Clinical trial NCT04415489: SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF
Official title: SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Assisted Reproduction
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Immediately following imaging modality (less than 30 minutes)
measure: Pain Scores
timeFrame: Immediately following imaging modality (less than 30 minutes)
measure: Provider Satisfaction
timeFrame: Immediately following imaging modality (less than 30 minutes)
Secondary outcomes:
measure: Time to Complete
timeFrame: During the allotted procedure only
measure: Number of Patients Requiring Secondary Procedure
timeFrame: Through study completion, up to 1 year
measure: Time to Infertility Treatment
timeFrame: Through study completion, up to 1 year
measure: Positive Predictive Value of SIS
timeFrame: Through study completion, up to 1 year
measure: Ability to Manage Pathology With Office Hysteroscopy
timeFrame: During the allotted procedure only
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: UNC Fertility
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Sarah Moustafa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Linnea Goodman, MD
role: STUDY_CHAIR
References:
citation: 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.