SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04415489
• Other study ID #: 18-3077
• Status: Completed
• Phase: N/A
• Start date: December 6, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	UNC Fertility	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Immediately following imaging modality (less than 30 minutes)
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).	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).	Immediately following imaging modality (less than 30 minutes)
Secondary	Time to Complete	Length of time to complete procedure in 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.	Through study completion, up to 1 year
Secondary	Time to Infertility Treatment	Number of days to achieve planned fertility treatment	Through study completion, up to 1 year
Secondary	Positive Predictive Value of SIS	Number of Participants with SIS Findings, Validated by Subsequent Hysteroscopy	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	During the allotted procedure only