This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Edessy ICSI Outcome Embryo Score (EIOS) Efficacy (NCT02082288), a na phase 1, phase 2 study. The primary outcome is Clinical Pregnancy.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02082288 |
| Phase | Phase 1, Phase 2 |
| Condition | Infertility |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 243 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Al-Azhar University |
| Results posted | Yes |
2. Clinical Question
Population
The condition listed is infertility. Enrollment is 243, but the registry record does not report further participant characteristics or specify the primary-outcome analysis population. The description therefore does not establish which participant subgroups were represented or whether every enrolled participant contributed to the outcome assessment.
Intervention
The listed intervention is the Edessy ICSI Outcome Embryo Score, and the arm description is ICSI. The study summary describes its purpose as detecting ICSI outcome according to EIOS. The registry record does not explain how the score was calculated, how it was used, or what score categories were applied.
Comparator
No comparator group is listed. The study is recorded as single-group, with allocation marked NA. It is therefore not a randomized, like-for-like comparison of ICSI with a separate control treatment or score-guided strategy. A comparison group is not reported in the registry record.
Primary question
The primary endpoint is clinical pregnancy, defined by the presence of a gestational sac on transvaginal ultrasonography at six weeks gestation. The registry record gives the endpoint definition and timeframe, but not the number of participants who met it or an estimate of the association between EIOS and pregnancy.
In statistical terms, the stated question concerns whether an ICSI outcome, classified according to EIOS, is accompanied by clinical pregnancy. With no comparator and no posted outcome count or analysis, the registry record cannot establish a treatment contrast or quantify how strongly the score relates to the endpoint. The score's intended role and the way its relationship to pregnancy was to be evaluated are not reported in the registry record.
3. Trial Design
The registry record classifies this study as single-group, with allocation marked NA and masking listed as none. It lists the Edessy ICSI Outcome Embryo Score as an intervention and describes the arm as ICSI. These design details indicate that the record does not describe randomized assignment between comparison arms. The record also says the study's purpose was to detect ICSI outcome according to EIOS, but it does not give a fuller account of the study procedures.
The study is listed as phase 1 and phase 2, with enrollment of 243 and a completed status. The recorded start is 2010-12, and primary completion is 2012-09. Al-Azhar University is listed as sponsor. These registry fields describe the study's classification and status; they do not, by themselves, provide evidence about the primary outcome.
The primary endpoint is clinical pregnancy, assessed at six weeks gestation by identifying a gestational sac on transvaginal ultrasonography. The registry lists one outcome measure and no analyses. It does not report the number assessed for the endpoint, an outcome count, an effect estimate, or a statistical method used for the primary analysis. The protocol details, eligibility criteria, follow-up procedures, and sample-size justification are not reported in the registry record.
Because there is no listed comparator, the design cannot directly estimate a between-group treatment effect. A single-group result, if reported, would describe the endpoint frequency in the study group; it would not by itself distinguish the influence of EIOS from other explanations. The record's completion status should not be confused with a posted analysis: the primary outcome result is not reported in the registry record.
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
| Stage | Edessy ICSI Outcome Embryo Score |
|---|---|
| STARTED | 243 |
| COMPLETED | 243 |
| NOT COMPLETED | 0 |
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: 243 infertile couples, attending the ART unit, International Islamic Center for Population Studies and Research (IICPSR), -Al- Azhar University
| Characteristic | Unit | Edessy ICSI Outcome Embryo Score |
|---|---|---|
| Participants analysed | 243 | |
| Age, Continuous | years | 30.12 (SD 3.51) |
| Sex: Female, Male: Female | Participants | 243 |
| Sex: Female, Male: Male | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Clinical Pregnancy, measured over 6 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is clinical pregnancy, measured in participants. The registry definition is the presence of a gestational sac at six weeks gestation, identified using transvaginal ultrasonography. This makes the outcome binary for each participant: the defined finding is either recorded as present or not present. The timeframe and assessment method specify what counts as the endpoint.
Clinical pregnancy is used as an observable outcome of an ICSI cycle in the study's stated evaluation of outcomes according to EIOS. A defined endpoint helps ensure that outcome classification refers to a specified clinical finding, rather than to an unspecified notion of success. The registry record does not report additional criteria for determining the endpoint, how ambiguous assessments were handled, or how assessments were coordinated.
The definition alone does not show how often clinical pregnancy occurred. No event count, denominator for the endpoint, or estimate of its frequency is reported in the registry record. Without those values, the endpoint cannot be quantified or compared across score levels. The record also does not report an analysis of whether the score predicts, classifies, or otherwise relates to clinical pregnancy. Those distinctions matter: defining an outcome is not the same as demonstrating a statistical relationship with it.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clearly defined primary endpoint but does not post its result. It gives no clinical-pregnancy count, analysis denominator, estimated event frequency, confidence interval, or p-value. Consequently, the available registry information does not quantify the outcome or its statistical precision. It also does not establish whether the endpoint was observed in the study group at all.
