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
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