An interventional study of Office hysteroscopy in Infertility, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-19.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Diagnostic
Saline infusion sonography (SIS) and hysteroscopy are commonly employed methods for uterine cavity evaluation. While hysteroscopy is regarded as the gold standard for diagnosis of intra-uterine pathology, it is not often used as an initial screening tool because of provider concerns about in-office tolerability, operating room costs, and use of anesthesia. The investigators aim to compare SIS and office hysteroscopy with respect to patient and provider satisfaction. Additionally, the investigators aim to assess the capability of office-based hysteroscopy to manage intra-uterine pathology at the time of diagnosis and reduce delays and supernumerary procedures.
Saline infusion sonography (SIS) and hysteroscopy are commonly employed methods for uterine cavity evaluation. SIS is often performed as a screening tool in the office for uterine evaluation since it is straight-forward to perform, well-tolerated has low overhead cost. If uterine pathology is suspected on SIS, subsequent hysteroscopy is typically performed in the operating room. Hysteroscopy remains the gold standard for diagnosis of intra-uterine pathology and offers the opportunity for intervention at time of diagnosis, but often is not used as the initial screening tool because of provider concerns about in-office tolerability, equipment cost and maintenance. Technology advancements, however, has introduced an affordable, disposable, small caliber hysteroscopes with an operative channel to make it possible for this type of assessment to be performed in the office setting with the addition of a 'see and treat' modality. If used to perform initial uterine cavity evaluation, hysteroscopy may offer expedited diagnosis, treatment, and avoidance of general anesthesia. If superior specificity is demonstrated, it may also lower the false positive rate, preventing unnecessary delays to a patient's projected treatment plan, and unnecessary exposure to anesthesia risks. To date, no randomized control trials have compared the satisfaction of patients and providers to saline infusion sonography versus office hysteroscopy without anesthesia in initial cavity evaluation with the ability to immediately address intra-uterine pathology.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 100 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
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Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
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Exclusion Criteria:
Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.
Device: Office hysteroscopy
This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.
Also known as: LiNA OperaScope
Patient Satisfaction
Survey with Likert scale administered to record patients overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).
Time frame: Immediately following imaging modality (less than 30 minutes)
Pain Scores
Survey administered to record patients pain scores during their procedure. Score range is 1-10, with one being minimal pain (better) and 10 being the worst pain ever experienced (worse).
Time frame: Immediately following imaging modality (less than 30 minutes)
Provider Satisfaction
Survey with Likert scale administered to record providers overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).
Time frame: Immediately following imaging modality (less than 30 minutes)
Time to Complete
Length of time to complete procedure in minutes
Time frame: During the allotted procedure only
Number of Patients Requiring Secondary Procedure
Number of patients requiring a secondary procedure, either for management of pathology or inability to complete initial procedure.
Time frame: Through study completion, up to 1 year
Time to Infertility Treatment
Number of days to achieve planned fertility treatment
Time frame: Through study completion, up to 1 year
Positive Predictive Value of SIS
Number of Participants with SIS Findings, Validated by Subsequent Hysteroscopy
Time frame: Through study completion, up to 1 year
Ability to Manage Pathology With Office Hysteroscopy
Number of participants with pathology on hysteroscopy successfully managed within same procedure
Time frame: During the allotted procedure only
| Milestone | Office Hysteroscopy | Saline Infusion Sonography (SIS) |
|---|---|---|
| Started | 50 | 50 |
| Completed | 50 | 50 |
| Not completed | 0 | 0 |
Survey with Likert scale administered to record patients overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).
| units on a scale | Office Hysteroscopy | Saline Infusion Sonography (SIS) |
|---|---|---|
| Patient Satisfaction | 4.92 ± 0.34 | 4.84 ± 4.7 |
Survey administered to record patients pain scores during their procedure. Score range is 1-10, with one being minimal pain (better) and 10 being the worst pain ever experienced (worse).
| units on a scale | Office Hysteroscopy | Saline Infusion Sonography (SIS) |
|---|---|---|
| Pain Scores | 3.38 ± 1.85 | 2.44 ± 1.64 |
Survey with Likert scale administered to record providers overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).
| units on a scale | Office Hysteroscopy | Saline Infusion Sonography (SIS) |
|---|---|---|
| Provider Satisfaction | 4.76 ± 0.69 | 4.56 ± 0.81 |
Length of time to complete procedure in minutes
| minutes | Office Hysteroscopy | Saline Infusion Sonography (SIS) |
|---|---|---|
| Time to Complete | 4.61 ± 2.42 | 3.98 ± 2.03 |
Number of patients requiring a secondary procedure, either for management of pathology or inability to complete initial procedure.
| Participants | Office Hysteroscopy | Saline Infusion Sonography (SIS) |
|---|---|---|
| Number of Patients Requiring Secondary Procedure | 1 | 11 |
Number of days to achieve planned fertility treatment
No measurements were reported for this outcome.