The study is recorded as single-group, and no comparator is listed. Even if a group-level pregnancy frequency were available, it would describe that group rather than provide a randomized contrast. A comparison intended to assess whether an outcome differs by score category would require category-specific data and an analysis; neither is reported in the registry record. The score's categories and any prespecified relationship between score and outcome are also not reported.
The registry lists one outcome measure and no analyses. This does not identify a statistical test, model, adjustment strategy, or estimate of uncertainty. Those analysis details are not reported in the registry record. Without them, there is no basis for interpreting a statistical significance test, an adjusted association, or the robustness of an estimate. No inference about the score's predictive performance can be drawn from the endpoint definition alone.
Adverse-event fields list zero participants at risk and zero affected participants for both serious and other events; deaths are recorded as null. Since the at-risk counts are also zero, those fields do not establish that adverse events were absent among an assessed study population. The registry record does not provide interpretable safety denominators or further safety results.
The study is marked completed, but completion status is not a substitute for outcome reporting. Statistical interpretation depends on the observed data, the denominator, and the analysis approach. Those elements are not reported in the registry record, so the posted information supports a description of the study question and design, not a conclusion about the magnitude, direction, or precision of the primary outcome.
9. Statistical Methods Explained
The registry record identifies the endpoint and study structure, but it does not report an analysis method or numerical result. The explanations below describe general statistical concepts relevant to this kind of endpoint; they are not claims about analyses actually performed in the study.
What does a binary endpoint measure?
For a binary endpoint, each participant is classified according to whether the defined event occurred. A count of participants with the event, together with the number assessed, can be used to describe the observed event frequency. The count and denominator need to refer to a clearly defined population and follow-up period. Here, the registry definition supplies the event criterion and timeframe, but the event count and analysis denominator are not reported in the registry record.
An event frequency is descriptive. It does not, on its own, show why the event occurred or whether a score caused a change in its occurrence. That distinction is especially important in a single-group design without a listed comparator. A score-outcome association would require information about scores and outcomes, along with a defined analysis. Those details are not reported in the registry record.
What would a confidence interval add?
In general, a confidence interval expresses uncertainty around an estimated quantity. For a binary endpoint, an interval around an event frequency can show how compatible the data are with a range of underlying frequencies, given the method's assumptions. Its width depends in part on the amount and distribution of the data. An interval around a difference or association would address uncertainty in that comparison or relationship, rather than the event frequency alone.
No confidence interval or point estimate for clinical pregnancy is reported in the registry record. It is therefore not possible to assess precision, or to distinguish a tightly estimated result from one with substantial uncertainty. An endpoint definition and enrollment figure do not supply the missing event count or analysis denominator.
What can be inferred from a single-group design?
As a general matter, a single-group study can describe outcomes in the group that was observed. It does not provide a contemporaneous control group for estimating what would have happened under a different intervention or strategy. Other factors may contribute to the observed outcome, and a descriptive result cannot separate those influences without additional design features or assumptions.
The record lists no comparator and marks allocation NA. It does not state whether the analysis was intended to compare score levels, assess prediction, or address another statistical question. Without a specified comparison and posted results, no causal or comparative effect can be estimated from the registry information.
How should planning illustrations be understood?
In general, sample-size planning uses assumptions about the effect of interest, variability or event frequency, significance level, allocation, and analysis method. The record describes a planning illustration based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such an illustration is a planning exercise, not an observed result or evidence that a study had a particular probability of detecting an effect.
The described assumptions use two arms, whereas this study is recorded as single-group. They therefore should not be read as a description of the study's actual allocation. The sample-size justification for the trial itself is not reported in the registry record. The observed effect underlying any such illustration is not accompanied by a posted outcome count or analysis in the registry information, so the illustration cannot replace a reported trial result.
What analysis choices remain unknown?
The registry record does not report a statistical test, a model, covariates, score thresholds, subgroup analyses, handling of repeated or incomplete observations, or a method for estimating uncertainty. It also does not report an analysis population. These choices can affect the question answered and the interpretation of a result. For example, an unadjusted description and an adjusted association answer different questions, while a predictive analysis would require defined performance measures and validation procedures.
These are general methodological considerations, not evidence that any particular method was used. Since no analyses are listed and no result is reported, there is no sponsor analysis to interpret or recalculated estimate to compare with it. The appropriate statistical reading is limited to the design classification, endpoint definition, and absence of a posted analysis.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Edessy ICSI Outcome Embryo Score | 243 | 71 | 29.2% | 23.6% to 35.4% | 23.9% to 35.2% | 23.9% to 35.2% |
R code and output
arm <- c("Edessy ICSI Outcome Embryo Score")
n <- c(243)
events <- c(71)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Edessy ICSI Outcome Embryo Score 243 71 29.2 23.6 35.4 23.9 35.2 23.9 35.211. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure, designated as clinical pregnancy, and no analyses. It does not report whether additional outcomes or hypotheses were examined outside the listed record, or whether any multiplicity procedure was planned or used. A single listed endpoint does not establish that no other analyses were conducted. Any multiplicity strategy is not reported in the registry record.
