---
title: Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic. A Randomized Trial
nct_id: NCT04373694
overall_status: UNKNOWN
phase: NA
sponsor: "Centre hospitalier de l'Université de Montréal (CHUM)"
study_type: INTERVENTIONAL
primary_condition: Leiomyoma of Uterus
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04373694.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04373694"
ct_last_update_post_date: 2023-01-12
last_seen_at: "2026-05-12T07:07:27.614Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic. A Randomized Trial

**Official Title:** Pain Perception During Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic: A Randomized Trial

**NCT ID:** [NCT04373694](https://clinicaltrials.gov/study/NCT04373694)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 78
- **Lead Sponsor:** Centre hospitalier de l'Université de Montréal (CHUM)
- **Collaborators:** Hologic, Inc.
- **Conditions:** Leiomyoma of Uterus
- **Start Date:** 2020-09-09
- **Completion Date:** 2024-12-31
- **CT.gov Last Update:** 2023-01-12

## Brief Summary

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.

## Detailed Description

78 participants will be randomised in two groups:

1. traditional hysteroscopy: under intravenous sedation, hysteroscopic morcellation is perform after speculum insertion, vaginal cleansing, and paracervical anesthesia with xylocain 1%.
2. Vaginal hysteroscopy: under intravenous sedation, hysteroscopic morcellation is perform after vaginal cleansing using vaginal distension with saline solution

In addition to pain perception, other outcomes includes: complication rates, time to continue fertility treatment, time to pregnancy

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 52 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* polyp or fibroid previously diagnosed by hysteroscopy
* polyp less than 2 cm
* submucosal fibroid (type 0 or 1 according to the 2011 FIGO uterine fibroid classification) less than 2 cm
* if more than 1 fibroid: total fibroid have to be less or equal 4 cm

Exclusion Criteria:

* cervical stenosis
* polyp or fibroid more than 2 cm
* pregnancy
* blood dyscrasia
```

## Arms

- **Standard hysteroscopy** (ACTIVE_COMPARATOR) — morcellation hysteroscopy with intravenous sedation and paracervical bloc
- **Vaginoscopy** (EXPERIMENTAL) — morcellation hysteroscopy with only intravenous sedation

## Interventions

- **vaginoscopy** (PROCEDURE) — vaginal distension with hysteroscope for hysteroscopy morcellation (without speculum or tenaculum forceps)
- **standard hysteroscopy** (PROCEDURE) — speculum, paracervical block before hysteroscopy morcellation

## Primary Outcomes

- **Difference in pain perception between vaginoscopy group and traditional hysteroscopy group** _(time frame: immediately after intervention)_ — 10 point visual analog pain scale: 0 for no pain to 10 for unbearable pain

## Secondary Outcomes

- **Difference in length of time of procedure between vaginoscopy group and traditional hysteroscopy group** _(time frame: immediately after intervention)_
- **Difference in proportion of vasovagal syncope between vaginoscopy group and traditional hysteroscopy group** _(time frame: immediately after surgery)_
- **Difference in proportion of uterine perforation between vaginoscopy group and traditional hysteroscopy group** _(time frame: immediatly after surgery)_
- **Difference in length of time to continue fertility treatment between vaginoscopy group and traditional hysteroscopy group** _(time frame: up to 1 year)_
- **Difference in length of time to pregnancy between vaginoscopy group and traditional hysteroscopy group** _(time frame: up to 1 year)_

## Locations (1)

- CHUM - Clinique Médecine et biologie de la reproduction, Montreal, Quebec, Canada

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.chum - clinique médecine et biologie de la reproduction|montreal|quebec|canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04373694.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04373694*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*