SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

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.
    

Intervention name(s): Office hysteroscopy
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): LiNA OperaScope
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Assisted Reproduction