Endometrial aspiration before or after Saline Infusion Sonography (SIS) in case of abnormal uterine bleeding: effect on specimen quality

ISRCTN	ISRCTN43875039
DOI	https://doi.org/10.1186/ISRCTN43875039
Secondary identifying numbers	N/A

Submission date: 27/06/2007
Registration date: 27/06/2007
Last edited: 28/10/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A.J.M. Bij de Vaate
Scientific

Vrije University Medical Centre (VUMC)
Department of Obstetrics and Gynaecology
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands

Phone	+31 (0)20 444 3613
Email	m.bijdevaate@vumc.nl

Study information

Study design	Randomised, single blinded, controlled, parallel group single centre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Endometrial aspiration before or after Saline Infusion Sonography (SIS) in case of abnormal uterine bleeding: effect on specimen quality
Study acronym	Endometrial aspiration specimen quality after SIS
Study objectives	The specimen contains less evaluable endometrium after Saline Infusion Sonography (SIS) than before SIS.
Ethics approval(s)	Ethics approval received from the local medical ethics committee (METc VUmc) on the 7th September 2005 (ref: 2005/46).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/2006
Completion date	01/07/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	120
Total final enrolment	113
Key inclusion criteria	Patients with abnormal uterine bleeding.
Key exclusion criteria	1. Pelvic Inflammatory Disease (PID) 2. Cervical cancer
Date of first enrolment	01/09/2006
Date of final enrolment	01/07/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Vrije University Medical Centre (VUMC)

Amsterdam
1081 HV
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre

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

Website	http://www.vumc.nl/english/
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Hospital/treatment centre

Vrije University Medical Centre (VUMC) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		22/04/2008	28/10/2021	Yes	No

Editorial Notes

28/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.