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 HSG and Tubal Patency Study (NCT02146248), a na na study. The primary outcome is Number of Participants With Bilateral Tubal Patency as Assessed by HSG-follicular.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02146248 |
| Phase | NA |
| Condition | Tubal Patency |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Jeffrey Jensen |
| Results posted | Yes |
2. Clinical Question
Population
Women enrolled in a pilot study of tubal patency. The registry record lists 11 participants enrolled. Further eligibility criteria and details of the study population are not reported in the registry record.
Intervention
Hormonal contraceptive treatment with a combined oral contraceptive and DepoProvera, assessed in the context of repeated HSG examinations. The record describes HSG assessments before treatment and after treatment, although the full schedule is not reported in the registry record.
Comparator
There is no randomized or parallel control group. The study is listed as a single-group study with allocation and masking recorded as not applicable. The intended comparisons are within the study group across HSG assessments, not between independently assigned treatment groups.
Primary question
How often are both fallopian tubes assessed as patent on HSG performed in the follicular phase, and how might HSG findings relate to menstrual-cycle timing and hormonal contraceptive use? The registry record identifies bilateral tubal patency at the follicular-phase HSG as the primary endpoint. It does not report the endpoint count or result.
The study's background explains that HSG is used to assess whether the fallopian tubes are open and that an HSG finding of blockage may not always correspond to actual blockage. The investigators were interested in whether the timing of HSG in the menstrual cycle, or hormonal contraceptive use, could affect the appearance of patency. The study is also described as part of work toward developing a nonsurgical permanent contraception method. That broader method is a motivation for studying tubal patency; the registry record does not describe it as a treatment tested in this pilot.
Because this is a small, single-group pilot rather than a randomized comparison, its design is suited to describing observations across examinations, not establishing a treatment effect against a control group. The record does not report a primary endpoint result, so it does not establish how frequently bilateral patency was observed.
3. Trial Design
NCT02146248, titled “HSG and Tubal Patency Study,” is a completed pilot study listed under the condition Tubal Patency. The record gives a start date of 2014-05 and a primary completion date of 2015-01. Enrollment is listed as 11. The study phase is recorded as not applicable. Jeffrey Jensen is listed as the sponsor.
The design is identified as single-group, with allocation and masking recorded as not applicable and none, respectively. The study therefore does not have a randomized treatment-versus-control structure. Its listed group is “HSG Studies.” The interventions named in the record are a combined oral contraceptive and DepoProvera. The group description says that participants would receive both treatments and undergo repeated HSG assessments. It mentions two HSG studies before hormonal treatment, one after pill treatment, and further examinations depending on whether the tubes appear patent. The description is truncated, so the complete examination schedule and treatment sequence are not reported in the registry record.
The primary endpoint is the number of participants with bilateral tubal patency at the follicular-phase HSG. The record lists five outcome measures and one analysis, but does not include the primary endpoint result in the registry record for this analysis. It also does not report a detailed statistical analysis plan, a sample-size justification for the pilot, or the criteria used to decide whether tubes appeared patent.
The within-group sequence can provide descriptive observations at different examination points, but it does not by itself separate effects of treatment from changes over time, cycle timing, or other influences. There is no like-for-like control group. Accordingly, the design should be read as an exploratory assessment of HSG observations in a group undergoing repeated examinations, not as a controlled estimate of treatment efficacy.
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 | HSG Studies |
|---|---|
| STARTED | 11 |
| Enrolled | 11 |
| Uterine Sounding | 11 |
| HSG 1 | 10 |
| HSG 2 | 10 |
| HSG 3 | 9 |
| HSG 4 | 7 |
| HSG 5 | 1 |
| COMPLETED | 9 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | HSG Studies |
|---|---|
| Withdrawal by Subject | 2 |
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.
| Characteristic | Unit | HSG Studies |
|---|---|---|
| Participants analysed | 11 | |
| Age, Continuous | years | 34 (SD 5) |
| Sex: Female, Male: Female | Participants | 11 |
| Sex: Female, Male: Male | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 9 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 11 |
| Nulligravid | Participants | 6 |
| One or more births | Participants | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Bilateral Tubal Patency as Assessed by HSG-follicular, measured over follicular phase HSG.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with bilateral tubal patency assessed by HSG during the follicular phase. “Bilateral” means that the endpoint concerns patency in both tubes, rather than patency in either tube alone. The registry describes the endpoint as a count of participants and gives its timeframe as the follicular-phase HSG.
