MedTrace Logo

SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF

NCT04415489 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-05-19

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Sarah Moustafa, MD · University of North Carolina, Chapel Hill

  • Linnea Goodman, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-06
Primary Completion
2020-12-01
Completion
2020-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04415489 on ClinicalTrials.gov