Skip to main content
OpenTrials
Completed

NCT Number: NCT04415489

SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNC Fertility

Raleigh, North Carolina, 27616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Office hysteroscopy

Device

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 names: LiNA OperaScope

Primary outcomes

  1. Patient Satisfaction

    Time frame: 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).

  2. Pain Scores

    Time frame: 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).

  3. Provider Satisfaction

    Time frame: 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).

Secondary outcomes

  1. Time to Complete

    Time frame: During the allotted procedure only

    Length of time to complete procedure in minutes

  2. Number of Patients Requiring Secondary Procedure

    Time frame: 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.

  3. Time to Infertility Treatment

    Time frame: Through study completion, up to 1 year

    Number of days to achieve planned fertility treatment

  4. Positive Predictive Value of SIS

    Time frame: Through study completion, up to 1 year

    Number of Participants with SIS Findings, Validated by Subsequent Hysteroscopy

  5. Ability to Manage Pathology With Office Hysteroscopy

    Time frame: During the allotted procedure only

    Number of participants with pathology on hysteroscopy successfully managed within same procedure

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 4, 2020
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.