Infertility
Conditions
Keywords
Assisted Reproduction
Brief summary
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.
Detailed description
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.
Interventions
DEVICEOffice 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.
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Randomized controlled trial comparing satisfaction between saline infusion sonography and office hysteroscopy for screening evaluation of the uterine cavity prior to embryo transfer.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 18 - 50 * Patients undergoing routine cavity evaluation for planned in vitro-fertilization cycles
Exclusion criteria
* Clinical or radiologic suspicion of intrauterine pathology including myomas, severe intrauterine adhesions or retained products of conception * Those with medical criteria not suitable office hysteroscopy due to requirement of advanced tools or preparation not available in the office such as history of bleeding disorder or medical co-morbidity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | Immediately following imaging modality (less than 30 minutes) | 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). |
| Pain Scores | Immediately following imaging modality (less than 30 minutes) | 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). |
| Provider Satisfaction | Immediately following imaging modality (less than 30 minutes) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive Predictive Value of SIS | Through study completion, up to 1 year | Number of Participants with SIS Findings, Validated by Subsequent Hysteroscopy |
| Time to Complete | During the allotted procedure only | Length of time to complete procedure in minutes |
| Ability to Manage Pathology With Office Hysteroscopy | During the allotted procedure only | Number of participants with pathology on hysteroscopy successfully managed within same procedure |
| Number of Patients Requiring Secondary Procedure | Through study completion, up to 1 year | Number of patients requiring a secondary procedure, either for management of pathology or inability to complete initial procedure. |
| Time to Infertility Treatment | Through study completion, up to 1 year | Number of days to achieve planned fertility treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Office Hysteroscopy | Total | Saline Infusion Sonography (SIS) |
|---|---|---|---|
| Age, Continuous | 33.9 years STANDARD_DEVIATION 4.6 | 34.3 years STANDARD_DEVIATION 4.8 | 34.7 years STANDARD_DEVIATION 4.9 |
| Body Mass Index (BMI) | 26.2 Kg/m^2 STANDARD_DEVIATION 6.4 | 26.9 Kg/m^2 STANDARD_DEVIATION 6.4 | 27.7 Kg/m^2 STANDARD_DEVIATION 6.4 |
| History of Uterine Pathology History of uterine pathology | 2 Participants | 6 Participants | 4 Participants |
| History of Uterine Pathology No history of uterine pathology | 48 Participants | 94 Participants | 46 Participants |
| Infertility Diagnosis Diminished ovarian reserve | 3 Participants | 10 Participants | 7 Participants |
| Infertility Diagnosis Endometriosis | 3 Participants | 4 Participants | 1 Participants |
| Infertility Diagnosis Male factor | 17 Participants | 27 Participants | 10 Participants |
| Infertility Diagnosis Other | 6 Participants | 14 Participants | 8 Participants |
| Infertility Diagnosis Ovulatory dysfunction | 10 Participants | 17 Participants | 7 Participants |
| Infertility Diagnosis Tubal factor | 1 Participants | 5 Participants | 4 Participants |
| Infertility Diagnosis Unexplained | 10 Participants | 23 Participants | 13 Participants |
| Number of Participants with Prior Cervical Surgery | 1 Participants | 2 Participants | 1 Participants |
| Prior Uterine Surgery Caesarean section | 7 Participants | 14 Participants | 7 Participants |
| Prior Uterine Surgery Dilation and curettage | 4 Participants | 13 Participants | 9 Participants |
| Prior Uterine Surgery Lysis of adhesions | 0 Participants | 0 Participants | 0 Participants |
| Prior Uterine Surgery Myomectomy | 4 Participants | 6 Participants | 2 Participants |
| Prior Uterine Surgery None | 34 Participants | 64 Participants | 30 Participants |
| Prior Uterine Surgery Other | 1 Participants | 1 Participants | 0 Participants |
| Prior Uterine Surgery Polypectomy | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 5 Participants | 11 Participants | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 42 Participants | 81 Participants | 39 Participants |
| Region of Enrollment United States | 50 Participants | 100 Participants | 50 Participants |
| Sex: Female, Male Female | 50 Participants | 100 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Vaginal Delivery History No prior Vaginal Delivery | 41 Participants | 80 Participants | 39 Participants |
| Vaginal Delivery History Prior Vaginal Delivery | 9 Participants | 20 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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).
