Developing and Validating Fertilit-e: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Developing and Validating Fertilit-e (NCT03599661), a registered phase not stated study. The primary outcome is Evaluation of Fertilit-e Alpha - Usability (Number of Participants).

2. Clinical Question

In practical terms, the study is framed as an evaluation of a decision aid’s usability, rather than as a test of whether it changes a clinical outcome. The registry record also lists evaluation of Fertilit-e alpha comprehensibility as a secondary outcome. It does not provide a detailed account of how usability or comprehensibility is judged, what qualifies as successful use, or how interview observations are converted into the reported participant count. Those definitions are not reported in the registry record.

The record gives a primary-outcome timeframe of 6 months. It does not specify whether that timeframe describes recruitment, follow-up, or another schedule element. Accordingly, the research question can be described as a planned assessment of how young adults with cancer experience and understand Fertilit-e, but not as a fully specified comparison of outcomes across groups.

3. Trial Design

NCT03599661 is titled “Developing and Validating Fertilit-e” and is designated Aim 1 of a project to adapt and validate an eHealth fertility-preservation decision aid for young adults with cancer. Wake Forest University Health Sciences is listed as the sponsor. The registry records a start date of 2018-08-15, a primary completion date of 2022-06-07, enrollment of 21, and a terminated status.

The intervention description combines use of the decision aid with data collection. Participants review Fertilit-e content, are interviewed about content, functionality, and ease of use, and complete questionnaires in a session described as lasting 45-60 minutes. Interview and questionnaire administration are both listed as interventions, with each classified as “OTHER.” The primary-outcome description specifically refers to think aloud interviews and qualitative analysis.

The registry does not state the allocation method. It does not establish a randomized design, and its own comparison note says the arms are not a like-for-like control comparison. The described Fertilit-e activity should therefore be understood as a study activity, not automatically as one side of a controlled treatment contrast. Further details about recruitment, eligibility, setting, participant flow, and whether every enrolled participant completed every activity are not reported in the registry record.

The primary outcome is titled as a count of participants for alpha usability, with a timeframe of 6 months. The record lists three outcome measures and one secondary outcome concerning comprehensibility, but it reports zero analyses. It does not describe a statistical analysis plan, a prespecified sample-size justification, or interim analyses. The sample-size assumptions associated with planning illustrations are not evidence of the study’s original design or of an analysis actually performed.

These design details matter because the aim and data-collection activities are exploratory and evaluative. Without a stated allocation method or an appropriate control group, the record does not support interpreting the study as a comparative trial. Its stated focus is the evaluation and development of a decision aid, with usability and comprehensibility as central concerns.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: 21 participants were enrolled/consented. Nine participants were lost to follow up and no data was collected. Only 12 participants have data that was collected.

6. Primary Endpoint

The registry lists the primary outcome as Evaluation of Fertilit-e Alpha - Usability (Number of Participants), measured over 6 months.

The primary outcome is titled “Evaluation of Fertilit-e Alpha - Usability (Number of Participants)” and uses participants as its unit. Its description says usability is to be examined through think aloud interviews. In this type of activity, participants work through material while verbalizing their reactions or points of difficulty; that is a general description of the method, not a claim about additional procedures in this study. The registry says qualitative analysis will produce an integrative summary and identify key points, potential themes, and areas for further exploration.

A participant count can describe how many people contributed to an evaluation or met a stated criterion. However, the record does not define a usability threshold, specify what counts as an event for the count, or report the observed count. It also does not explain how the qualitative findings are linked to the participant-count outcome. The measure is therefore identifiable by its title and description, but its operational definition is incomplete in the registry record.

Usability evaluation is relevant to a decision aid because the intended audience needs to be able to engage with its content and functions. That is a general rationale, not evidence that Fertilit-e was easy or difficult to use. The listed timeframe is 6 months; the specific timing of the assessment within that period is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the primary measure represent? The primary outcome is described as a count of participants and is titled as an evaluation of alpha usability. A count is an absolute tally, not by itself a proportion, rate, score, or comparison between groups. To interpret a count, readers generally need to know the rule defining who is counted and the denominator of participants who could have met that rule. The registry record does not state a usability criterion, report the observed count, or give an analysis denominator. The outcome description instead emphasizes qualitative analysis of think aloud interviews.

Qualitative analysis and quantitative counts answer different kinds of questions. A qualitative summary can characterize recurring observations, identify themes, and describe issues participants raise. A count can convey how many participants meet a defined condition or contribute data. Neither form automatically substitutes for the other. The registry description names both an integrative qualitative summary and a participant-count endpoint, but does not explain how those outputs relate. That connection is not reported in the registry record.

