Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000326291
Ethics application status
Approved
Date submitted
9/12/2008
Date registered
21/05/2009
Date last updated
8/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of acupuncture on egg quality of women with a poor response to IVF treatment
Scientific title
The effect of acupuncture on ovarian blood flow and follicular health among "In Vitro Fertilisation (IVF) poor responders": a pilot study
Secondary ID [1] 252178 0
Acupuncture for poor IVF responders
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 4103 0
Condition category
Condition code
Reproductive Health and Childbirth 4297 4297 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupuncture will be administered to lower abdomen, arms, hands, lower legs and feet. Participants will receive 3 acupuncture treatments over the IVF cycle - day 2, day 7 and on the day of Human Chorionic Gonadotropin (hCG) administration. Each treatment is 40 minutes in duration. The women first undergo IVF without having acupuncture and therefore act as their own controls. The duration between the normal IVF treatment and the IVF treatment with acupuncture is 1 month.
Intervention code [1] 4610 0
Treatment: Other
Comparator / control treatment
Active control. Standard IVF treatment using the clinic protocol for stimulation with GnRH Antagonist will be administered. IVF treatment will vary with the individual and the clinicians' decision.
Control group
Active

Outcomes
Primary outcome [1] 5186 0
Improved peri-follicular blood flow will be measured using dopplar ultrasound
Timepoint [1] 5186 0
Day 16 of IVF cycle (without acupuncture), Day 16 of IVF cycle (with acupuncture)
Primary outcome [2] 5187 0
Reduced follicular fluid Vascular Endothelial Growth Factor (VEGF) will be measured by levels of aspirated follicular fluid
Timepoint [2] 5187 0
Day 16 of IVF cycle (without acupuncture), Day 16 of IVF cycle (with acupuncture)
Primary outcome [3] 5188 0
Improved granulosa cell function measured by level of aspirated follicular fluid anti-mullerian hormone
Timepoint [3] 5188 0
Day 16 of IVF cycle (without acupuncture), Day 16 of IVF cycle (with acupuncture)
Secondary outcome [1] 8735 0
Number of follicles > or = to 14mm on day of hCG administration as measured by an ultrasound
Timepoint [1] 8735 0
Day 16 of IVF cycle (without acupuncture), Day 16 of IVF cycle (with acupuncture)
Secondary outcome [2] 8736 0
Number of mature oocytes retrieved as measured by a blood test and an ultrasound
Timepoint [2] 8736 0
Day 16 of IVF cycle (without acupuncture), Day 16 of IVF cycle (with acupuncture)
Secondary outcome [3] 8737 0
Number of good quality embryos available for transfer/cyropreservation as measured by an embyologist
Timepoint [3] 8737 0
Day 16 of IVF cycle (without acupuncture), Day 16 of IVF cycle (with acupuncture)

Eligibility
Key inclusion criteria
Women aged < 43 years
"a poor responder" i.e. producing less than 4 oocytes
undergoing an antagonist cycle
Minimum age
18 Years
Maximum age
43 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of any drug that can affect follicular blood flow e.g. Non-Steroidal Anti-inflammatory Drugs (NSAIDS), current smoker, or use of anti-hypertensives.
Unable to attend for the allocated acupuncture sessions
Planning to use acupuncture during their next IVF cycle

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Women act as their own control
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
15/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1345 0
5005

Funding & Sponsors
Funding source category [1] 4267 0
Charities/Societies/Foundations
Name [1] 4267 0
Australian Acupuncture and Chinese Medicien Association
Country [1] 4267 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bag 1797
Penrith South DC NSW 1797
Country
Australia
Secondary sponsor category [1] 3839 0
None
Name [1] 3839 0
Address [1] 3839 0
Country [1] 3839 0
Australia
Secondary sponsor category [2] 4133 0
None
Name [2] 4133 0
Address [2] 4133 0
Country [2] 4133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6318 0
Children, Youth and Women's Health Service (CYWHS)
Ethics committee address [1] 6318 0
Children Youth and Women's Health Service
Regional Office
Level 2
77 King William Road
North Adelaide SA 5006
Ethics committee country [1] 6318 0
Australia
Date submitted for ethics approval [1] 6318 0
Approval date [1] 6318 0
17/04/2009
Ethics approval number [1] 6318 0
REC 2081/7/2011
Ethics committee name [2] 7074 0
Child and Youth and women's health services, Adelaide
Ethics committee address [2] 7074 0
Women's and Children's Hospital, Research Secretariat, 72 King William Road, North Adelaide, SA 5006
Ethics committee country [2] 7074 0
Australia
Date submitted for ethics approval [2] 7074 0
Approval date [2] 7074 0
17/04/2009
Ethics approval number [2] 7074 0
REC2081/7/11

Summary
Brief summary
Women who respond poorly to ovarian stimulation in an IVF cycle have been shown to have compromised blood flow to their ovarian follicles when compared to women with normal ovarian responses. Research suggests acupuncture may exert a sympatho-inhibitory effect reducing uterine artery impedance and thereby increase ovarian blood flow and subsequently follicular health among women with poor response to IVF treatment. The pilot study will recruit 20 women with a history of poor response to IVF. The methodology with involve experimental design with subjects acting as their own self control. The study will include an initial baseline measurement of study outcomes during a normal IVF cycle, and secondly, an acupuncture intervention, followed by measurement of outcomes of oocyte retrieval. The acupuncture diagnosis and treatment will follow an algorithm, and three acupuncture treatments will be administered prior to egg retrieval. The effects of blood flow and the follicle will be assessed by changes from baseline to egg retrieval, as measured by: peri-follicular blood flow, levels of follicular fluid VEGF, and level of follicular fluid anti-mullerian hormone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35023 0
Address 35023 0
Country 35023 0
Phone 35023 0
Fax 35023 0
Email 35023 0
Contact person for public queries
Name 12370 0
Associate Professor Caroline Smith
Address 12370 0
Centre for Complementary Research
Locked Bag 1797 Penrith South DC
NSW 1797
Country 12370 0
Australia
Phone 12370 0
+61 2 46203777
Fax 12370 0
+61 2 46203291
Email 12370 0
[email protected]
Contact person for scientific queries
Name 3298 0
Associate Professor Caroline Smith
Address 3298 0
Centre for Complementary Research
Locked Bag 1797 Penrith South DC
NSW 1797
Country 3298 0
Australia
Phone 3298 0
+61 2 46203777
Fax 3298 0
+61 2 46203291
Email 3298 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
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Documents added automatically
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