Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
18/08/2010
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

Mr D Jurkovic

ORCID ID

Contact details

Department of Obstetrics and Gynaecology
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0116148335

Study information

Scientific title

Acronym

Study hypothesis

To evaluate whether pre-operative treatment with gonadotropin releasing hormone (GnRH) analogues prior to hysteroscopic resection of submucous fibroids increases the success of surgery.

Ethics approval

Not provided at time of registration

Study design

Double blind randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Gynaecological

Intervention

Women undergoing TCRM will be randomised to receive pre-operative treatment with gonadotropin releasing hormone (GnRH) or placebo.
The duration of follow up was 6 weeks, post operatively

Intervention type

Drug

Phase

Not Specified

Drug names

gonadotropin releasing hormone (GnRH)

Primary outcome measures

Added 18/08/10:
Completeness of fibroid resection

Secondary outcome measures

Added 18/08/10:
1. Duration of the TCRM
2. Fluid deficit recorded at TCRM
3. Resolution of symptoms post-operatively
4. Number of subsequent fibroid related operations

Overall trial start date

01/02/2003

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Added 18/08/10:
1. Women found to have submucous fibroids on three-dimensional saline infusion sonohysterography (3D SIS)
2. Removal of fibroids by hysteroscopic transcervical resection of myoma (TCRM)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

47 (added 18/08/10; see publication)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/02/2003

Recruitment end date

01/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Obstetrics and Gynaecology
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Kings College Hospital NHS Trust R&D Consortium (UK) - NHS R&D support funding

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20663795

Publication citations

  1. Results

    Mavrelos D, Ben-Nagi J, Davies A, Lee C, Salim R, Jurkovic D, The value of pre-operative treatment with GnRH analogues in women with submucous fibroids: a double-blind, placebo-controlled randomized trial., Hum. Reprod., 2010, 25, 9, 2264-2269, doi: 10.1093/humrep/deq188.

Additional files

Editorial Notes