Kidd KE, Mishra A, Balkrishnan R. Measuring patients' trust in their primary care providers. Med Care Res Rev. 2002 Sep;59(3):293-318. doi: 10.1177/1077558702059003004.
Axboe MK, Christensen KS, Kofoed PE, Ammentorp J. Development and validation of a self-efficacy questionnaire (SE-12) measuring the clinical communication skills of health care professionals. BMC Med Educ. 2016 Oct 18;16(1):272. doi: 10.1186/s12909-016-0798-7.
Gameiro S, Leone D, D'Angelo A, Veleva Z, Morey R, Boivin J. Multicentre pragmatic randomised controlled feasibility trial of fertiShare, a brief eLearning course to increase fertility staff performance when sharing bad news with their patients - a protocol. BMJ Open. 2025 Aug 25;15(8):e101269. doi: 10.1136/bmjopen-2025-101269.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPON1955-23
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.