NCT00870935

Brief Summary

The purpose of this study is:

  • to determine whether the choice of the device for performing hysterosalpingography on the basis of the cervix characteristics can reduce the procedure failure rate;
  • to determine whether patient medical history is correlated with the degree of pain experienced during the HSG procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

December 3, 2010

Status Verified

March 1, 2009

Enrollment Period

2 years

First QC Date

March 26, 2009

Last Update Submit

December 2, 2010

Conditions

Infertility

Keywords

Balloon catheterCervical vacuum cupHysterosalpingographyInfertilityPainFallopian Tube Patency TestsFemale Infertility

Outcome Measures

Primary Outcomes (1)

  • failure rate to complete hysterosalpingography (HSG)

    two years

Secondary Outcomes (11)

  • the objective difficulty to perform HSG

    two years

  • the subjective difficulty to perform HSG

    two years

  • the fluoroscopic time

    two years

  • the length of the procedure of device application

    two years

  • the volume of contrast medium used

    two years

  • +6 more secondary outcomes

Study Arms (3)

Balloon catheter

ACTIVE COMPARATOR

Hysterosalpingography using intrauterine Balloon catheter

Procedure: Balloon catheter

Cervical vacuum cup

ACTIVE COMPARATOR

Hysterosalpingography using cervical vacuum cup

Procedure: Cervical vacuum cup

Operator choice

EXPERIMENTAL

Hysterosalpingography is performed using either balloon catheter or cervical vacuum cup on the basis of the operator's choice

Procedure: Balloon catheterProcedure: Cervical vacuum cup

Interventions

Balloon catheterPROCEDURE

Hysterosalpingography is performed using intrauterine balloon catheter

Balloon catheterOperator choice
Cervical vacuum cupPROCEDURE

Hysterosalpingography is performed using cervical vacuum cup

Cervical vacuum cupOperator choice

Eligibility Criteria

Age25 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • infertility

You may not qualify if:

  • hypersensitivity to iodine or radio-opaque contrast dye
  • cervicitis
  • genital bleeding
  • genital malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, 3438, Italy

Location

MeSH Terms

Conditions

InfertilityPainInfertility, Female

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Giuseppe Ricci, MD

    IRCCS Burlo Garofolo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

August 1, 2007

Primary Completion

August 1, 2009

Study Completion

September 1, 2009

Last Updated

December 3, 2010

Record last verified: 2009-03

Locations

IT(1)