Infertility Assisted Reproductive TechnologyNCT06587360
fertiShare Evaluation
A study testing fertiShare intervention - sharing bad news eLearning course in people with Infertility Assisted Reproductive Technology, run by Cardiff University at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infertility Assisted Reproductive Technology
- What is being tested?
- fertiShare intervention - sharing bad news eLearning course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 8 Oct 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jacky Boivin, PhD contact
5 sites in 1 country
United Kingdom5 sites, 5 recruiting
- Not yet recruiting
Aberdeen Fertility Centre
Aberdeen, Aberdeen, AB25 2ZL
Abha Maheshwari, abha.maheshwari@nhs.scot
- Recruiting
King's Fertility
London, London, SE5 8BB
Ippokratis Sarris, Ippokratis.Sarris@kingsfertility.co.uk
- Recruiting
Saint Mary's Hospital Manchester, Manchester University NHS Foundation Trust
Manchester, Manchester, M13 9WU
Raj Mathur, Raj.Mathur@mft.nhs.uk
- Recruiting
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
Newcastle, Newcastle upon Tyne, NE3 3HD
Meenakshi Choudhary, Dr, meenakshi.choudhary@nhs.net
- Not yet recruiting
Wales Fertility Institute
Port Talbot, Port Talbot, SA12 7BR
Francesca Steyn, francesca.steyn@wales.nhs.uk
About this study
Official title: Protocol for a Realist Evaluation and Feasibility RCT: Understanding and Developing a SPIKES-based eLearning Training Course Called fertiShare to Support Sharing Bad News Encounters Between Fertility Healthcare Professionals (FHPs) and Patients
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.
Read the detailed description
The aim of the feasibility study is to make a fully informed decision about whether fertiShare should proceed to efficacy evaluation. This aim will be achieved by resolving uncertainties about implementing fertiShare at fertility clinics and about running an online multi-centre efficacy RCT for fertiShare.
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%.
- Being tested
- fertiShare intervention - sharing bad news eLearning course, fertiShare control - basic communication skills eLearning course
- Keywords
- sharing bad news, healthcare communication, assisted reproduction, infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fertiShare intervention - sharing bad news eLearning courseOther
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 courseOther
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).
| Study group | Role | What they receive |
|---|---|---|
| fertiShare intervention | Experimental | sharing bad news eLearning course Receives: Other: fertiShare intervention - sharing bad news eLearning course |
| fertiShare control | Active comparator | basic communication training skills eLearning course Receives: Other: fertiShare control - basic communication skills eLearning course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limited Efficacy Testing: changes from baseline in patients perceived FHPs' sharing bad news performance (primary outcome)
Modified intention-to-treat (mITT, all FHPs randomized) and per protocol (PP, only FHPs who completed a sufficient dose) analyses of mean differences in patient reported FHPs' sharing bad news performance (primary outcome) between patients in the baseline (pre FHPs training) and follow-up (post FHPs training) cohort. Patient reported FHPs' sharing bad news performance will be assessed with an adapted version of the Sharing Bad News Behavioural Assessment Scale. The scale is composed of 23 items that list evidence-based best practice behaviours on how to share bad news (e.g., warn you they would be sharing bad news). Patients are asked to rate the degree to which the FHP did each behaviour on a Likert scale from 1- not at all to 5 - completely (or 6 - does not apply). A global average score is calculated that ranges from 1 to 5, with higher values indicating better sharing bad news performance.
Measured: Within one week of enrolment in the study
Secondary outcomes (5)
Limited Efficacy Testing: changes from baseline in staff confidence in sharing bad news (secondary outcome)
Modified intention-to-treat (mITT, all FHPs randomized) and per protocol (PP, only FHPs who completed a sufficient dose) analyses of changes in confidence in SBN (secondary outcome) from pre to post training with fertiShare or control eLearning. Confidence in sharing bad news will be assessed with an adapted version of the Breaking Bad News Assessment Scale. The scale is composed of 23 items that list evidence-based best practice behaviours on how to share bad news (e.g., warn patients you will be sharing bad news). FHPs are asked to rate how confident they feel doing each behaviour listed on a Likert scale from 1- not at all to 5 - completely (or 6 - does not apply). A global average score is calculated that ranges from 1 to 5, with higher values indicating higher confidence in sharing bad news.
