SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF: a Randomized Control Trial

Conditions
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Infertility

Intervention / Treatment
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* Device: Office hysteroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Office Hysteroscopy<br>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<br>* 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.<br>* Other names: LiNA OperaScope;|
| No Intervention: Saline Infusion Sonography (SIS)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Assisted Reproduction