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NCT04917445 · ClinicalTrials.gov registry record · NA

The Impact of the SPIKES Protocol With IVF Patients

A NA study, sponsored by Boston IVF.

Completed
Registry status
NA
Development phase
136
Enrollment target

NCT04917445: Completed NA study, sponsored by Boston IVF.

NCT04917445 is a NA study that has completed, run by Boston IVF. The registered enrollment target is 136 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04917445, a NA study, has completed, sponsored by Boston IVF.

COMPLETED
Registry status
NA
Development phase
136 participants
Enrollment target

Study Summary

The purpose of this study is to determine if the utilization of the SPIKES protocol for delivering bad news is perceived to be more compassionate and effective than the current standard of care for IVF patients receiving negative pregnancy test results.

Primary Outcome

We revised the Communicating Bad News questionnaire which follows the SPIKES protocol, published by Gonzales-Cabrera et al. Their questionnaire had 25 items, Internal consistency was 0.816. The content validity was established via the Kaiser-Meyer-Olkin test (KMO) with a score of 0.683 and the Bartlett test of sphericity was p\<0.001. The principal component analysis supported a four dimension construct. There are 22 items rated 1, 2, 3 with a scoring range of 22-66. For the Compassion Assessmen

Interventions

  • BEHAVIORAL Spikes-focused bad news protocol

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2021-06-17
Est. Completion 2022-05-24
Phase NA
Boston IVF

10 total trials

What the finished NCT04917445 record still lists

NCT04917445 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which Spikes-focused bad news protocol is the first listed.

NCT04917445 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04917445 about?

NCT04917445 is a clinical study titled "The Impact of the SPIKES Protocol With IVF Patients". The purpose of this study is to determine if the utilization of the SPIKES protocol for delivering bad news is perceived to be more compassionate and effective than the current standard of care for IVF patients receiving negative pregnancy test results.

What is the current status of trial NCT04917445?

This trial is currently completed. It is a NA study. The enrollment target is 136 participants. The study started on 2021-06-17. Estimated completion is 2022-05-24.

What interventions are being tested in trial NCT04917445?

The interventions under investigation include: Spikes-focused bad news protocol (BEHAVIORAL).

Who is sponsoring clinical trial NCT04917445?

This trial is sponsored by Boston IVF, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04917445's enrollment target sits among peer trials

136 722nd of 2000 higher than 1,275 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04917445, the US trial registry maintained by the National Library of Medicine. NCT04917445 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.