Endometrial Injury for Unexplained Infertility: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Endometrial Injury for Unexplained Infertility (NCT02863198), a randomized na study. The primary outcome is Measurement of Uterine Artery Pulsatility Index.

2. Clinical Question

The clinical question concerns a physiologic measurement rather than a direct measure of pregnancy. Pulsatility index reflects variation in blood velocity within the uterine artery; the registry description says that higher values indicate increased vascular resistance. The comparison therefore asks whether the groups differed on this vascular measure at the specified treatment-cycle time point. It does not, by itself, establish whether any difference in the measure corresponds to a difference in pregnancy outcomes.

The registry reports random allocation and a parallel-group design. It describes Doppler examination for all participants on day 5, followed by repeat Doppler examination on the day human chorionic gonadotropin was prescribed. The primary outcome is defined as the measurement at that latter time point, with a timeframe of one week. The record does not explain the basis for selecting the endpoint or how the timing of the measurement was set.

3. Trial Design

The registry identifies this as a randomized, single-masked, parallel-group study, with enrollment of 120 and status recorded as completed. The recorded study dates are 2013-10 for study start and 2016-02 for primary completion. The phase is listed as NA. The sponsor is Benha University. Further details about the setting, recruitment process, or the person or people masked are not reported in the registry record.

The summary describes 120 women with unexplained infertility divided randomly into two groups of 60. All participants received clomiphene citrate and human menopausal gonadotropin. On day 5, Doppler examination was performed for all participants. Local endometrial injury was performed on that day only in the study group. Doppler studies were repeated for all participants on the day human chorionic gonadotropin was prescribed.

The intervention description says the injury was performed under aseptic conditions, usually without anesthesia, using pipelle endometrial sampling. It specifies the posterior wall, midline, and 10-15 mm from the fundus. The no-injury arm is described as receiving no endometrial injury. The registry does not report additional procedural details, adherence, crossover, or co-interventions beyond the medications in the summary.

There is an arm-labeling ambiguity in the record. The brief summary identifies the no-injury group as the control group, while the arm and control fields associate the control designation with the endometrial-injury arm. This makes the mapping of the registry's control label to the named groups unclear. The numerical comparisons are described by their arm names rather than relying on that label.

Randomization is reported, but the sequence-generation method, allocation concealment, and any stratification are not reported in the registry record. The record also does not give a participant flow account, the number analyzed for each outcome, or whether all randomized participants were included in the analyses. Single masking is stated, but the masked parties and the success of masking are not reported.

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

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.

6. Primary Endpoint

The registry lists the primary outcome as Measurement of Uterine Artery Pulsatility Index, measured over one week.

The primary endpoint is measurement of uterine artery pulsatility index at the day of human chorionic gonadotropin administration. Its timeframe is listed as one week. The index is described as the difference between peak systolic and end-diastolic blood velocities divided by mean velocity during the cardiac cycle. It is a continuous measure, reported as a mean and standard deviation for each group.

In general, a continuous endpoint preserves information about the observed values across participants, rather than reducing the outcome to categories such as high or low. Comparing group means can assess whether the average measured index differs between the randomized groups. The standard deviation describes variation among individual measurements within a group; it is not the uncertainty around the group mean.

The registry description states that higher pulsatility-index values indicate increased vascular resistance. That helps explain the physiologic interpretation of the measure, but does not establish what magnitude of difference would be clinically important. A threshold for meaningful change, the rationale for choosing this endpoint, and evidence connecting a change in this measure to pregnancy outcomes are not reported in the registry record.

The timing matters to interpretation: the reported primary measurement is at human chorionic gonadotropin administration, following the day-5 assessment described in the study summary. The posted comparison concerns group means at that specified measurement, not a reported change-from-baseline analysis. Whether the analysis used repeated measurements or adjusted for the earlier Doppler measurement is not reported in the registry record.

7. Results Posted in the Registry

• Non Endometrial Injury: mean 2.35 versus 2.40 on control; difference -0.05 (95% CI -0.14 to 0.04), standardized effect d = -0.20; z-test p = 0.285.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Pregnancy Rate Between the Study and the Control Group

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Non Endometrial Injury: 6.7% (4/60) versus 18.3% (11/60) on control; risk difference -11.7 percentage points (95% CI -23.3 to -0.0), risk ratio 0.36 (0.12–1.08); unadjusted two-proportion z-test p = 0.053.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Non Endometrial Injury and the control. The interval gives the range of effects that remain compatible with the data.

