Vaginoscopy vs Traditional Hysteroscopy for Fibroids

Overseen By Carol-Anne VALLÉE, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Cervical stenosis, Pregnancy, Blood dyscrasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a randomized controlled trial take place in a fertility outpatient clinic in an academic hospital. Women between 18 and 52 years old requiring polypectomy or myomectomy by hysteroscopy morcellation for abnormal uterine bleeding or for fertility issue are included. The aim is to evaluate pain perception between vaginal and traditional hysteroscopy for hysteroscopic morcellation. The investigator's hypothesis is that pain perception is lower using vaginoscopy compared to traditional hysteroscopy.

Who Is on the Research Team?

Carole KAMGA-NGANDE, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for women aged 18-52 who need a polypectomy or myomectomy due to abnormal bleeding or fertility issues. They must have small polyps or fibroids previously diagnosed by hysteroscopy. Women with large fibroids, cervical stenosis, blood disorders, or pregnancy cannot participate.

Inclusion Criteria

Polyp or fibroid previously diagnosed by hysteroscopy

My polyp is smaller than 2 cm.

My fibroids are 4 cm or smaller in total if I have more than one.

Exclusion Criteria

Pregnancy

I have a narrowed cervical canal.

I have a blood disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either traditional hysteroscopy or vaginoscopy for hysteroscopic morcellation under intravenous sedation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain perception and complications immediately after the intervention

immediately after intervention

1 visit (in-person)

Long-term Follow-up

Participants are monitored for time to pregnancy and continuation of fertility treatment

up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• standard hysteroscopy
• vaginoscopy

Trial Overview The study compares pain levels between two procedures: vaginoscopy and traditional hysteroscopy during outpatient treatment of uterine conditions like fibroids. The hypothesis is that vaginoscopy causes less pain than the standard method.

How Is the Trial Designed?

Group I: Vaginoscopy Experimental Treatment 1 Intervention

morcellation hysteroscopy with only intravenous sedation

Group II: Standard hysteroscopy Active Control 1 Intervention

morcellation hysteroscopy with intravenous sedation and paracervical bloc

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Hologic, Inc.

Industry Sponsor

Trials

48

Recruited

59,900+