Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome (NCT06684951), a randomized phase 4 study. The primary outcome is Serum Level of TNF-alfa,IL-10, for All Participants in Three Study Group at Day of Ova Pickup Compared to That at Day of Embryo Transfer.

2. Clinical Question

3. Trial Design

The registry describes a completed, randomized, double-masked, parallel-group phase 4 study. Its title concerns intrauterine flushing with hCG and ICSI outcome; the official title specifies low-dose hCG and ultrasound parameters and immunological markers of endometrial receptivity. The listed condition is female infertility. The sponsor is Omayma Ismail Khalaf.

The registered enrollment is 90. Group A is described as receiving an intrauterine infusion of 700IU hCG once immediately after ova pickup. Group B is described as receiving 500IU at the same time, and group C is described as receiving no treatment. The record does not explain how the randomized sequence was generated, how treatment assignment was concealed, or who was masked. It also does not clarify whether the no-treatment group underwent any procedure intended to preserve masking.

The study started on 2022-10-23, reached primary completion on 2024-01-23, and is marked completed. These dates describe the registered study timeline; they do not establish when outcome data were analyzed or reported.

The primary outcome is a continuous measure: serum levels of TNF-alfa and IL-10, described as means with standard deviations, assessed on the day of ova pickup and on the day of embryo transfer. A secondary outcome is listed as ICSI outcome. The record lists five outcome measures, but gives no numerical primary results, no detailed secondary results, and no statistical analyses. Further design details, including eligibility criteria and the planned analysis, are 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

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 Serum Level of TNF-alfa,IL-10, for All Participants in Three Study Group at Day of Ova Pickup Compared to That at Day of Embryo Transfer, measured over at day of ova pickup a blood sample aspirated, and on day of embryo transfer about 3-5 days post ova pickup blood sample taken within ten minute before embryo transfer to asses serum level of TNF-alfa and IL-10 for all participent.

The primary endpoint concerns serum levels of TNF-alfa and IL-10, reported in pg/ml. The record describes a blood sample on the day of ova pickup and a second sample on the day of embryo transfer. The stated sampling description places the first sample within 10 minute after ova pickup and the second ten minute before embryo transfer, which the record says occurs about 3-5 days post ova pickup.

These are continuous biological measurements. A mean describes the average observed level in a group; a standard deviation describes the spread of individual measurements around that mean. Tracking the markers at both occasions can describe how measured levels compare over the treatment period and between the registered groups. However, the registry record does not provide the group means, standard deviations, individual changes, or an estimated difference between groups. It therefore does not show the size or precision of any observed effect.

The title of the primary outcome refers to comparing levels at ova pickup with levels at embryo transfer for all participants in the three study groups. It does not specify a single contrast or a single summary value that would represent every possible comparison across markers, groups, and occasions. The record also does not give a rationale for selecting TNF-alfa and IL-10 as endpoints, describe a clinically meaningful change, or state how these laboratory measures relate to the listed secondary ICSI outcome. Those details are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, double-masked, parallel-group study. In a randomized trial, assignment is intended to make treatment groups comparable on average with respect to measured and unmeasured characteristics. Randomization does not guarantee that every group will have identical characteristics, particularly in a study of limited size. The registry record does not report the sequence-generation method, allocation concealment, or checks of baseline balance, so those aspects cannot be evaluated.

What does a parallel-group design mean?

In a parallel-group design, participants are assigned to a study group and receive that group’s assigned approach. The three registered approaches are 700IU hCG, 500IU hCG, and no treatment, each described in relation to the period immediately after ova pickup. The record does not say whether the no-treatment group received a placebo or a sham procedure. It also does not explain the masking procedures or identify who was masked. The label “double-masked” is recorded, but the practical implementation cannot be assessed from the available description.

How should a continuous endpoint be summarized?

TNF-alfa and IL-10 are measured as continuous serum levels in pg/ml. A mean gives a measure of the central level within a group; a standard deviation describes variability among the measurements. These summaries can help readers understand both typical levels and how widely observations vary. A difference in means can be used to describe a contrast, but the registry record supplies no means, standard deviations, or calculated contrasts for these markers.

Because the same participants are described as providing samples at ova pickup and embryo transfer, the observations may be related within a participant. A statistical analysis of change over time could account for that relationship, whereas treating every measurement as unrelated could misrepresent uncertainty. This is a general statistical consideration, not a statement about the analysis used in this study. The registry record does not report the model or method used to account for repeated measurements.