The registry posts pregnancy rate as the secondary outcome. It describes six outcome measures and six analyses overall, but only one secondary outcome is posted. The posted secondary result points toward a higher observed pregnancy count in the endometrial-injury group, while the recalculated comparison is close to the conventional significance boundary and the sponsor's reported threshold-form p-value falls on the other side of that boundary. The detailed counts and estimates are stated with the outcome results; the overall interpretation is that the registry and recalculation do not give a consistent significance summary.

This secondary endpoint is clinically distinct from the primary physiologic measurement. The primary comparison concerns uterine artery pulsatility index, while pregnancy rate concerns a participant outcome at the stated follow-up. The primary mean comparison does not demonstrate a pregnancy effect, and a secondary pregnancy finding does not establish a change in the primary measure. The record does not report a participant-level analysis connecting the two outcomes or a mediation analysis.

In general, secondary outcomes can be useful for describing other potential effects, but they carry more uncertainty when many outcomes or analyses are considered. If multiple statistical tests are conducted, the chance of at least one apparently notable result can increase unless the analysis plan accounts for multiplicity. Whether and how multiplicity was handled is not reported in the registry record. The registry does not identify a hierarchy of outcomes or indicate that the secondary result was adjusted for multiple testing.

The pregnancy result should therefore be read as a secondary, unadjusted comparison whose reported and recalculated significance summaries differ. It does not settle the primary endpoint question, and it should not be treated as a definitive stand-alone conclusion about the intervention. Other outcome measures and their results are not reported in the registry record, so the full pattern across all listed measures cannot be assessed.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Pregnancy Rate Between the Study and the Control Group

9. Statistical Interpretation

10. Statistical Methods Explained

The registry identifies the primary reported analysis as a two-sided t-test comparing the two groups. A t-test evaluates whether the data are compatible with a difference between group means, while a two-sided test allows for differences in either direction. The registry gives the analysis method and a threshold-form p-value, but does not report the test statistic, exact p-value, degrees of freedom, or analysis population.

What does a mean difference represent?

The comparison is expressed as no-injury group minus endometrial-injury group. For the primary endpoint, the recalculated mean difference is -0.05. A negative value means the no-injury group mean is lower in this subtraction order; it is not a statement about the size or clinical importance of the difference by itself. The confidence interval gives a range of values compatible with the posted summary data under the calculation's assumptions. Because this interval includes zero, the recalculation does not give clear evidence of a nonzero mean difference.

The recalculation is unadjusted and based on the posted group means, standard deviations, and sample sizes. In general, an unadjusted comparison does not account for other participant characteristics or earlier measurements. Whether the sponsor used an adjusted model, a different analysis population, or another handling of the data is not reported in the registry record, so the reason for the different p-values cannot be determined from the record.

How should the p-value be understood?

In general, a p-value describes how incompatible the observed data are with a specified null model, conditional on the assumptions of the test. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. The primary recalculated p-value is 0.285, while the registry reports p <0.05 for the sponsor's two-sided t-test. Those are different reported results; the record does not give enough detail to reconcile them.

For the secondary pregnancy outcome, the registry names a chi-squared analysis. This type of test compares categorical outcome counts between groups. The recalculation instead reports a risk difference and its confidence interval using the posted counts. In general, different methods, assumptions, or analysis choices can produce different estimates of uncertainty and p-values, especially when event counts are limited. The exact sponsor calculation is not reported, so no specific explanation can be assigned to the difference between the registry's threshold-form p-value and the recalculated result.

Why can variability matter?

The primary outcome is continuous, and its group standard deviations describe variation in measured index values among participants. In general, greater within-group variation makes it harder to distinguish a group difference of a given size from random variation. The recalculation uses the posted standard deviations and equal group sizes. The record does not report diagnostics for the distribution of the measurements, departures from test assumptions, or any alternative method used to address them.

For binary outcomes, event counts and the proportion of participants with the outcome are central. In general, when counts are limited, confidence intervals can be wide and estimates may be sensitive to a small number of outcome observations. The pregnancy comparison is presented as a difference in proportions, with risk-ratio and odds-ratio estimates also available in the statistical output. These measures describe relative and absolute contrasts differently; they should not be treated as interchangeable quantities.

