Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle (NCT03387059), a randomized phase 4 study. The primary outcome is Implantation Rate.

2. Clinical Question

3. Trial Design

ENDOMEDE, registered as NCT03387059, was described as a multicentre, prospective, randomized controlled interventional clinical investigation of Forielle, a medical device for endometrial washing. The registry lists the study as Phase 4, with randomized allocation, no masking, and a parallel-group model. The named groups were Forielle Endometrial Washing and No Endometrial Washing. Detailed descriptions of the care received by participants in each group are not reported in the registry record.

The study addressed infertility in the context of assisted reproductive practice after controlled ovarian stimulation. The registry lists a start date of 2018-01-12 and a primary completion date of 2018-06-12. Its status is terminated. Enrollment was 9. The registry attributes early termination to poor feasibility and sustainability, which led to a slow recruitment rate. It does not report a planned enrollment target, recruitment projections, or a detailed account of how termination was decided.

The stated primary outcome was implantation rate, measured after embryo transfer during post-embryo-transfer days 21 to 28. The listed secondary outcomes were the number of participants with positive and negative pregnancy, the number of participants with confirmed ongoing pregnancy, and the number of participants with device incidents. The registry reports 4 outcome measures, but a complete account of their specifications is not reported in the registry record.

Although the design was randomized, the registry reports no outcome analyses. It does not report the randomization sequence method, allocation concealment, masking beyond stating none, or any analysis plan. The actual rationale for the planned sample size is not reported in the registry record. With no primary endpoint data collected, the intended randomized comparison cannot be evaluated from the posted results.

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.

Before assignment: Nine participants were enrolled and the study was prematurely terminated due to the poor feasibility and sustainability, leading to slow recruitment rate.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.

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: The Intent-to-Treat (ITT) population included all randomized participants into the trial.

6. Primary Endpoint

The registry lists the primary outcome as Implantation Rate, measured over Post Embryo Transfer (PET) Days 21 to 28.

The primary endpoint was implantation rate, defined in the registry as the number of intrauterine gestational sacs divided by the number of embryos transferred. The assessment timeframe was post-embryo-transfer days 21 to 28. This measure expresses the observed gestational sacs relative to embryos transferred, placing the result in the context of the number of embryos available to implant rather than treating a sac count alone as the outcome.

In general, an endpoint should correspond to the clinical question and be defined consistently so that the comparison between randomized groups has a clear interpretation. Implantation rate was selected to assess an early outcome following embryo transfer and to address the study’s stated aim concerning endometrial condition and implantation. The registry gives the operational definition, but additional endpoint rules are not reported in the registry record. For example, rules for handling multiple sacs, unavailable assessments, or participants with no embryo transfer are not described.

The registry explicitly states that primary data were not collected because the study was terminated early due to poor feasibility and sustainability, leading to slow recruitment. Accordingly, no implantation-rate estimate, group comparison, or measure of uncertainty is reported. The endpoint definition clarifies what the study intended to measure; it does not establish what the observed outcome would have been.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes random allocation to a Forielle endometrial-washing group or a no-endometrial-washing group. Randomization is generally used to make the groups comparable, on average, with respect to measured and unmeasured characteristics at the point of allocation. It does not guarantee that groups will be balanced in a particular small trial. The method used to generate the allocation sequence and the method used to conceal it before assignment are not reported in the registry record.

The listed design is parallel-group and unmasked. In a parallel-group study, participants are assigned to a group and the outcomes are compared between groups. No masking means the registry does not identify blinding; the specific roles of participants, clinicians, and outcome assessors are not described. Whether lack of masking could affect outcome assessment depends on how the outcome is measured and how assessment is conducted. Further details are not reported in the registry record.

What does the implantation-rate definition imply?

The primary outcome is a ratio: the number of intrauterine gestational sacs divided by the number of embryos transferred. In general, analysis of ratio-based outcomes requires clear rules for defining the numerator and denominator for each participant and for combining observations across participants. The registry supplies the endpoint definition but does not report the planned statistical method, whether the ratio was analyzed at participant or embryo level, or how clustering of multiple embryos within a participant would be handled. These choices can affect both the estimate and its uncertainty.

The timeframe was post-embryo-transfer days 21 to 28. In general, a stated assessment window helps establish when an outcome is counted, while the protocol should also specify how assessments outside the window are handled. Such rules are not reported in the registry record. The registry says that primary data were not collected, so there are no posted observations to which an analysis method could be applied.

How should uncertainty be considered?

