Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000714684
Ethics application status
Approved
Date submitted
28/10/2005
Date registered
4/11/2005
Date last updated
4/11/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Multi-Centre randomised controlled trial: Evaluation of Ovarian reserve following surgical treatment of endometriomas by excision or ablation.
Scientific title
A Multi-Centre randomised controlled trial: Evaluation of Ovarian reserve following surgical treatment of endometriomas by excision or ablation.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian endometriosis 864 0
Condition category
Condition code
Reproductive Health and Childbirth 931 931 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised study comparing two different surgical techniques for ovarian endometriosis designed to assess the ability to maintain ovarian function and to prevent recurrence of ovarian disease in the 6 months following surgery. No such study has ever been performed, though both surgical techniques are widely used. It is possible that the results from this study will give good evidence as to the benefit and risks from each surgical technique and provide our female patients with good evidence for their capacity for reproduction in the future.
Intervention code [1] 738 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1219 0
To determine what the impact is of two different laparoscopic surgical techniques for the treatment of deep ovarian endometriosis on the reserve of ovarian follicles.
Timepoint [1] 1219 0
Secondary outcome [1] 2215 0
Comparision of two different surgical techniques for the treatment of ovarian endometriomas.
Timepoint [1] 2215 0

Eligibility
Key inclusion criteria
1. Known or suspected endometriosis causing presentation 2. Ovarian endometriomas present where surgery has been recommended and agreed on 3. Able to give informed consent 4. Willing and able to attend hospital for 6 months of follow up visits.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Suspected diagnosis of gynaecological malignancies or precursors 2. Irregular periods (<21 days or >35 days) 3. Polycystic ovarian syndrome 4. Current pregnancy 5. Contra-indication or previous reaction to the use of gonadotropins.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central control randomisation of patient to on of two arms of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated permutated randomised block design. The randomisation design will be stratified for study centre, age and uni-/bilaterality of the endometriomas.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1028 0
Charities/Societies/Foundations
Name [1] 1028 0
Australian Gynaecological Endoscopic Society
Country [1] 1028 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
AGES
Address
Country
Australia
Secondary sponsor category [1] 892 0
None
Name [1] 892 0
N/A
Address [1] 892 0
Country [1] 892 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2330 0
Dept. of Endogynaecology, Royal Hospital for Women
Ethics committee address [1] 2330 0
Sydney
Ethics committee country [1] 2330 0
Australia
Date submitted for ethics approval [1] 2330 0
Approval date [1] 2330 0
Ethics approval number [1] 2330 0
Ethics committee name [2] 2331 0
Epworth Hospital
Ethics committee address [2] 2331 0
Melbourne
Ethics committee country [2] 2331 0
Australia
Date submitted for ethics approval [2] 2331 0
Approval date [2] 2331 0
Ethics approval number [2] 2331 0
Ethics committee name [3] 2332 0
Research Centre for Reproductive Health, University of Adelaide
Ethics committee address [3] 2332 0
Ethics committee country [3] 2332 0
Australia
Date submitted for ethics approval [3] 2332 0
Approval date [3] 2332 0
Ethics approval number [3] 2332 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35941 0
Address 35941 0
Country 35941 0
Phone 35941 0
Fax 35941 0
Email 35941 0
Contact person for public queries
Name 9927 0
Dr. Jason Abbott
Address 9927 0
Department of Endo-Gynaecology
Royal Hospital for Women
Level 2
Barker Street
Randwick NSW 2031
Country 9927 0
Australia
Phone 9927 0
+61 2 93826557
Fax 9927 0
+61 2 93826244
Email 9927 0
[email protected]
Contact person for scientific queries
Name 855 0
Dr. Stephen Lyons
Address 855 0
Royal Hospital for Women
Level 2
Barker Street
Randwick NSW 2031
Country 855 0
Australia
Phone 855 0
+61 2 93826557
Fax 855 0
+61 2 93826244
Email 855 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.