Measured: From two weeks after enrolment to two weeks after training (fertiShare, control), which happens 5 months from enrolment
Limited Efficacy Testing: mean difference in patient trust in their Fertility Healthcare Professional (FHP) between the baseline and follow-up patient cohorts (secondary outcome)
Modified intention-to-treat (mITT, all FHPs randomized) and per protocol (PP, only FHPs who completed a sufficient dose) analyses of mean differences in patient trust in their FHP (secondary outcome) between patients in the baseline and follow-up cohort. Trust will be assessed with the Wake Forest Physician Trust Scale. The scale is composed of ten statements describing care provided (e.g., They will do whatever it takes to get you all the care you need.). Patients are asked to rate their level of agreement with each statement on a Likert scale from 1- strongly disagree to 5-strongly agree. Trust is measured by the sum of the 10 item scores (reverse-scored for negative items), ranging from 10 to 50, with a higher score indicating more trust.
Measured: Within one week of enrolment in the study
Limited Efficacy Testing: mean difference in patients' satisfaction with care at the clinic (secondary outcome) between the baseline and follow-up patient cohorts
Modified intention-to-treat (mITT, all FHPs randomized) and per protocol (PP, only FHPs who completed a sufficient dose) analyses of mean differences in patient satisfaction with care at the clinic (secondary outcome) between patients in the baseline and follow-up cohort. Assessed with five questions used by the Human Fertility and Embryology Authority for patients to rate their satisfaction with care provided at UK based fertility clinics (e.g., To what extent did you feel you were treated with privacy and dignity?). Patients answer on a Likert scale from 1-never to 5-always (answer scale anchors vary with question), with higher values indicating higher satisfaction with care.
Measured: Within one week of enrolment in the study
Limited Efficacy Testing: mean difference in patients' satisfaction with shared decision-making support regarding continuing or stopping fertility treatment (secondary outcome) between the baseline and follow-up patient cohorts (secondary outcome)
Modified intention-to-treat (mITT, all FHPs randomized) and per protocol (PP, only FHPs who completed a sufficient dose) analyses of mean differences in patient satisfaction with shared decision-making support about continuing fertility treatment (secondary outcome) between patients in the baseline and follow-up cohort. Assessed with the Decisional Conflict Scale. Patients are asked to select which treatment option they prefer (doing another treatment cycle at clinic, doing another treatment cycle at a different clinic, stopping fertility treatment, other) and to rate the degree to which they agree with a list of 16 statements related to their decision (e.g., I know which options are available to me) on a Likert scale from 0-strongly agree to 4-strongly disagree. Total decisional conflict and sub-dimension scores (uncertainty, informed, values clarity, support) are calculated and linearly transformed to range from 0 to 100, with higher scores indicating more of the construct.
Measured: Within one week of enrolment in the study
Limited Efficacy Testing: mean difference in patients' uptake of and time to another stimulated In Vitro Fertilisation Cycle between the baseline and follow-up patients cohorts (secondary outcome)
Modified intention-to-treat (mITT, all staff randomized) and per protocol (PP, only staff who completed a sufficient dose) analysis of mean differences in patient uptake of (yes, no, not recommended) and time to another stimulated IVF cycle (in days, not applicable) between patients in the baseline and follow-up cohort: data obtained via patient record review.
Measured: 6 months and 2 weeks after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start8 Oct 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Infertility Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiff University
- Sponsor type
- University, hospital or other
- Collaborators
- Wales Fertility Institute, Swansea Bay University Healthboard, Wales, UK, Dept of Health Sciences, Milan University, Milan, Italy
- Responsible party
- Principal investigator, Sofia Gameiro, Cardiff University
- Investigators
- Sofia Gameiro, PhD, Principal investigator, Cardiff UniversityHelen Falconer, Study chair, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587360
- Sponsor's protocol ID
- SPON1955-23
- Status last verified
- Dec 2024
- First submitted
- 29 Aug 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be submitted for publication. We will make the study data open on the Open Science Framework (with the participants' consent). This is an academic resource that makes data available for secondary analysis by other researchers and provides assurance of for science integrity and reproducibility.
Publications
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.
PubMed 37968233Yilmaz 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.
PubMed 34039344Miller 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.
PubMed 10360657Hall 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.
PubMed 12205830Axboe 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.
PubMed 27756291Gameiro 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.
