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
Secondary identifying numbers N0375157911
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
01/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo 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) studiedSurgery: Transcervical Endometrial Resection (TCRE)
InterventionComparison between GnRH agonist leuporelin and GnRH antagonist Cetrorelix.
Intervention typeProcedure/Surgery
Primary outcome measure1. 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
Secondary outcome measuresNot provided at time of registration
Overall study start date31/10/2003
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants100
Key inclusion criteria100 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 criteria1. Women on hormonal medications within last 3 months
2. Uterine size more than 12 weeks
3. Previous TCRE
Date of first enrolment31/10/2003
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Shrewsbury & Telford Hospital NHS Trust
Shrewsbury
SY3 8XQ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Shrewsbury and Telford Research and Development Consortium (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2008 Yes No