Missing-data handling is also not described. The record does not report the number of participants with an endpoint assessment, the number with missing assessments, reasons for missingness, or any imputation or sensitivity analysis. The endpoint definition gives the assessment time and method, but not how participants without an interpretable assessment were classified or handled.
The primary-outcome population field is blank, and an analysis population is not reported in the registry record. It is therefore unclear which participants would be included in an endpoint estimate or how the enrollment figure relates to the outcome denominator. The registry record does not describe an intention-to-treat population, a per-protocol population, or another defined analysis set.
These omissions limit interpretation even before considering the absence of an outcome result. Without a denominator and missing-data account, an event frequency could be difficult to interpret; without an analysis population and multiplicity information, the scope of any statistical claim would also remain uncertain. No assumptions about these matters can be made from the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was intended to examine ICSI outcome according to EIOS and that clinical pregnancy was its primary endpoint. It specifies the endpoint as a gestational sac identified by transvaginal ultrasonography at six weeks gestation. It also records a single-group design, enrollment of 243, and completed status. These registry entries describe the study question and its registry classification.
The record does not report the number of clinical pregnancies, the number assessed, or an analysis of the relationship between EIOS and pregnancy. It therefore does not show the observed endpoint frequency, the size or direction of any association, or how precisely such an association could be estimated. The definition of an outcome is not itself evidence that the outcome occurred at a particular frequency.
Because no comparator is listed, the study record does not provide a randomized contrast between alternative treatments or strategies. A result from one group, even if available, would not by itself demonstrate that the score caused a difference in outcomes. The registry also does not report score categories, a predictive model, or validation of the score. Claims about discrimination, calibration, or clinical utility cannot be made from the listed information.
Finally, the adverse-event fields do not establish safety: they show zero at-risk counts as well as zero affected counts, and deaths are null. The registry information supports a description of the intended endpoint and design, but not a conclusion about efficacy, predictive performance, or safety.
13. Why This Trial Matters Statistically
This record illustrates why a registered endpoint and a posted result are different kinds of information. The endpoint definition states what the study intended to count, including the assessment method and timeframe. An outcome count, denominator, and analysis would be needed to estimate how often the endpoint occurred and how uncertain that estimate is. Those results are not reported in the registry record.
The single-group classification also matters for interpretation. A statistical description within one group cannot substitute for a comparison against an appropriate control. Even a precise estimate of one group's event frequency would not isolate the effect of EIOS or distinguish its role from other influences. The registry does not report a comparator or a score-outcome analysis.
For clinical researchers, the record highlights the value of reporting analysis populations, missing-data handling, statistical methods, and estimates with measures of uncertainty. These details allow readers to understand which participants contributed to a result, what question the analysis addressed, and how much precision the evidence supports. Here, those elements are not reported in the registry record.
The completed status and enrollment figure provide context, but neither can stand in for an analyzed endpoint. The statistical importance of this study record is therefore chiefly about interpretability: it states a clinical question and endpoint, while leaving the result and its evidential strength unquantified.
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 trial-specific limitation for interpreting the registry information is the absence of a reported primary-outcome result. Although clinical pregnancy is defined, the registry record does not report an event count, endpoint denominator, estimate, confidence interval, or p-value. The outcome therefore cannot be quantified from the posted information.
The single-group design and lack of a listed comparator limit what a result could establish about differences between strategies. The record also does not explain how EIOS was calculated, how score levels were defined, or how the score was related to the endpoint. Without those details, the intended statistical relationship is not clear.
The primary-outcome population is not specified, and missing-data procedures and analysis populations are not reported in the registry record. The protocol, eligibility criteria, sample-size justification, and statistical analysis plan are also not reported. These gaps leave uncertainty about how participants and observations would be selected for analysis and how the primary question was intended to be tested.
Safety fields list zero participants at risk and zero affected participants for serious and other adverse events, with deaths recorded as null. Those fields do not provide usable safety denominators. Together, these limitations mean the registry record is insufficient for estimating clinical-pregnancy frequency, assessing score performance, or evaluating comparative effects.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Edessy ICSI Outcome Embryo Score (EIOS) Efficacy — NCT02082288.
- Registry record last updated 2015-01-26; status last verified 2015-01.
- Results first posted 2014-10-16.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT02082288 is titled Edessy ICSI Outcome Embryo Score (EIOS) Efficacy. The registry lists infertility as the condition, Al-Azhar University as sponsor, phase 1 and phase 2, single-group design, no masking, and enrollment of 243. Status is completed; the recorded start is 2010-12 and primary completion is 2012-09.
The stated purpose is to detect ICSI outcome according to EIOS. The primary endpoint is clinical pregnancy, defined as a gestational sac identified by transvaginal ultrasonography at six weeks gestation. No comparator is listed. The registry lists one outcome measure and no analyses, and does not report a primary-outcome count or estimate.
The adverse-event fields list zero at-risk and affected participants for serious and other events; deaths are null. These fields do not establish absence of adverse events in an assessed population. Overall, the record describes the study design and endpoint but does not report results needed for statistical interpretation.