What does uncertainty around an estimate mean?

A confidence interval is a statistical range that represents uncertainty around an estimated quantity under a specified method and its assumptions. It can help show whether the data are compatible with a narrow range of effects or with a wider range. A p-value, when used, describes how unusual data at least as extreme as those observed would be under a specified null hypothesis and model. Neither a confidence interval nor a p-value by itself establishes clinical importance or removes concerns about bias. No confidence intervals or p-values for the primary outcome are reported in the registry record.

Why does the comparison need to be clearly specified?

The primary outcome includes two markers and measurements at two occasions across three groups. That structure permits multiple possible comparisons. A prespecified primary contrast helps make clear which estimate is intended to answer the main question and reduces the risk of selectively emphasizing a favorable result among many analyses. The registry record does not identify a single primary contrast, describe a multiplicity adjustment, or report an analysis plan.

The registry specifies means and standard deviations as the summary approach for the continuous endpoint, but does not describe distributional assumptions, transformations, covariate adjustment, or a method for handling repeated measures. If continuous data are strongly skewed or contain extreme values, a mean and standard deviation may not fully describe their distribution. That is a general limitation of these summaries; the record does not state whether it was relevant to these measurements.

How should planning illustrations be interpreted?

Sample-size illustrations based on an observed effect are planning calculations, not evidence that the study was designed with those assumptions and not a measure of observed power. The registry record says its sample-size assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the detectable effect expressed as a fraction of the observed effect. It does not report the trial’s own sample-size justification or design assumptions. In addition, the registered primary outcome spans several categories or time points and is not reduced to one comparison for recalculation. Any planning illustration therefore cannot replace the sponsor’s analysis or establish how adequately the trial was planned.

No statistical analysis is listed in the registry record. Consequently, the actual methods used to estimate treatment effects, quantify uncertainty, address missing data, or account for multiple outcomes are not reported. General descriptions of statistical methods explain how such analyses can work; they should not be mistaken for methods confirmed to have been used in this study.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome involves TNF-alfa and IL-10, with measurements at ova pickup and embryo transfer across three study groups. This creates several possible comparisons. When many hypotheses are tested, the chance of obtaining a seemingly notable result by chance can increase. Statistical approaches to multiplicity can adjust the interpretation or testing strategy, while a prespecified hierarchy can identify which comparison is primary. The registry record does not report a multiplicity strategy or identify one primary contrast.

The record lists ICSI outcome as a secondary outcome and states that there are five outcome measures, but it does not provide all measure definitions or numerical results. It does not explain whether secondary outcomes were exploratory, whether they were included in a testing hierarchy, or whether any adjustment was planned. These details are not reported in the registry record.

Missing data can affect interpretation if measurements are unavailable for some participants, particularly if the reasons for missingness differ between groups or relate to outcomes. The registry record does not report the amount or pattern of missing primary outcome data, how missing values were handled, or whether sensitivity analyses were conducted. It also does not state which analysis population was used, such as whether participants were analyzed according to randomized assignment.

The record lists zero analyses. It therefore provides no reported statistical analysis with which to assess the handling of multiplicity, missing data, or analysis populations. These gaps do not establish that such methods were omitted from the study itself; they mean that the methods are not reported in the registry record.

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 adverse-event figures list Group A, Group B, and Group C, with 30 at risk in each group. For each group, the reported serious-event count is 0, the other-event count is 0, and the death count is 0. These are the registry’s posted counts and should be read as recorded, rather than as a complete account of every possible safety outcome.

A zero count does not, on its own, show that an event was actively sought in the same way across all groups or that every participant had complete follow-up. The record does not report event definitions, the observation period, collection procedures, severity grading beyond the serious-event category, or whether participants were assessed for events at scheduled visits. It also does not provide narrative details about safety monitoring.

The figures therefore indicate that no serious or other events, and no deaths, were entered for these groups in the registry record. They do not quantify uncertainty around the underlying risk or establish that no adverse events occurred outside the information recorded. Safety interpretation should remain limited to these posted counts and the monitoring details that are not reported in the registry record.

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

This study addresses a specific timing and route of administration: intrauterine hCG flushing immediately after ova pickup in women undergoing ICSI. It compares two recorded hCG amounts with a no-treatment group and identifies serum TNF-alfa and IL-10 levels at ova pickup and embryo transfer as the primary outcome. That design makes the intended question clear at a broad level, while leaving important details of the comparison unspecified.

