Condition category
Urological and Genital Diseases
Date applied
27/06/2007
Date assigned
27/06/2007
Last edited
02/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A.J.M. Bij de Vaate

ORCID ID

Contact details

Vrije University Medical Centre (VUMC)
Department of Obstetrics and Gynaecology
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
+31 (0)20 444 3613
m.bijdevaate@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Endometrial aspiration specimen quality after SIS

Study hypothesis

The specimen contains less evaluable endometrium after Saline Infusion Sonography (SIS) than before SIS.

Ethics approval

Ethics approval received from the local medical ethics committee (METc VUmc) on the 7th September 2005 (ref: 2005/46).

Study design

Randomised, single blinded, controlled, parallel group single centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Abnormal uterine bleeding, Saline Infusion Sonography (SIS), endometrial aspiration

Intervention

Saline Infusion Sonography (SIS) and endometrial aspiration are performed with the same catheter in one session. Patients are either allocated to aspiration and subsequent SIS, or to the reverse order.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Quality assessment of aspiration specimen by pathologist. Evaluation of the biopsy was performed by the pathologist immediately after taking the endometrial biopsy.

Secondary outcome measures

Reliability of video SIS-images. The SIS was performed in the same session and was recorded on video.

Overall trial start date

01/09/2006

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with abnormal uterine bleeding.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

120

Participant exclusion criteria

1. Pelvic Inflammatory Disease (PID)
2. Cervical cancer

Recruitment start date

01/09/2006

Recruitment end date

01/07/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Vrije University Medical Centre (VUMC)
Amsterdam
1081 HV
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

Department of Obstetrics and Gynaecology
Division of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl/english/

Funders

Funder type

Hospital/treatment centre

Funder name

Vrije University Medical Centre (VUMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes