Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy

This will be a prospective single blinded randomized control trial to determine whether the
order of performance of office hysteroscopy (OH) and endometrial biopsy (EMB) during the same
office evaluation for abnormal uterine bleeding affects the patient's pain perception. We
also intend to investigate whether the order of the procedures affects the adequacy of the
endometrial sample, duration of the procedure, and optimal visualization of the uterine
cavity. We hypothesize that performing EMB prior to OH will result in higher patient pain
scores.

Included patients will be all consecutive female patients ages 18-70 presenting to the
University of South Florida Center for Endometriosis and Fibroid Treatment (CFERT) for
evaluation of abnormal uterine bleeding or uterine fibroids.

Patients will be randomly assigned to have either OH followed by EMB or EMB followed by OH as
part of their clinical assessment of AUB/uterine fibroid based on clinical indication. The
patients will be informed about the two indicated procedures by their clinical provider but
will be blinded to the order of performance. The healthcare provider/investigator will be
aware of the order in which the procedures are assigned and to be performed. Patients will be
consented to participate in the study prior to the procedure by the study team on the day the
indicated procedures are scheduled in CFERT. The healthcare provider performing the procedure
will open an unlabeled envelope, within which there will be a piece of paper indicating which
procedure is to be performed first. This will then be recorded in the study log. The study
log will include enrolled patients, assigned study number which will range from 001 to the
minimum number of patients required for the study as indicated by sample size calculation.

At the end of the procedures, patient will be asked to describe their pain perception based
on Visual analogue scale (VAS) from 0-10. The adequacy of the endometrial sample will be
determined from the pathology report. The duration of the entire procedures (min) will be
timed using a stopwatch from the time of insertion of the hysteroscope/Pipelle catheter in
the external cervical canal to removal of the instruments. A panoramic picture of the
endometrial cavity will be taken and will be given to a blinded independent reviewer to
determine the adequacy of visualization based on 3 point scoring system (fair, good and
excellent). Fair visualization will be defined as no tubal ostia visualized; good will be
defined as both tubal ostia identified but only able to visualize 180 degrees of panorama;
excellent visualization will be defined as visualizing bilateral tubal ostia and having a
clear image of the uterine cavity in 360 degrees of panorama.

Inclusion Criteria:

- All consecutive female patients ages 18-70 presenting to the Center for Fibroid and
Endometriosis Research and Treatment for medically indicated office hysteroscopy and
endometrial biopsy for evaluation of abnormal uterine bleeding and or uterine fibroids
with ability to provide written informed consent.

Exclusion Criteria:

- Patients unable to provide informed consent

- Patients presenting to the Center for Fibroid and Endometriosis Research and Treatment
for medically indicated office hysteroscopy and endometrial biopsy for evaluation of
abnormal uterine bleeding and or uterine fibroids are not deemed clinically indicated
based on the assessment of their clinical provider.

- Patients in which office hysteroscopy or endometrial biopsy is unsuccessful due to
patient discomfort, known cervical stenosis, or poor visualization of the cervix