Time frame: Immediately following imaging modality (less than 30 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Office Hysteroscopy | Pain Scores | 3.38 units on a scale | Standard Deviation 1.85 |
| Saline Infusion Sonography (SIS) | Pain Scores | 2.44 units on a scale | Standard Deviation 1.64 |
p-value: <0.01t-test, 2 sided
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).
Time frame: Immediately following imaging modality (less than 30 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Office Hysteroscopy | Patient Satisfaction | 4.92 units on a scale | Standard Deviation 0.34 |
| Saline Infusion Sonography (SIS) | Patient Satisfaction | 4.84 units on a scale | Standard Deviation 4.7 |
p-value: 0.57Fisher Exact
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).
Time frame: Immediately following imaging modality (less than 30 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Office Hysteroscopy | Provider Satisfaction | 4.76 units on a scale | Standard Deviation 0.69 |
| Saline Infusion Sonography (SIS) | Provider Satisfaction | 4.56 units on a scale | Standard Deviation 0.81 |
p-value: 0.11Fisher Exact
Secondary
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
Population: Participants with abnormal finding during office hysteroscopy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Office Hysteroscopy | Ability to Manage Pathology With Office Hysteroscopy | 16 Participants |
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.
Time frame: Through study completion, up to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Office Hysteroscopy | Number of Patients Requiring Secondary Procedure | 1 Participants |
| Saline Infusion Sonography (SIS) | Number of Patients Requiring Secondary Procedure | 11 Participants |
p-value: <0.01Fisher Exact
Secondary
Positive Predictive Value of SIS
Number of Participants with SIS Findings, Validated by Subsequent Hysteroscopy
Time frame: Through study completion, up to 1 year
Population: Reported for those participants with abnormal finding during SIS procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Office Hysteroscopy | Positive Predictive Value of SIS | 9 Participants |
Secondary
Time to Complete
Length of time to complete procedure in minutes
Time frame: During the allotted procedure only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Office Hysteroscopy | Time to Complete | 4.61 minutes | Standard Deviation 2.42 |
| Saline Infusion Sonography (SIS) | Time to Complete | 3.98 minutes | Standard Deviation 2.03 |
p-value: 0.16t-test, 2 sided
Secondary
Time to Infertility Treatment
Number of days to achieve planned fertility treatment
Time frame: Through study completion, up to 1 year
Population: 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
Post Hoc
Number of Participants With Pathology Found
Descriptive characterization of pathology identified for participants, if any, during procedure.
Time frame: During the allotted procedure only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Office Hysteroscopy | Number of Participants With Pathology Found | Adhesions | 2 Participants |
| Office Hysteroscopy | Number of Participants With Pathology Found | Uterine anomaly | 2 Participants |
| Office Hysteroscopy | Number of Participants With Pathology Found | Myoma | 0 Participants |
| Office Hysteroscopy | Number of Participants With Pathology Found | Inconclusive | 0 Participants |
| Office Hysteroscopy | Number of Participants With Pathology Found | Retained product | 5 Participants |
| Office Hysteroscopy | Number of Participants With Pathology Found | None | 31 Participants |
| Office Hysteroscopy | Number of Participants With Pathology Found | Polyps | 10 Participants |
| Saline Infusion Sonography (SIS) | Number of Participants With Pathology Found | None | 38 Participants |
| Saline Infusion Sonography (SIS) | Number of Participants With Pathology Found | Polyps | 7 Participants |
| Saline Infusion Sonography (SIS) | Number of Participants With Pathology Found | Myoma | 1 Participants |
| Saline Infusion Sonography (SIS) | Number of Participants With Pathology Found | Adhesions | 2 Participants |
| Saline Infusion Sonography (SIS) | Number of Participants With Pathology Found | Retained product | 1 Participants |
| Saline Infusion Sonography (SIS) | Number of Participants With Pathology Found | Uterine anomaly | 0 Participants |
| Saline Infusion Sonography (SIS) | Number of Participants With Pathology Found | Inconclusive | 1 Participants |
p-value: 0.12Fisher Exact