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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20663795
Publication citations
-
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.