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Spikes-focused bad news protocol for Infertility

N/A
Waitlist Available
Led By Alice Domar, PhD
Research Sponsored by Boston IVF
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 48 hours of phone call
Awards & highlights

Study Summary

This study is evaluating whether the SPIKES protocol is perceived to be more compassionate and effective than the current standard of care for IVF patients receiving negative pregnancy test results.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 48 hours of phone call
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 48 hours of phone call for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess if the SPIKES-based nursing script is associated with a difference in perceived nursing compassion
Assess patient depression after receiving the negative pregnancy test phone call
Assess patient distress after receiving the negative pregnancy test phone call

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SPIKES Protocol Compassionate CallExperimental Treatment1 Intervention
Nurses trained to contact IVF patients with negative pregnancy test results who were trained on the SPIKES-focused bad news delivery script.
Group II: Control: Standard of Care CallActive Control1 Intervention
Nurses who will continue to deliver bad news as they have been in the past without a script.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spikes-focused bad news protocol
2021
N/A
~140

Find a Location

Who is running the clinical trial?

Boston IVFLead Sponsor
19 Previous Clinical Trials
20,088 Total Patients Enrolled
18 Trials studying Infertility
19,788 Patients Enrolled for Infertility
Weill Medical College of Cornell UniversityOTHER
1,054 Previous Clinical Trials
1,316,392 Total Patients Enrolled
24 Trials studying Infertility
8,497 Patients Enrolled for Infertility
Alice Domar, PhDPrincipal InvestigatorBoston IVF
3 Previous Clinical Trials
1,887 Total Patients Enrolled
3 Trials studying Infertility
1,887 Patients Enrolled for Infertility

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
The Impact of the SPIKES Protocol With IVF Patients
Alice Domar 2021. "The Impact of the SPIKES Protocol With IVF Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04917445.
~35 spots leftby Apr 2025
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