What is not described?

The registry record does not report a detailed statistical analysis plan, justification for sample size, handling of missing outcome data, intention-to-treat or per-protocol population, covariate adjustment, or planned subgroup analyses. It does not report whether an interim analysis occurred or whether any stopping rule was used. The record lists six outcome measures and six analyses, but only one secondary outcome is posted. These omissions limit the ability to assess whether the posted comparisons match the original analysis plan.

All inferential statements above about recalculated comparisons refer to simple unadjusted calculations from the posted summaries. They do not replace the sponsor's own analysis or recover unreported participant-level data. General statistical explanations describe how these methods work; they are not additional findings from the trial.

11. Confidence Intervals and Precision

The primary recalculated mean difference is -0.05, with a 95% confidence interval from -0.142 to 0.042. In general, a confidence interval describes the range of effect values that are compatible with the observed data under the method's assumptions. It is not a guarantee that the true effect lies within those endpoints, and it does not assign a probability to any particular value after the data have been observed.

For the primary comparison, the interval includes zero and spans values on either side. This indicates that the posted summaries do not pin down the direction of the mean difference with precision. The point estimate is close to zero, but the interval also allows for differences larger in magnitude than that point estimate. The registry does not state what difference in pulsatility index would be clinically important, so the interval cannot be judged against a reported clinical threshold.

For pregnancy rate, the recalculated risk difference is -0.117, with a 95% confidence interval from -0.233 to -< 0.001. That interval lies near zero at its upper limit. The corresponding unadjusted p-value is 0.053. A confidence interval and p-value are related summaries of uncertainty, but the p-value is not a measure of effect size and a threshold distinction should not obscure how close the interval comes to zero.

In general, precision depends on the amount of information in the data and on variation or event frequency. Each group contains 60 participants in the posted comparisons. The registry does not report a prespecified precision target or a clinically meaningful difference. These intervals summarize uncertainty for the recalculated unadjusted comparisons; the sponsor's analysis details and confidence intervals are not reported in the registry record.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total participants and not total events. Each row considers a target effect set at a stated fraction of the observed effect. For the primary continuous outcome, the listed per-arm figures are 413 and 552 for 100% of the observed effect, 733 and 982 for 75%, and 1,649 and 2,208 for 50%, for the 80% and 90% power targets respectively. For pregnancy rate, the corresponding figures are 125 and 167, 246 and 328, and 601 and 804.

In general, power is the chance that a specified analysis will detect an effect of a specified size if that effect is present and the planning assumptions hold. The 80% column gives the planned participants per arm for an 80% power target; the 90% column does the same for a 90% target. A higher target power requires more participants under otherwise unchanged assumptions. The curve expresses the same relationship visually: planning for a smaller effect requires more participants. Read the figures as illustrations tied to the observed effect and the stated statistical assumptions, not as a forecast of what happened in the completed trial.

The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is the stated fraction of the observed effect. These calculations are not the trial's original design justification. The original sample-size assumptions are not reported in the registry record. The planning figures are not observed power; they are hypothetical sample-size illustrations, and should not be used to infer that the completed study had a particular chance of detecting an effect.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.050; pooled standard deviation σ = 0.256.
2. n = 2 × (1.96 + 0.842)² × 0.256² / -0.050² = 412.2, rounded up to 413 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.0499999999999998                      # observed difference in means
sigma <- 0.256222559506379                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2863198)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 413 (80% power), 552 (90% power)
 75% of observed effect: n per arm = 733 (80% power), 982 (90% power)
 50% of observed effect: n per arm = 1,649 (80% power), 2,208 (90% power)
power.t.test: 413.2 
Simulated power at n = 413 per arm: 0.792 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry reports a two-sided t-test for the primary comparison with p <0.05. The unadjusted recalculation from the posted means, standard deviations, and group sizes gives a mean difference of -0.05, a 95% confidence interval from -0.142 to 0.042, and p = 0.285. The registry also reports a chi-squared analysis for pregnancy rate with p <0.05, while the recalculated unadjusted risk difference has p = 0.053.

