Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000523404
Ethics application status
Approved
Date submitted
6/08/2007
Date registered
11/10/2007
Date last updated
11/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Measuring ovarian reserve in women having laparoscopic surgery.
Scientific title
Anti-Mullerian Hormone measurement as a measure of ovarian reserve in women having a unilateral ovarian cystectomy
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reduced ovarian reserve (depletion of oocytes in the ovary). 2445 0
Condition category
Condition code
Reproductive Health and Childbirth 2549 2549 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Ovarian reserve is an estimate of the number of oocytes in the ovary. Anti-mullerian Hormone is thought to be one of the best measures of ovarian reserve. Despite this the assay is not widely available and Adelaide is the only city in Australia that provides this test mainly in a research setting. It is not routinely used to assess ovarian reserve after ovarian surgery.
A blood test for Anti-mullerian hormone will be taken immediately prior to surgery then at 6 weeks and 3 months after surgery.
Intervention code [1] 2175 0
Not applicable
Comparator / control treatment
Women who have laparoscopic surgery that does not involve ovarian surgery and a blood test will be taken immediately before surgery and again at 6 weeks and 3 months after.
Control group
Active

Outcomes
Primary outcome [1] 3454 0
Anti-Mullerian Hormone levels in serum
Timepoint [1] 3454 0
Immediately before surgery as baseline then at 6 weeks and 3 months after the operation
Secondary outcome [1] 5751 0
None
Timepoint [1] 5751 0
N/A

Eligibility
Key inclusion criteria
1)women with regular natural menstrual cycles or on COC contraceptive
Women on the combined oral contraceptive can be included as recent data shows that AMH levels are not altered by the pill.
2)women undergoing an laparoscopic gynaecological procedure.
The inclusion criteria has been modified to include women more than 13 years of age who are having natural menstrual cycles and can give informed assent with parental consent.
Minimum age
13 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) women unable or unwilling to independently give informed consent to participate in this study.
2)Women on medications that interfere with AMH levels.
3)Women with polycystic ovarian syndrome (AMH levels are high)
4)Women with malignant pathology.
5)Women who are deemed unsuitable to participate in this study as assessed by their lead clinician.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2694 0
Hospital
Name [1] 2694 0
Womens and Childrens Hospital Foundation Grant
Country [1] 2694 0
Australia
Primary sponsor type
Hospital
Name
WCH Foundation Grant
Address
72 King Williams Rd, North Adelaide, 5006
Country
Australia
Secondary sponsor category [1] 2438 0
None
Name [1] 2438 0
Address [1] 2438 0
Country [1] 2438 0
Other collaborator category [1] 68 0
Individual
Name [1] 68 0
Dr Alison Munt - O and G registrar
Address [1] 68 0
Lyell McEwen Hospital
Elizabeth , S.A.
Country [1] 68 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4614 0
Central and North Western Human Ethics Committee (Lyell McEwen)
Ethics committee address [1] 4614 0
Ethics committee country [1] 4614 0
Australia
Date submitted for ethics approval [1] 4614 0
Approval date [1] 4614 0
Ethics approval number [1] 4614 0
Ethics committee name [2] 4615 0
Childrens, Youth and Womens hospital service human ethics committee
Ethics committee address [2] 4615 0
Ethics committee country [2] 4615 0
Australia
Date submitted for ethics approval [2] 4615 0
Approval date [2] 4615 0
Ethics approval number [2] 4615 0

Summary
Brief summary
Informed consent obtained to take blood tests for AMH level estimation before surgery andat 2 time points afterwards
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27745 0
Address 27745 0
Country 27745 0
Phone 27745 0
Fax 27745 0
Email 27745 0
Contact person for public queries
Name 11120 0
Dr M. Louise Hull
Address 11120 0
University of Adelaide
Medical School North
Frome Road
Adelaide SA 5006
Country 11120 0
Australia
Phone 11120 0
+61 8 8333 -8111 (mob 0403 933 312)
Fax 11120 0
Email 11120 0
[email protected]
Contact person for scientific queries
Name 2048 0
Dr M. Louise Hull
Address 2048 0
University of Adelaide
Medical School North
Frome Road
Adelaide SA 5006
Country 2048 0
Australia
Phone 2048 0
+61 8 8333 -8111 (mob 0403 933 312)
Fax 2048 0
Email 2048 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.