Pre-ablation endometrial preparation: a comparison between GnRH agonist leuporelin and GnRH antagonist Cetrorelix. A Randomised Controlled Trial.

ISRCTN	ISRCTN14156709
DOI	https://doi.org/10.1186/ISRCTN14156709
Protocol serial number	N0375157911
Sponsor	Department of Health
Funder	Shrewsbury and Telford Research and Development Consortium (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr B Bentick
Scientific

Shrewsbury & Telford Hospital NHS Trust
Royal Shrewsbury Hospital
Mytton Oak Road
Shrewsbury
SY3 8XQ
United Kingdom

Phone	+44 (0)1743 261142
Email	Bernie.Bentick@rsh.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To compare the effects of GnRH antagonist Cetrorelix (Cetrocide) and GnRH agonist Leuprorelin (Prostap SR) injections for preoperative endometrial preparation, prior to Transcervical Endometrial Resection (TCRE)
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Transcervical Endometrial Resection (TCRE)
Intervention	Comparison between GnRH agonist leuporelin and GnRH antagonist Cetrorelix.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. Endometrial thickness as measured on trans-vaginal ultrasound (sagittal plane) on the day of operation 2. Histological assessment of "endometrial chippings" 3. Comparison of side effect profile 4. Operative difficulties 5. Overall patient satisfaction
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	100
Key inclusion criteria	100 eligible women will be identified from those already on the waiting list for Transcervical Endometrial Resection (TCRE). They will be suitable candidates for the procedure and those with submucous fibroid will not be excluded.
Key exclusion criteria	1. Women on hormonal medications within last 3 months 2. Uterine size more than 12 weeks 3. Previous TCRE
Date of first enrolment	31/10/2003
Date of final enrolment	31/12/2005

Shrewsbury & Telford Hospital NHS Trust

Shrewsbury
SY3 8XQ
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	01/09/2008		Yes	No