These are not matching significance summaries. The registry does not report the sponsor's exact test statistics, exact p-values, confidence intervals, participant-level data, or additional analytical details needed to explain the differences. The available record therefore supports reporting the sponsor's stated analyses as the registry's reported results, while keeping the recalculations clearly identified as unadjusted results derived from the posted summaries. The record does not establish whether differing analysis populations, adjustments, or other choices account for the discrepancy.

The arm-label ambiguity adds a further interpretive caution: the registry's control designation does not align clearly with the group labels in the study summary. The comparisons described by named arms avoid assigning more meaning to that designation than the record permits. No explanation resolving either the label ambiguity or the differences in p-values is reported in the registry record.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures and six analyses, while only one secondary outcome is posted. The other outcome measures and their results are not reported in the registry record. Without the complete set of planned and analyzed outcomes, it is not possible to determine how many comparisons were considered or whether selective outcome reporting may have affected the visible results.

Multiplicity refers, in general, to the increased chance of observing at least one apparently unusual result when several statistical tests are performed. Common approaches include prespecifying a primary endpoint, adjusting significance thresholds, or interpreting secondary outcomes as exploratory. The registry identifies a primary endpoint and a secondary pregnancy outcome, but does not report a multiplicity adjustment, testing hierarchy, or detailed plan for interpreting multiple analyses. It is therefore not possible to know whether the reported threshold-form p-values account for the number of comparisons.

Missing-data handling is also not described. The group summaries list 60 participants per arm, but the record does not clarify whether all randomized participants contributed data to each outcome, whether any measurements were missing, or how missingness was handled. It does not report imputation, complete-case analysis, or sensitivity analyses. The number enrolled should not automatically be treated as the analysis denominator for every outcome without that information.

The analysis population is not specified. The registry does not state whether the reported analyses followed intention-to-treat, per-protocol, or another rule, nor how participants who deviated from assigned treatment would have been handled. Randomization helps balance groups at assignment, but interpretation of a randomized comparison also depends on how participants are retained and analyzed. These omissions constrain assessment of bias and reproducibility. A detailed protocol and statistical analysis plan are not reported in the registry record.

16. Safety Results

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

Other (non-serious) adverse events

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

The adverse-event record lists 0 serious adverse events among 60 participants at risk in the endometrial-injury group and 0 among 60 in the no-injury group. It also lists 0 other adverse events among 60 participants at risk in each group. These figures describe what is recorded for the stated groups and categories; they do not establish that no adverse events of any kind occurred beyond the registry entries.

In general, an observed count of zero does not prove that an event is impossible or that a treatment has no safety risks. The ability to detect uncommon events depends on the amount and duration of observation, as well as on how events are defined and collected. The registry's adverse-event section does not provide detailed event definitions, monitoring procedures, or a narrative account of how events were solicited and assessed.

Deaths are not reported in the registry record. The study summary describes a procedure, but the adverse-event figures alone do not provide a full assessment of procedural safety. They should be read as the posted serious and other adverse-event counts, not as a comprehensive safety conclusion.

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

The posted primary summaries show similar group means for uterine artery pulsatility index, and the unadjusted recalculated comparison has a confidence interval that includes zero. This means the posted summary statistics do not establish a clear difference in the mean index. It does not prove the groups were identical, nor does it rule out differences that the available sample and uncertainty could not distinguish clearly.

The pregnancy outcome has a different pattern in the observed counts, but its recalculated p-value is 0.053 and the registry's reported chi-squared result is p <0.05. That difference in statistical summaries, together with the secondary status of the outcome and the absence of a reported multiplicity plan, calls for caution. The result does not by itself establish a reliable treatment effect.

Statistical evidence and clinical importance are not the same. A p-value does not quantify the magnitude of an effect, and a confidence interval does not indicate whether the possible values are clinically meaningful unless an appropriate clinical threshold is known. Such a threshold is not reported for the pulsatility index or pregnancy comparison in the registry record.

The study concerns women with unexplained infertility receiving the described stimulation medications, and the primary measurement is taken at a particular point in the cycle. The record does not provide enough information about eligibility criteria, participant characteristics, setting, or follow-up to judge how readily these findings apply to other populations or care settings. The results should not be generalized beyond the studied groups and recorded outcomes without additional evidence.

Overall, the record supports a cautious description of the posted comparisons, not a claim that endometrial injury does or does not work. The primary recalculation does not show a clear mean difference, while the secondary outcome's sponsor-reported and recalculated significance summaries differ. The missing analytical details, arm-label ambiguity, and unreported outcomes limit stronger conclusions.