What can a confidence interval tell a reader? In general, a confidence interval expresses the uncertainty around an estimated quantity under a specified statistical model and sampling process. A narrow interval indicates greater precision for that estimate, while a wide interval indicates less precision. It does not repair an unclear endpoint definition, remove bias from missing observations, or show that a result is clinically important. No confidence interval or other estimate for the primary outcome is reported in the registry record, so precision cannot be assessed for an observed usability result.

What would a statistical comparison require? In general, a comparative analysis needs a clearly defined contrast, outcome, analysis population, and method. When groups are intended to be comparable, the study design and allocation process help determine how cautiously differences can be interpreted. Here, allocation is not stated, and the registry warns that the arms are not a like-for-like control comparison. The record does not support treating the study as a randomized comparison or deriving a treatment effect. No analysis method for a comparative effect is reported.

How should the planning assumptions be read? The planning illustrations are described as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a stated fraction of the observed effect. The assumptions also distinguish total events for time-to-event calculations from participants per arm for other calculations. These are general planning conventions attached to the illustrations; they are not reported as the trial’s design or analysis plan. They do not mean that participants were assigned equally, that two comparable arms existed, or that an observed treatment effect was established. Sample-size calculations are planning illustrations, not observed power.

The record does not report an effect estimate from an analysis. It therefore does not give a basis for interpreting the planning assumptions as evidence about the precision or power of the study’s actual findings. A planned sample size can be informative only in relation to a specified outcome, target effect, variance or event model, and design. The registry record does not provide a sample-size justification for this study.

Why can over-dispersion matter? In general, over-dispersion occurs when count data vary more than a statistical model assumes. If a model understates that variation, standard errors may be too small and uncertainty may be understated. This concept is relevant to some count-data analyses, but the registry record does not report a fitted count model, a dispersion estimate, or an analysis of the primary participant count. It would be inappropriate to infer that over-dispersion was assessed or that a particular model was used.

What is the role of the interview method? Think aloud interviews can provide direct descriptions of participants’ reasoning and points of friction as they interact with material. As a general method, the resulting evidence depends on how the task is conducted, how comments are captured, how themes are developed, and whether more than one analyst reviews the material. The registry identifies think aloud interviews and qualitative analysis but does not report the interview guide, coding approach, analyst procedures, handling of disagreement, or criteria for deciding when data collection was sufficient. These methodological details are not reported in the registry record.

Questionnaire administration is listed as an intervention, and the arm description says participants complete questionnaires. However, the questionnaire instruments, scoring rules, and their relationship to the primary outcome are not reported in the registry record. The secondary outcome listed is evaluation of Fertilit-e alpha comprehensibility; no operational definition or analyzed result is given. Consequently, the methods described support understanding the general evaluation approach, but they do not permit reconstruction of a statistical analysis or assessment of its precision.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures and identifies usability as the primary outcome. It also lists evaluation of Fertilit-e alpha comprehensibility as a secondary outcome. The record does not explain how these measures are prioritized beyond the primary label, whether multiple versions or time points were assessed, or whether any adjustment for multiple testing was planned. A multiplicity strategy is not reported in the registry record.

Multiplicity matters when several outcomes or analyses are examined: the more opportunities there are to identify an apparently notable result, the more careful interpretation of chance findings becomes. This is a general statistical concern, not a claim that the study conducted multiple tests. The registry lists zero analyses, so no reported inferential testing or adjustment can be evaluated.

Missing-data procedures are not reported. The record does not describe how incomplete questionnaires, absent interview data, withdrawals, or participants with partially completed activities were handled. It also does not report participant flow from enrollment through analysis. Although enrollment is 21, the number contributing to each outcome cannot be determined from that figure alone.

The analysis population is likewise not reported in the registry record. There is no description of whether analyses were intended to include all enrolled participants, only those completing the session, or another defined group. No imputation method, sensitivity analysis, or rule for excluding unusable observations is reported. These omissions prevent assessment of how missing or incomplete data might affect an outcome estimate.

11. What the Result Does, and Does Not, Mean

The record establishes the purpose and broad approach of a usability evaluation: Fertilit-e content review, interviews about content, functionality, and ease of use, questionnaires, and planned qualitative analysis of think aloud interviews. It also records enrollment of 21 and a terminated status. These registry entries describe the study and its intended assessment, but do not establish what participants said or how they rated the tool.

