SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Device: Office hysteroscopy

• Registration Number: NCT04415489
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2019-12-06
• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-04
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2021-03
• Results First Submitted: 2021-03-17
• Results First Submitted QC: 2021-03-17
• Results First Posted: 2021-04-14
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Women aged 18 - 50
• Patients undergoing routine cavity evaluation for planned in vitro-fertilization cycles

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Office Hysteroscopy	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.

Primary Outcome Measures

Name	Time	Method
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).
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).

Secondary Outcome Measures

Name	Time	Method
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.
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
Time to Infertility Treatment	Through study completion, up to 1 year	Number of days to achieve planned fertility treatment
Ability to Manage Pathology With Office Hysteroscopy	During the allotted procedure only	Number of participants with pathology on hysteroscopy successfully managed within same procedure

Trial Locations

Locations (1)

UNC Fertility; 🇺🇸 Raleigh, North Carolina, United States