HSG is an imaging test used to assess whether the fallopian tubes are open. In the study background, the investigators note that tubes may appear blocked on HSG even when they are actually open. The study is motivated in part by the possibility that menstrual-cycle timing or hormonal contraception could affect whether tubes appear patent on the examination. This makes the HSG finding relevant to the study’s question about tubal patency as observed at different points in the study sequence.
A participant count is a direct way to report how many people meet the stated endpoint definition. To understand the result fully, a reader would also need the number assessed at that examination, the handling of unavailable or uninterpretable examinations, and an uncertainty estimate. Those details, along with the endpoint count itself, are not reported in the registry record. No rate or percentage should be inferred from the enrollment figure alone: enrollment does not establish how many participants completed the follicular-phase HSG or had an evaluable result.
The endpoint describes an HSG assessment, not a direct demonstration of fertility, successful contraception, or the performance of the nonsurgical method discussed in the background. Its interpretation is specific to the recorded imaging outcome and its timing.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies bilateral tubal patency at the follicular-phase HSG as the primary endpoint, but does not report how many participants met that endpoint. It also does not provide a denominator for the endpoint assessment or an uncertainty estimate. Consequently, the posted information does not establish the observed frequency of bilateral patency, how variable that estimate might be, or whether the study’s observations were consistent across participants.
The enrollment of 11 indicates that this was a small pilot. Even when a study reports a clear count, a small group generally leaves substantial uncertainty about how well the observed pattern represents a broader population. That general point does not supply an estimate for this study: the endpoint result itself is not reported in the registry record. Enrollment must not be substituted for the number with an evaluable HSG finding.
The single-group structure also limits what can be attributed to hormonal treatment. Repeated assessments in the same group may describe how HSG findings vary over the study sequence, but without a separate control group, observed changes cannot be cleanly distinguished from changes associated with timing, the passage of time, or other factors. The record does not report a randomized comparison or a treatment-effect estimate. It therefore cannot support a controlled causal conclusion about either contraceptive intervention.
The study background describes a concern that HSG may sometimes suggest blockage when tubes are actually open. The endpoint, however, is based on the HSG assessment. The registry record does not report an independent reference assessment that could establish whether any HSG classification was correct. Nor does it report enough detail to evaluate the criteria for calling a tube patent or the consistency of interpretation between assessors.
The available safety figures report zero participants with serious adverse events among 10 at risk in the listed group, and one participant with other adverse events among 10 at risk. These are descriptive counts for the registry’s recorded categories. They do not compensate for the absence of the primary efficacy-related endpoint result, and they should not be interpreted as a comprehensive account of tolerability beyond the reported categories and period.
Overall, the record describes the purpose, single-group structure, interventions, and primary endpoint of a completed pilot. It does not provide the outcome information needed to quantify bilateral patency or to assess the precision of that result. Statistical interpretation should therefore remain limited to the design and the reported safety counts rather than implying a finding about the primary question.
9. Statistical Methods Explained
What the endpoint count means. The primary outcome is a count of participants meeting a binary definition: bilateral tubal patency on follicular-phase HSG. A binary outcome has two possible classifications for each assessed participant under the stated definition: the endpoint is met or it is not met. A count is useful for describing how many participants fall into the endpoint category. To interpret that count, readers also need to know how many participants were assessed and how missing or uninterpretable examinations were handled. Those details are not reported in the registry record, and the count itself is not reported.
What a proportion and confidence interval would add. In general, a proportion expresses the number meeting an outcome relative to the number assessed. A confidence interval describes the uncertainty around an estimate under a statistical model and sampling assumptions. It is not a guarantee that the true value lies within the interval, nor does it correct for bias in study design or measurement. No endpoint proportion or confidence interval is reported in the registry record. Without the numerator and denominator, neither should be reconstructed from enrollment.
Within-group observations and causal interpretation. General statistical reasoning distinguishes description from causal comparison. Repeated observations in one group can describe findings at different examination points. But without a separate comparison group, a difference between examination points does not isolate the effect of treatment: time, examination timing, participant characteristics, and other influences may also matter. The study is listed as single-group, and the registry record does not report a randomized comparator or a treatment-effect analysis. The design therefore supports a descriptive reading rather than a controlled causal estimate.
Precision and pilot studies. A pilot can help characterize study procedures and generate observations for future research. In general, the precision of a binary outcome estimate depends on the number of participants with evaluable outcome data and on how the outcomes are distributed. A small enrollment can make estimates imprecise, but no numerical precision estimate can be made from enrollment alone. The record lists 11 enrolled; it does not report the number assessed for the primary endpoint or the endpoint result. A formal sample-size justification for this pilot is not reported in the registry record.
Planning illustrations are not observed power. The record describes planning illustrations based on a stated fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It distinguishes between participant counts per arm for non-time-to-event outcomes and total event counts for time-to-event outcomes. These are planning assumptions, not findings from the pilot, and no planning values are included in the registry record for this analysis. In general, such illustrations describe hypothetical sample sizes under specified assumptions; they do not establish the probability that this completed study detected an effect. They are not observed power. The two-arm planning assumptions also do not describe the actual single-group study design.
Over-dispersion and model choice. General statistical models for counts or binary outcomes rely on assumptions about how observations vary. Over-dispersion means that observed variability exceeds what a model assumes. When present, it can make standard errors too small and confidence intervals too narrow if ignored. The registry record does not report an over-dispersion assessment or a model-based analysis for this endpoint. Given the absence of the primary result and analysis details, no conclusion about model fit or uncertainty adjustment can be drawn.
Repeated assessments and dependence. In general, observations from the same participant are related rather than independent. Analyses of repeated measurements should account for this dependence if they combine measurements across time or examination points. The registry record describes multiple HSG assessments but does not report how any repeated measurements were analyzed, whether analyses were limited to particular visits, or how participant-level dependence was handled. The primary endpoint is tied to the follicular-phase examination, but the analysis details are not reported.
Statistical plan and interpretation. The record lists one analysis, but the statistical methods, prespecified hypotheses, treatment of missing values, and criteria for interpreting results are not reported in the registry record. A planned analysis and an analysis selected after results are known can have different interpretive implications; the record does not provide enough information to evaluate that distinction. No p-value, effect estimate, confidence interval, or test result for the primary endpoint is reported. Thus there is no basis for statistical significance testing or for a numerical estimate of the primary outcome from the posted information.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists five outcome measures and one analysis. It identifies bilateral tubal patency at the follicular-phase HSG as the primary endpoint. The record does not report a hierarchy for the other outcomes, whether they were confirmatory or exploratory, or whether any multiplicity adjustment was planned. Multiplicity matters in general when multiple outcomes or comparisons are tested: the more opportunities there are to identify a nominally unusual result, the more important it is to understand which analyses were prespecified and how results were interpreted. No such plan is reported, and the primary endpoint result is not available for interpretation.
Missing-data handling is also not reported in the registry record. In a repeated-HSG study, relevant details would include how many participants completed each assessment, why any assessment was unavailable or uninterpretable, and whether the primary analysis included only participants with an observed follicular-phase result. The enrollment count of 11 does not establish the denominator for the primary endpoint. No imputation method, sensitivity analysis, or missingness assumption is reported.
The analysis population is not described in sufficient detail to determine whether the endpoint was analyzed in all enrolled participants, only those completing specified examinations, or another defined group. The record does not report exclusions from analysis or the treatment of protocol deviations. These omissions limit assessment of selection bias and reproducibility. They do not show that missing data or multiplicity affected the findings; rather, the registry record does not give the information needed to assess those issues.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| HSG Studies | 0 | 10 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| HSG Studies | 1 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | HSG Studies |
|---|---|---|
| Pelvic Pain | Reproductive system and breast disorders | 1 of 10 |
For the listed “HSG Studies” group, the registry reports serious adverse events for 0 of 10 participants at risk and other adverse events for 1 of 10 participants at risk. These are participant counts in the registry’s event categories. They are not the number of distinct event episodes, and the two categories should not be combined into a new total.
The record lists no serious-event terms among the top serious terms. Deaths are not reported in the registry record. The safety figures apply to the group and risk denominator recorded for these outcomes; the registry record does not explain why the at-risk count is 10 while total enrollment is 11. It also does not provide a detailed observation period, event definitions, severity breakdown for other events, or a causal assessment attributing events to an intervention.
In general, a count of zero serious adverse events in a small group is a description of what was reported, not proof that serious harms are impossible or absent in other settings. Likewise, the count of one participant with an other adverse event does not by itself establish its cause or clinical importance. The figures should be read as limited registry summaries, not as a complete assessment of safety.
12. What the Result Does, and Does Not, Mean
The record establishes that NCT02146248 was a completed pilot of HSG assessments in a single group receiving hormonal contraceptive treatment. It identifies bilateral tubal patency at the follicular-phase HSG as the primary outcome and gives a rationale for studying whether cycle timing or hormonal contraception may affect how tubal patency appears on HSG.
The record does not report the primary endpoint count, its assessment denominator, or an estimate of uncertainty. It therefore does not show how many participants had bilateral patency at the specified examination, and it does not permit a quantitative assessment of the result. The enrollment figure is not a substitute for the unreported outcome.