In general, an estimate is a summary of the observed data, and a confidence interval expresses the uncertainty around that estimate under specified assumptions. A p value addresses compatibility of the data with a statistical null model; it is not a measure of clinical importance or the probability that a treatment works. These concepts require observed outcome data and an analysis plan. The registry lists 0 analyses and reports no primary estimate, confidence interval, or p value, so none of these inferential quantities is available for the implantation comparison.

Small samples usually yield limited information and can produce imprecise estimates. Here, enrollment was 9, and the study ended before the primary endpoint was collected. Thus, the absence of an estimate is not simply a case of a wide confidence interval: there is no posted primary estimate or interval to interpret. A statement about statistical power based on observed primary results would not be appropriate.

What is the role of the planning illustration?

The registry describes a planning illustration based on an observed effect, with two-sided significance level 0.05, equal allocation, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. For time-to-event calculations, the stated output is the total number of events using the Schoenfeld approach; for other calculations, it is participants per arm. These are general planning assumptions and do not establish the design rationale used for ENDOMEDE. The protocol-specific sample-size justification is not reported in the registry record.

Planning illustrations are not observed power. They describe sample-size requirements under assumptions rather than the probability that a completed trial has demonstrated an effect. Because the primary endpoint data were not collected, an observed primary effect is not reported in the registry record. Any sample-size illustration should therefore be understood only in the context of its stated assumptions, not as evidence about the trial’s actual clinical result or as proof that the study was adequately sized.

The registry does not report the intended model, covariate adjustment, analysis population, missing-data procedure, or sensitivity analyses. Those decisions are important for interpreting a randomized comparison, especially when outcomes are unavailable or follow-up is incomplete. Without the protocol-level statistical details and primary observations, a reconstruction of the planned analysis is not possible from the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists implantation rate as the primary outcome and names secondary outcomes concerning positive and negative pregnancy, confirmed ongoing pregnancy, and device incidents. It also reports 4 outcome measures. The complete outcome specifications, including the measure not evident from the listed secondary outcome names, are not reported in the registry record. No result values or statistical analyses are reported for these outcomes.

In general, testing several outcomes can increase the chance of finding at least one apparently notable result when each is assessed separately. A prespecified hierarchy, adjustment procedure, or clear distinction between primary and exploratory outcomes can help readers understand how multiple comparisons were handled. The registry does not report a multiplicity strategy, testing hierarchy, or analysis plan. Since no analyses are listed, there are no posted inferential results whose multiplicity adjustment can be evaluated.

The primary endpoint was not collected following early termination. The record does not describe whether secondary outcomes were collected, whether the listed outcomes were unavailable, or how missing outcome data would have been handled. These details are not reported in the registry record. The cause of termination is stated as poor feasibility and sustainability leading to slow recruitment; the record does not give participant-level reasons for missing observations or a detailed account of follow-up.

The analysis population is also not described. The registry does not state whether the planned analysis would have followed randomized assignment, included only participants who received the intervention, or used another population definition. These details are not reported in the registry record. With no primary outcome data and no analysis results, neither the handling of missingness nor the effects of alternative analysis populations can be assessed.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The posted safety counts list 5 participants at risk in the Forielle Endometrial Washing group and 4 in the No Endometrial Washing group. In the serious adverse-event category, 0 participants were affected in each group. In the other adverse-event category, 0 participants were affected in each group. Deaths are reported as 0 in both groups. These are counts, not comparative estimates adjusted for follow-up or other factors.

In general, an “at risk” count indicates the number of participants represented as having been considered for the event summary. The registry does not provide detailed event definitions, observation time, ascertainment methods, or participant-level event narratives. These details are not reported in the registry record. Thus, the counts should be read as the posted safety summary, not as a complete account of all possible harms or as proof that an event cannot occur.

With only the reported enrollment and no events recorded in these categories, the data provide limited information about the frequency of uncommon events. The registry does not report a formal comparison of adverse-event rates. The zero counts do not establish equivalent safety between groups, and they do not support a precise estimate of risk. They describe what was recorded among the participants listed in the safety summary.

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

The registry establishes that ENDOMEDE was designed as a randomized comparison of Forielle endometrial washing with no endometrial washing in assisted reproductive practice after controlled ovarian stimulation. It also records early termination, enrollment of 9, and the stated reason of poor feasibility and sustainability leading to slow recruitment. Those details characterize the study’s conduct, but they do not answer its primary clinical question.

