A placebo controlled trial of medical treatment of submucous fibroids with gonadotropin releasing hormone (GnRH) analogues prior to hysteroscopic resection.

ISRCTN	ISRCTN06560767
DOI	https://doi.org/10.1186/ISRCTN06560767
Protocol serial number	N0116148335
Sponsor	Department of Health
Funder	Kings College Hospital NHS Trust R&D Consortium (UK) - NHS R&D support funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr D Jurkovic
Scientific

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

Primary study design	Interventional
Study design	Double blind randomised placebo controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	gonadotropin releasing hormone (GnRH)
Primary outcome measure(s)	Added 18/08/10: Completeness of fibroid resection
Key secondary outcome measure(s)	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
Completion date	01/12/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	47
Key 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)
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/02/2003
Date of final enrolment	01/12/2006

Department of Obstetrics and Gynaecology

London
SE5 9RS
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2010		Yes	No