No primary outcome result is reported in the registry record. There is no posted participant count for usability, no summary of interview themes, no comprehensibility result, and no statistical estimate with a measure of precision. As a result, the posted results do not show whether Fertilit-e met a usability standard or how consistently participants experienced its content and functions. The standard itself is not defined in the record.

The record also does not establish that the decision aid changed a clinical outcome or that it performed better than another approach. Allocation is not stated, and the listed arms are not a like-for-like control comparison. A development and validation aim is not the same as a controlled estimate of effect. No comparative conclusion can be drawn from the registry entries alone.

Likewise, the adverse-event entries do not support a safety conclusion: the recorded number at risk is zero, and participant-level event reporting cannot be interpreted from those entries as evidence about the experience of all enrolled participants. This distinction illustrates why a registry entry must be read in the context of its denominators and reported analysis population.

The narrow conclusion is that the registry documents an evaluation plan and study status, not analyzed findings. Further interpretation of usability, comprehensibility, precision, missing data, or safety would require results and methodological details that are not reported in the registry record.

12. Why This Trial Matters Statistically

Usability is a meaningful statistical and methodological issue for decision aids because an outcome measure is only informative if the intended users can engage with the tool and the evaluation captures that experience. This is a general point about measurement. The Fertilit-e record makes usability a primary focus and describes think aloud interviews, which can reveal where participants encounter questions or difficulties. It also identifies comprehensibility as a secondary outcome.

The record is useful for showing how an evaluation question can combine qualitative methods with a quantitative endpoint label. The primary outcome title specifies a participant count, while its description emphasizes qualitative summaries and themes. That combination raises an important measurement question: what exactly is counted, and how does the count relate to the qualitative findings? The registry does not answer that question. Clear operational definitions help readers understand what an endpoint represents and whether it can be reproduced.

This study also illustrates why enrollment, completion, and analysis are distinct concepts. The record lists enrollment of 21, but does not report outcome denominators or analyses. An enrolled participant is not necessarily an analyzable observation for every endpoint. Reporting participant flow and missing-data handling would help readers judge which experiences informed any conclusion.

Finally, a study’s registry status and planned methods should not be mistaken for findings. Terminated status and a stated development aim do not reveal why the study ended or what the evaluation showed; the reason for termination is not reported in the registry record. The absence of posted analyses limits conclusions, but the registered question still highlights practical statistical considerations: define the construct, specify how observations become outcomes, report uncertainty where estimates are made, and distinguish exploratory evidence from comparative inference.

13. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main limitation for interpretation is the absence of posted outcome analyses. The registry gives no observed usability count, qualitative summary, comprehensibility result, or estimate of uncertainty. The primary-outcome description does not define the criterion for counting a participant, leaving the endpoint’s operational meaning unclear. The connection between the qualitative analysis and the participant-count outcome is also not described.

Design and participant-flow details are limited. Allocation is not stated, the record says the arms are not a like-for-like control comparison, and the number contributing data to each outcome is not reported. The enrollment figure alone cannot establish completion or an analysis denominator. Eligibility criteria, recruitment details, questionnaire instruments, interview procedures, coding methods, and analysis populations are not reported in the registry record.

The record lists a terminated status but does not report the reason for termination. It also does not report a sample-size justification, interim analyses, a statistical analysis plan, missing-data procedures, or multiplicity handling. The planning assumptions attached to sample-size illustrations should not be treated as a record of the study’s actual design.

Finally, the adverse-event entries show zero participants at risk in the recorded group. They therefore provide no basis for conclusions about adverse events among enrolled participants. Taken together, the registry information supports a description of the intended usability evaluation and its status, but not an assessment of the study’s findings, precision, or completeness.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Developing and Validating Fertilit-e — NCT03599661.
• Registry record last updated 2025-01-09; status last verified 2024-11.
• Results first posted 2025-01-09.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

17. Record Summary

NCT03599661, “Developing and Validating Fertilit-e,” is a Wake Forest University Health Sciences study focused on an eHealth fertility-preservation decision aid for young adults with cancer. The registry records enrollment of 21, a start date of 2018-08-15, a primary completion date of 2022-06-07, and terminated status.

The described Fertilit-e activity includes content review, interviews about content, functionality, and ease of use, and questionnaire completion over 45-60 minutes. The primary outcome is a participant count for alpha usability, assessed through think aloud interviews with planned qualitative analysis. Comprehensibility is listed as a secondary outcome.

The record lists three outcome measures and zero analyses. It does not report observed usability or comprehensibility results, an analysis population, or the reason for termination. Allocation is not stated, and the registry notes that the arms are not a like-for-like control comparison. The record documents an evaluation aim, but does not provide analyzed findings or a comparative estimate.