The registry record does not report the numerical primary outcome results or the statistical analyses. As a result, it cannot show whether the marker levels differed between groups or occasions, how large any difference was, or how precisely it was estimated. It also cannot establish whether the groups were similar, whether any apparent difference would be clinically meaningful, or whether any outcome was unchanged. No numerical ICSI outcome results are reported either.

The distinction between a missing result and a null result is important. A null result would require an analysis with an estimate and uncertainty that provides evidence about the range of effects compatible with the data. The absence of an estimate in the registry record does not provide that evidence. Nor does the registered status of completed establish that results were analyzed or made available in this record.

The safety figures are limited to the recorded counts of 0 serious events, 0 other events, and 0 deaths in each group. Without information about event definitions, ascertainment, and follow-up, these counts cannot describe all aspects of safety or rule out events that were not captured.

The appropriate conclusion is therefore about the record, not the efficacy or safety of a treatment: the trial’s registered design and intended endpoints are described, but its comparative clinical findings cannot be evaluated from the results reported in the registry record.

13. Why This Trial Matters Statistically

Statistically, the trial is notable for asking a question that combines three treatment groups, two cytokine markers, and measurements at separate occasions. The answer depends not only on the observed values but also on which contrast was intended to be primary, how repeated measurements were handled, and how multiple comparisons were interpreted. The registry record does not report those analysis details.

The design also makes clear why an endpoint’s definition matters. Measuring serum markers at ova pickup and embryo transfer can describe biological measurements over the study period, but the record does not give a prespecified numerical target, a clinically meaningful difference, or a stated link between marker changes and ICSI outcomes. Without these details and the observed estimates, readers cannot determine what a difference would mean for the broader clinical question.

Reporting the analysis plan and results would help distinguish the intended estimand from the many possible comparisons. Estimates with measures of uncertainty, clear denominators, and information about missing observations would allow readers to judge both the magnitude and reliability of findings. Reporting how randomization and masking were implemented would also make the design easier to evaluate.

The record currently supports a transparent account of the intervention groups, timing, and planned primary measurements, alongside limited posted safety counts. It does not support an assessment of comparative effects. This distinction is important for evidence synthesis: an unreported result should not be treated as a finding of no effect, and a planning illustration should not be treated as an observed treatment effect or observed power.

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 for interpretation is that the registry record does not report numerical primary outcome results or statistical analyses. Without these, effect estimates and their uncertainty cannot be assessed. The secondary ICSI outcome is named but is not accompanied by numerical findings or sufficient detail to understand its definition.

The primary outcome description covers two markers at two sampling occasions across three study groups but does not specify one primary contrast. The record does not explain whether the analysis was intended to compare groups at each occasion, changes within groups, or differences in change between groups. It also does not report how multiplicity was addressed or whether the analysis accounted for the relationship between repeated measurements from the same participants.

Important design and analysis information is absent. The registry record does not describe eligibility criteria in detail, baseline characteristics, allocation concealment, who was masked, the trial’s own sample-size justification, the statistical plan, analysis populations, or missing-data handling. It does not report whether participants were excluded from analyses after randomization or whether outcome measurements were complete.

The safety record reports zero serious events, other events, and deaths in each group, but does not describe event definitions, ascertainment, or follow-up. These counts therefore have limited interpretability beyond what was entered in the registry.

Finally, the registered outcome summary is not enough to determine the relationship between cytokine measurements, ultrasound parameters mentioned in the official title, and ICSI outcomes. Further endpoint definitions and results are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome — NCT06684951.
• Registry record last updated 2025-09-19; status last verified 2025-09.
• Results first posted 2025-04-27.
• 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

NCT06684951 is a completed randomized, double-masked, parallel-group phase 4 study of intrauterine hCG flushing after ova pickup in women undergoing ICSI. The registry lists an enrollment of 90 and describes groups assigned to 700IU hCG, 500IU hCG, or no treatment. The primary outcome concerns serum TNF-alfa and IL-10 levels at ova pickup and embryo transfer; ICSI outcome is listed as secondary.

The study started on 2022-10-23, with primary completion on 2024-01-23. The record lists five outcome measures and zero analyses. It reports no numerical primary or secondary results. The adverse-event entries report 0 serious events, 0 other events, and 0 deaths in each group. The registry record does not report the statistical plan, missing-data handling, or analysis populations.