PubMed 40854842
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Realist Evaluation and Feasibility RCT: Understanding and Developing a SPIKES-based eLearning Training Course Called fertiShare to Support Sharing Bad News Encounters Between Fertility Healthcare Professionals (FHPs) and Patients
- ClinicalTrials.gov ID
- NCT06587360
- Acronym / sponsor ID
- SPON1955-23
- Keywords
- sharing bad news, healthcare communication, assisted reproduction, infertility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Cardiff UniversityUniversity, hospital or other
- Collaborators
- Wales Fertility Institute, Swansea Bay University Healthboard, Wales, UK, Dept of Health Sciences, Milan University, Milan, Italy
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of the feasibility study is to make a fully informed decision about whether fertiShare should proceed to efficacy evaluation. This aim will be achieved by resolving uncertainties about implementing fertiShare at fertility clinics and about running an online multi-centre efficacy RCT for fertiShare.
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%.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fertiShare intervention | Experimental | Other: fertiShare intervention - sharing bad news eLearning coursesharing bad news eLearning course |
| fertiShare control | Active comparator | Other: fertiShare control - basic communication skills eLearning coursebasic communication training skills eLearning course |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fertiShare intervention - sharing bad news eLearning coursetwo-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. | Other | fertiShare intervention |
| fertiShare control - basic communication skills eLearning courseself-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). | Other | fertiShare control |
Primary outcome
Limited Efficacy Testing: changes from baseline in patients perceived FHPs' sharing bad news performance (primary outcome)
Time frame: Within one week of enrolment in the study
Modified intention-to-treat (mITT, all FHPs randomized) and per protocol (PP, only FHPs who completed a sufficient dose) analyses of mean differences in patient reported FHPs' sharing bad news performance (primary outcome) between patients in the baseline (pre FHPs training) and follow-up (post FHPs training) cohort. Patient reported FHPs' sharing bad news performance will be assessed with an adapted version of the Sharing Bad News Behavioural Assessment Scale. The scale is composed of 23 items that list evidence-based best practice behaviours on how to share bad news (e.g., warn you they would be sharing bad news). Patients are asked to rate the degree to which the FHP did each behaviour on a Likert scale from 1- not at all to 5 - completely (or 6 - does not apply). A global average score is calculated that ranges from 1 to 5, with higher values indicating better sharing bad news performance.
5 secondary outcomes
Limited Efficacy Testing: changes from baseline in staff confidence in sharing bad news (secondary outcome)
Time frame: From two weeks after enrolment to two weeks after training (fertiShare, control), which happens 5 months from enrolment
Limited Efficacy Testing: mean difference in patient trust in their Fertility Healthcare Professional (FHP) between the baseline and follow-up patient cohorts (secondary outcome)
Time frame: Within one week of enrolment in the study
Limited Efficacy Testing: mean difference in patients' satisfaction with care at the clinic (secondary outcome) between the baseline and follow-up patient cohorts
Time frame: Within one week of enrolment in the study
Limited Efficacy Testing: mean difference in patients' satisfaction with shared decision-making support regarding continuing or stopping fertility treatment (secondary outcome) between the baseline and follow-up patient cohorts (secondary outcome)
Time frame: Within one week of enrolment in the study
Limited Efficacy Testing: mean difference in patients' uptake of and time to another stimulated In Vitro Fertilisation Cycle between the baseline and follow-up patients cohorts (secondary outcome)
Time frame: 6 months and 2 weeks after enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Background: PubMed 37968233Gameiro 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.
- Background: PubMed 34039344Yilmaz 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.
- Background: PubMed 10360657Miller 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.
- Background: PubMed 12205830Hall 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.
- Background: PubMed 27756291Axboe 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.
- Derived from this study: PubMed 40854842Gameiro 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.
- Individual participant dataSharing planned: Yes. The study protocol will be submitted for publication. We will make the study data open on the Open Science Framework (with the participants' consent). This is an academic resource that makes data available for secondary analysis by other researchers and provides assurance of for science integrity and reproducibility.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacky Boivin, PhD contact
Sofia Gameiro, PhD principal investigator
Cardiff University
Helen Falconer study chair
Cardiff University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fertiShare intervention - sharing bad news eLearning course in people with Infertility Assisted Reproductive Technology, run by Cardiff University at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofia Gameiro, PhD (+44 (0)29 2087 5376, gameiros@cardiff.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limited Efficacy Testing: changes from baseline in patients perceived FHPs' sharing bad news performance (primary outcome) (time frame: Within one week of enrolment in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06587360, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025; AzTrials last refreshed its copy on 27 Oct 2026.