Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000923268
Ethics application status
Approved
Date submitted
26/10/2009
Date registered
27/10/2009
Date last updated
28/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Acupuncture and reproductive health outcomes: building evidence in an integrated care setting.
Scientific title
A pilot study to examine evidence of an immune response from acupuncture when administered to women undergoing a fresh in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle on the day of an embryo transfer
Secondary ID [1] 252337 0
Does acupuncture stimulate an mmune response?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reproductive Health 252036 0
Immune System Health 252038 0
Condition category
Condition code
Reproductive Health and Childbirth 252224 252224 0 0
Fertility including in vitro fertilisation
Inflammatory and Immune System 252225 252225 0 0
Normal development and function of the immune system
Alternative and Complementary Medicine 252226 252226 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will seek two groups of women to parctipate in the research, women using acupuncture and a group not receiving acupuncture.
The acupuncture group will require women to attend for acupuncture on the day of an embryo transfer (ET). Two acupuncture treatments will be administered for 25 minutes on the day of ET, immediately before and after ET. The acupuncture is based on the Paulus protocol and include an initial set of ten acupuncture points, and four auricular points.

The control group receives standard care only.
Intervention code [1] 241433 0
Treatment: Other
Comparator / control treatment
No treatment will be administered.
Control group
Active

Outcomes
Primary outcome [1] 253098 0
Immune modulation as measured by serum tumor necrosis factor (TNF) alpha, interleukin-6, interleukin-10, interferon-gamma (IFNg), and natural killer cells
Timepoint [1] 253098 0
The day befor embryo transfer and the day following ET.
Secondary outcome [1] 257962 0
Reduced anxiety as measured by the Speilberger Stait Trait Inventory
Timepoint [1] 257962 0
The day prior to embryo transfer and the day following ET.
Secondary outcome [2] 257963 0
Adverse effects and evaluation of acceptability. Adverse effects may include nausea, dizziness, fainting, increased pain or bruising. Both adverse effects and evaluation of acceptability will be assessed by self reporting using a questionnaire.
Timepoint [2] 257963 0
The day following ET.

Eligibility
Key inclusion criteria
Women aged less than 43 years, undergoing a fresh IVF or ICSI cycle, with two unsuccessful ETs (includes previous cleavage or blastocyst stage transfers (fresh or frozen), of quality embryos deemed by the embryologist to have been suitable for freezing by standard criteria), and undergoing a stimulated cycle.
Minimum age
18 Years
Maximum age
42 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women undergoing a frozen ET, women less than 18 years, previous acupuncture during this IVF cycle, planning pre-implantation genetic diagnosis, or receiving donor eggs.

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)
For women receiving acupuncture initial contact will be made via the Acupuncture IVF support website and via the telephone through referrals.

Volunteers will be sought from patients of the study investigators to participate in the control group. Women willing to volunteer will be asked to contact the acupuncture clinic directly for further information.

The research acupuncturist will be responsible for taking consent and entering women into the study,
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243904 0
Other Collaborative groups
Name [1] 243904 0
National Institute of Complementary Medicine
Country [1] 243904 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bag 1797
SOUTH PENRITH DC
NSW 1797
Country
Australia
Secondary sponsor category [1] 251248 0
University
Name [1] 251248 0
Centre for Complementary Medicine Research
Address [1] 251248 0
University of Western Sydney
Bldg 5 Campbelltown Campus
Locked Bag 1797
SOUTH PENRITH DC
NSW1797
Country [1] 251248 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244019 0
IVF Australia Ethics Committee
Ethics committee address [1] 244019 0
IVF Australia Head Office
Level 1, 33 York St
Sydney NSW 2000
Ethics committee country [1] 244019 0
Australia
Date submitted for ethics approval [1] 244019 0
26/10/2009
Approval date [1] 244019 0
Ethics approval number [1] 244019 0
EC00346

Summary
Brief summary
There is promising evidence that acupuncture improves pregnancy and live birth rates for women when administered as an adjunct to IVF on the day of ET.

The aim of this study is to build a research framework to further investigate the evidence for acupuncture administered within an integrated care setting in reproductive health care. The integrative care proposal is a partnership between IVF Australia, The Acupuncture IVF Support Clinic and The University of Western Sydney.

We will conduct early phase research to examine a potential mechanism for acupuncture when administered as an adjunct to IVF.
Trial website
Trial related presentations / publications
Presentation will be made at conferences and a manuscript prepared for publication.
Public notes

Contacts
Principal investigator
Name 30401 0
Address 30401 0
Country 30401 0
Phone 30401 0
Fax 30401 0
Email 30401 0
Contact person for public queries
Name 13648 0
Dr Caroline Smith
Address 13648 0
Centre for Complementary Medicine Research
University of Western Sydney
Building 5, Campbelltown Campus
Locked Bag 1797
SOUTH PENRITH DC
NSW 1797
Country 13648 0
Australia
Phone 13648 0
+61 2 46203777
Fax 13648 0
+61 2 46203291
Email 13648 0
caroline.smith@uws.edu.au
Contact person for scientific queries
Name 4576 0
Dr Caroline Smith
Address 4576 0
Centre for Complementary Medicine Research
University of Western Sydney
Building 5, Campbelltown Campus
Locked Bag 1797
SOUTH PENRITH DC
NSW 1797
Country 4576 0
Australia
Phone 4576 0
+61 2 46203777
Fax 4576 0
+61 2 46203291
Email 4576 0
caroline.smith@uws.edu.au

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.