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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Office Hysteroscopy | Active Comparator | 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. |
|
| Saline Infusion Sonography (SIS) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Office hysteroscopy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | Immediately following imaging modality (less than 30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Complete | Length of time to complete procedure in minutes | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Moustafa, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Linnea Goodman, MD | University of North Carolina, Chapel Hill | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Fertility | Raleigh | North Carolina | 27616 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33527249 | Derived | Moustafa S, Rosen E, Goodman L. Patient and provider satisfaction with saline ultrasound versus office hysteroscopy for uterine cavity evaluation prior to in vitro fertilization: a randomized controlled trial. J Assist Reprod Genet. 2021 Mar;38(3):627-634. doi: 10.1007/s10815-021-02065-9. Epub 2021 Feb 1. |
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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.
Beginning 9 months and ending 3 years following article publication.
Investigator proposing to use data has IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC.
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| ID | Title | Description |
|---|---|---|
| FG000 | Office Hysteroscopy | 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. Office hysteroscopy: 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. |
| FG001 | Saline Infusion Sonography (SIS) | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Office Hysteroscopy | 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. Office hysteroscopy: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | units on a scale | Immediately following imaging modality (less than 30 minutes) |
|
From the time of office procedure through 30 days afterwards.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Office Hysteroscopy | 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. Office hysteroscopy: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Moustafa, MD | University of North Carolina at Chapel Hill | 919-908-0000 | sarah_moustafa@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2019 | Mar 8, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Randomized controlled trial comparing satisfaction between saline infusion sonography and office hysteroscopy for screening evaluation of the uterine cavity prior to embryo transfer.
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|
| Through study completion, up to 1 year |
| Time to Infertility Treatment | Number of days to achieve planned fertility treatment | Through study completion, up to 1 year |
| Positive Predictive Value of SIS | Number of Participants with SIS Findings, Validated by Subsequent Hysteroscopy | 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 | During the allotted procedure only |
| BG001 | Saline Infusion Sonography (SIS) | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | BMI data were missing for 5 participants in the SIS arm. | Mean | Standard Deviation | Kg/m^2 |
|
| Infertility Diagnosis | Count of Participants | Participants |
|
| Prior Uterine Surgery | Count of Participants | Participants |
|
| History of Uterine Pathology | Count of Participants | Participants |
|
| Vaginal Delivery History | Count of Participants | Participants |
|
| Number of Participants with Prior Cervical Surgery | Count of Participants | Participants |
|
| OG001 | Saline Infusion Sonography (SIS) | 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. |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | units on a scale | Immediately following imaging modality (less than 30 minutes) |
|
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | units on a scale | Immediately following imaging modality (less than 30 minutes) | Surveys analyzed | Surveys analyzed |
|
|
|
|
| Secondary | Time to Complete | Length of time to complete procedure in minutes | Posted | Mean | Standard Deviation | minutes | During the allotted procedure only |
|
|
|
|
| Secondary | Number of Patients Requiring Secondary Procedure | Number of patients requiring a secondary procedure, either for management of pathology or inability to complete initial procedure. | Posted | Count of Participants | Participants | Through study completion, up to 1 year |
|
|
|
|
| Secondary | Time to Infertility Treatment | Number of days to achieve planned fertility treatment | Number of Patients requiring secondary procedure was used instead to represent potential for treatment delay. This measure was abandoned and no data was collected, based on the following factors making it less reliable: (1) variability of ability to add a second procedure case on the same day (for patient and/or provider), and (2) presence of other uncontrollable factors contributing to fertility treatment delay | Posted | Through study completion, up to 1 year |
|
|
| Secondary | Positive Predictive Value of SIS | Number of Participants with SIS Findings, Validated by Subsequent Hysteroscopy | Reported for those participants with abnormal finding during SIS procedure | Posted | Count of Participants | Participants | Through study completion, up to 1 year |
|
|
|
| Secondary | Ability to Manage Pathology With Office Hysteroscopy | Number of participants with pathology on hysteroscopy successfully managed within same procedure | Participants with abnormal finding during office hysteroscopy | Posted | Count of Participants | Participants | During the allotted procedure only |
|
|
|
| Post-Hoc | Number of Participants With Pathology Found | Descriptive characterization of pathology identified for participants, if any, during procedure. | Posted | Count of Participants | Participants | During the allotted procedure only |
|
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Saline Infusion Sonography (SIS) | 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. | 0 | 50 | 0 | 50 | 0 | 50 |
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| White |
|
| Hispanic |
|
| Ovulatory dysfunction |
|
| Male factor |
|
| Tubal factor |
|
| Unexplained |
|
| Other |
|
| Polypectomy |
|
| Lysis of adhesions |
|
| Caesarean section |
|
| Other |
|
| None |
|
| Adhesions |
|
| Retained product |
|
| Uterine anomaly |
|
| Inconclusive |
|
| None |
|