The design also does not establish a treatment effect. There is no randomized control group, and the registry record does not report a treatment-effect estimate. Even if the outcome count were available, a within-group observation would not by itself separate the influence of treatment from timing or other changes across repeated examinations.
The study’s motivation includes developing a nonsurgical permanent contraception method, but that method is not described as an intervention in the listed study group. The primary endpoint is an HSG finding, not a direct measure of contraception effectiveness, fertility, or long-term clinical outcome. A finding about HSG-assessed patency should not be extended to those distinct questions without evidence that directly evaluates them.
The posted safety counts are limited to the reported adverse-event categories and at-risk group. They do not establish comprehensive safety, and they do not fill the gap in primary outcome reporting. The appropriate conclusion is narrow: the registry describes a pilot design and its intended question, but the outcome information needed to answer that question is not reported in the registry record.
13. Why This Trial Matters Statistically
This study raises a statistical issue that applies to diagnostic and imaging outcomes: the measured classification may depend on when and how it is assessed. The investigators’ stated concern is that an HSG may show apparent blockage even when a tube is open, and that menstrual-cycle timing or hormonal contraceptive use may affect the appearance. That makes the definition and timing of the endpoint central to interpretation, rather than incidental details.
Repeated assessments can be informative because they allow observations at different points in a participant’s course. They also create analytical challenges. Results from examinations on the same participant are related, and changes across visits can reflect more than treatment alone. A clear analysis needs to define which examination answers the primary question, how repeated measurements are handled, and how uninterpretable or missing assessments are treated. Those details are not reported in the registry record.
The single-group pilot design is another important feature. It can generate descriptive information, but it does not supply the independent comparison needed to attribute differences to hormonal treatment. The record’s planning assumptions refer to equal allocation between two arms, whereas the actual study is listed as single-group. That distinction matters: planning illustrations under a two-arm setup do not describe this study’s design or yield evidence of a treatment effect.
Finally, the absence of the primary endpoint result illustrates why a well-described research question is not enough to evaluate findings. Without the endpoint count, denominator, and uncertainty, readers cannot judge the observed frequency or its precision. The registry record still conveys the study’s motivation and structure, but its available outcome information does not answer the primary statistical question.
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 interpreting this study is that the registry record does not report the primary endpoint result. It gives neither the number of participants with bilateral tubal patency at the follicular-phase HSG nor the number assessed at that examination. This prevents calculation or evaluation of the outcome estimate and its precision.
Enrollment is 11, while the listed adverse-event risk denominator is 10. The record does not explain that difference. It should not be assumed that the adverse-event denominator is the primary endpoint denominator or that the remaining participant had a missing HSG result.
The design is single-group, with no randomized comparator. As a result, the study cannot isolate the effect of either hormonal contraceptive intervention from timing or other changes across repeated examinations. The arm description is incomplete, and the full sequence of HSG assessments is not reported in the registry record. This makes it difficult to determine exactly how observations were scheduled and how the primary examination related to the other assessments.
The registry record also does not report the HSG criteria for classifying patency, the number of interpretable examinations, assessor procedures, or an independent reference assessment. It is therefore not possible to evaluate classification consistency or confirm how well HSG findings corresponded to actual tubal patency in this study. Statistical details on missing data, analysis populations, and uncertainty estimates are also not reported.
Finally, the pilot’s stated motivation includes a broader contraception-development goal, but the listed endpoint is an HSG finding. The registry does not report outcomes that would directly establish performance of the nonsurgical method mentioned in the background. These limitations restrict conclusions to the study description and the safety counts that are reported.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: HSG and Tubal Patency Study — NCT02146248.
- Registry record last updated 2017-03-22; status last verified 2017-02.
- Results first posted 2017-02-20.
- 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.
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18. Record Summary
NCT02146248, “HSG and Tubal Patency Study,” is listed as a completed, single-group pilot with 11 participants enrolled. The study began in 2014-05 and reached primary completion in 2015-01. The listed interventions are a combined oral contraceptive and DepoProvera, with repeated HSG assessments described in the study group.
The primary endpoint is the number of participants with bilateral tubal patency at the follicular-phase HSG. The registry record does not report that endpoint result, its denominator, or an uncertainty estimate. It lists five outcome measures and one analysis, but the detailed statistical plan, missing-data handling, and analysis populations are not reported in the registry record.
For the listed group, 0 of 10 participants at risk had a reported serious adverse event, and 1 of 10 had a reported other adverse event. The record does not explain the difference between enrollment and the safety risk denominator. These summaries describe the registry entries and do not establish the primary outcome or a controlled treatment effect.