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
Scientific
Shrewsbury & Telford Hospital NHS Trust
Royal Shrewsbury Hospital
Mytton Oak Road
Shrewsbury
SY3 8XQ
United Kingdom
| Phone | +44 (0)1743 261142 |
|---|---|
| Bernie.Bentick@rsh.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 31/10/2003 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Shrewsbury & Telford Hospital NHS Trust
Shrewsbury
SY3 8XQ
United Kingdom
SY3 8XQ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