18. Why This Trial Matters Statistically

This trial is statistically instructive because it reports both a continuous physiologic endpoint and a binary pregnancy outcome. These outcomes answer different questions and use different measures of effect. The mean difference describes an average separation in a continuous index, while a risk difference describes an absolute separation in outcome proportions. Keeping those interpretations distinct is essential when a study includes multiple types of endpoints.

The record also makes visible the difference between a sponsor-reported test and a simple unadjusted recalculation from group summaries. For the primary endpoint, the sponsor's threshold-form p-value and the recalculated p-value are not concordant; the same is true for the secondary outcome. The registry does not give enough analytical detail to resolve why. This illustrates why complete reporting of analysis methods, exact estimates, uncertainty intervals, and analysis populations is important for independent interpretation.

Confidence intervals contribute information beyond a binary significance label. The primary interval spans zero, while the secondary interval approaches zero at one boundary. These estimates communicate uncertainty and possible effect directions more directly than a p-value threshold alone. However, without a prespecified clinically important difference, their practical significance cannot be established from the registry record.

The planning illustrations also show how sample-size requirements depend on the effect a study is intended to detect. Smaller target effects require larger planned groups under the stated assumptions. These illustrations are not evidence about the original design or a measure of the completed trial's observed power; the original sample-size justification is not reported.

Finally, the record's arm-label ambiguity and incomplete reporting of outcomes, missing data, multiplicity, and analysis populations are not merely administrative details. They affect the confidence readers can place in the comparison and the extent to which it can be independently reproduced.

19. 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 registry record does not report participant characteristics beyond unexplained infertility and group sizes. Eligibility criteria, age distribution, infertility history, recruitment setting, and other baseline characteristics are not reported, limiting assessment of comparability and generalizability. The mapping of the control label is also unclear: the summary calls the no-injury group the control, but the control field identifies the endometrial-injury arm.

Important design details are absent. Randomization is stated, but sequence generation, allocation concealment, and the identity of masked participants or staff are not reported. The record does not provide a participant-flow diagram or outcome-specific analysis denominators. It is therefore unclear whether the listed group sizes represent everyone randomized, everyone followed, or everyone analyzed for each endpoint.

The analysis is not fully reproducible from the registry. The sponsor's exact estimates and test statistics are not reported, and the sponsor's threshold-form p-values differ from the unadjusted recalculations based on the posted summaries. The registry does not explain the differences or specify adjustments, analysis populations, missing-data methods, distributional checks, or sensitivity analyses. The original sample-size rationale, interim analyses, and detailed statistical plan are not reported in the registry record.

Only one secondary outcome is posted despite the record listing six outcome measures and six analyses. The other results, any multiplicity strategy, and the relationship between the primary and secondary outcomes are not reported. A clinically important difference for either endpoint is not specified. Safety reporting is limited to the listed counts, and deaths are not reported in the registry record.

These limitations do not erase the posted numbers, but they restrict the strength and scope of interpretation. They make it difficult to judge whether the analyses followed the original plan, whether missing observations could affect results, and how well findings apply beyond the described study groups.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Endometrial Injury for Unexplained Infertility — NCT02863198.
• Registry record last updated 2017-03-14; status last verified 2017-01.
• Results first posted 2017-03-14.
• 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.

23. Record Summary

The registry record describes a randomized, single-masked, parallel-group study of 120 women with unexplained infertility, with 60 assigned to endometrial injury and 60 to no injury. All participants received clomiphene citrate and human menopausal gonadotropin. The primary outcome was uterine artery pulsatility index at human chorionic gonadotropin administration.

The posted primary group means are 2.4 and 2.35. The unadjusted recalculated mean difference is -0.05, with a 95% confidence interval from -0.142 to 0.042 and p = 0.285; the registry reports p <0.05 for the sponsor's two-sided t-test. Pregnancy rate is the posted secondary outcome, and its sponsor-reported and recalculated significance summaries also differ.

The registry does not explain the discrepancies, resolve the control-arm labeling ambiguity, or report several details needed to evaluate analysis populations, missing data, multiplicity, and the original sample-size rationale. Serious and other adverse-event counts are recorded as zero in both groups; deaths are not reported in the registry record.