The primary outcome definition is clear at a basic level: intrauterine gestational sacs divided by embryos transferred, assessed during post-embryo-transfer days 21 to 28. However, primary outcome data were not collected. No implantation rate or between-group estimate is reported. The registry therefore does not show whether the groups differed on the primary endpoint, how large any difference might have been, or how precisely such a difference could be estimated.

The registry also lists pregnancy-related secondary outcomes and device incidents, but does not report their results or analyses. The safety summary records 0 serious adverse events, 0 other adverse events, and 0 deaths in each group. Those counts are descriptive and based on the participants listed as at risk. They do not establish the absence of risk or a safety equivalence between the groups.

In general, a trial result should be interpreted by considering the estimated effect, its uncertainty, the design, and the completeness of outcome reporting. In this record, the main endpoint estimate and its uncertainty are unavailable. The termination and lack of endpoint collection mean that the randomized comparison remains unresolved in the posted results. This is not evidence of benefit, lack of benefit, or equivalence; it is an absence of reported primary outcome data.

The distinction matters: a trial can have a defined question and a randomized design without generating evidence that answers that question. The registry record supports conclusions about the intended endpoint, study design, recruitment difficulty, and posted safety counts. Conclusions about implantation outcomes cannot be drawn from these data.

13. Why This Trial Matters Statistically

This trial is statistically informative because it illustrates the difference between a planned comparison and an estimable result. ENDOMEDE had a stated primary endpoint and randomized groups, but the registry reports that primary data were not collected after early termination. Randomization alone cannot provide an estimate when the outcome observations needed for comparison are absent.

The small enrollment of 9 is part of the record, but the decisive constraint is not merely that the sample may yield imprecise estimates. There is no posted primary endpoint estimate at all. This distinction helps readers avoid treating an unavailable result as a null finding, or treating termination as evidence that the intervention did or did not affect implantation.

The record also shows why outcome definitions and analysis details matter. The implantation rate has a numerator and denominator, yet the planned method for analyzing that ratio and the rules for participant-level outcomes are not reported. A clear outcome definition is necessary, but it is not enough to assess the validity, precision, or robustness of a result without observations and a stated analytical approach.

Finally, the safety counts require restraint. Zero recorded events in both groups are useful descriptive information, but small numbers and unreported follow-up details limit what can be inferred. The statistical contribution of this record is therefore chiefly about the limits of interpretation: it documents a randomized investigation and its early termination, while leaving the main efficacy comparison unanswered.

14. 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 is that the registry states that primary data were not collected. There is consequently no implantation-rate estimate, group contrast, or uncertainty measure. This prevents assessment of the primary endpoint, regardless of the randomized design. The registry also reports no outcome analyses.

Enrollment was 9, and the study was terminated early because of poor feasibility and sustainability leading to slow recruitment. The record does not report the planned enrollment, recruitment targets, participant flow, or the number of participants who completed follow-up. These details are not reported in the registry record. The actual reasons for termination beyond the stated feasibility and recruitment explanation are not described.

The registry names the primary endpoint and its timeframe but does not report operational details beyond the definition of sacs divided by embryos transferred. The planned statistical model, analysis population, handling of multiple embryos per participant, missing-data procedures, and sensitivity analyses are not reported in the registry record. The protocol-specific sample-size justification is also not reported.

Secondary outcomes are named, but their result values and analyses are absent. The full specifications for the 4 outcome measures, and any multiplicity plan, are not reported in the registry record. Safety reporting gives group counts and event counts but not detailed event descriptions, follow-up duration, or ascertainment methods. These limitations restrict interpretation of both the unreported efficacy outcomes and the descriptive safety summary.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle — NCT03387059.
• Registry record last updated 2019-09-24; status last verified 2019-08.
• Results first posted 2019-09-24.
• 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.

18. Record Summary

NCT03387059 is the registry record for ENDOMEDE, a multicentre, prospective, randomized, open-label, parallel-group investigation of Forielle endometrial washing compared with no endometrial washing. It concerned assisted reproductive practice after controlled ovarian stimulation and lists infertility as the condition. The registry identifies the study as Phase 4.

Enrollment was 9. The listed start date is 2018-01-12, and the primary completion date is 2018-06-12. The study status is terminated; the registry attributes this to poor feasibility and sustainability leading to slow recruitment. Implantation rate was the primary outcome, defined by intrauterine gestational sacs divided by embryos transferred, but the record says primary data were not collected. No analyses are listed. The safety summary records 0 serious adverse events, 0 other adverse events, and 0 deaths in each group.