Number of Participants with SIS Findings, Validated by Subsequent Hysteroscopy
| Participants | Saline Infusion Sonography (SIS) |
|---|---|
| Positive Predictive Value of SIS | 9 |
Number of participants with pathology on hysteroscopy successfully managed within same procedure
| Participants | Office Hysteroscopy |
|---|---|
| Ability to Manage Pathology With Office Hysteroscopy | 16 |
Descriptive characterization of pathology identified for participants, if any, during procedure.
| Participants | Office Hysteroscopy | Saline Infusion Sonography (SIS) |
|---|---|---|
| Polyps | 10 | 7 |
| Myoma | 0 | 1 |
| Adhesions | 2 | 2 |
| Retained product | 5 | 1 |
| Uterine anomaly | 2 | 0 |
| Inconclusive | 0 | 1 |
| None | 31 | 38 |
Collected over From the time of office procedure through 30 days afterwards.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Office Hysteroscopy | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Saline Infusion Sonography (SIS) | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Continuous(years) | Office Hysteroscopy | Saline Infusion Sonography (SIS) | Total |
|---|---|---|---|
| Mean | 33.9 ± 4.6 | 34.7 ± 4.9 | 34.3 ± 4.8 |
| Sex: Female, Male(Participants) | Office Hysteroscopy | Saline Infusion Sonography (SIS) | Total |
|---|---|---|---|
| Female | 50 | 50 | 100 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Office Hysteroscopy | Saline Infusion Sonography (SIS) | Total |
|---|---|---|---|
| Race/Ethnicity — Asian | 3 | 1 | 4 |
| Race/Ethnicity — Black or African American | 5 | 6 | 11 |
| Race/Ethnicity — White | 42 | 39 | 81 |
| Race/Ethnicity — Hispanic | 0 | 4 | 4 |
| Region of Enrollment(Participants) | Office Hysteroscopy | Saline Infusion Sonography (SIS) | Total |
|---|---|---|---|
| United States | 50 | 50 | 100 |
| Body Mass Index (BMI)(Kg/m^2) | Office Hysteroscopy | Saline Infusion Sonography (SIS) | Total |
|---|---|---|---|
| Mean | 26.2 ± 6.4 | 27.7 ± 6.4 | 26.9 ± 6.4 |
| Infertility Diagnosis(Participants) | Office Hysteroscopy | Saline Infusion Sonography (SIS) | Total |
|---|---|---|---|
| Diminished ovarian reserve | 3 | 7 | 10 |
| Endometriosis | 3 | 1 | 4 |
| Ovulatory dysfunction | 10 | 7 | 17 |
| Male factor | 17 | 10 | 27 |
| Tubal factor | 1 | 4 | 5 |
| Unexplained | 10 | 13 | 23 |
| Other | 6 | 8 | 14 |
| Prior Uterine Surgery(Participants) | Office Hysteroscopy | Saline Infusion Sonography (SIS) | Total |
|---|---|---|---|
| Dilation and curettage | 4 | 9 | 13 |
| Myomectomy | 4 | 2 | 6 |
| Polypectomy | 0 | 2 | 2 |
| Lysis of adhesions | 0 | 0 | 0 |
| Caesarean section | 7 | 7 | 14 |
| Other | 1 | 0 | 1 |
| None | 34 | 30 | 64 |
| History of Uterine Pathology(Participants) | Office Hysteroscopy | Saline Infusion Sonography (SIS) | Total |
|---|---|---|---|
| History of uterine pathology | 2 | 4 | 6 |
| No history of uterine pathology | 48 | 46 | 94 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting information: Study protocol, Sap, Icf, Analytic code
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill