Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000288224
Ethics application status
Approved
Date submitted
2/03/2009
Date registered
18/05/2009
Date last updated
8/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of acupuncture on psychosocial outcome for women experiencing infertility
Scientific title
A pilot pragmatic randomised controlled trial of acupuncture on psychosocial outcome for women experiencing infertility.
Secondary ID [1] 252176 0
Acupuncture for stress and anxiety associated with infertility
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility
Mental health 4402 0
Mental Health 4404 0
Condition category
Condition code
Mental Health 4653 4653 0 0
Other mental health disorders
Alternative and Complementary Medicine 4657 4657 0 0
Other alternative and complementary medicine
Reproductive Health and Childbirth 4990 4990 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupuncture which will follow a protocol that will involve a traditional acupuncture diagnostic assessment. The treatment plan will incorporate the five element acupuncture points focussing on emotional well being. Acupuncture will be applied bilaterally, needles will be inserted to tissue level and stimulated manually to elicit the 'de qi' response. Acupuncture needles may be inserted in arms, legs and/or chest region. A total of six treatments of 40 minutes duration will be administered approximately every week and a half over a two month period.
Intervention code [1] 4135 0
Treatment: Other
Comparator / control treatment
No treatment: Wait list control. The control group will be offered treatment after the 2 month intervention period.
Control group
Active

Outcomes
Primary outcome [1] 5521 0
Infertility self efficacy measured by the infertility self efficacy scale
Timepoint [1] 5521 0
Trial entry and at two months after intervention commencement
Secondary outcome [1] 9292 0
Infertility related stress measured by the fertility problem inventory.
Timepoint [1] 9292 0
Trial entry and at two months after intervention commencement
Secondary outcome [2] 9293 0
Anxiety as measured by state trait anxiety
Timepoint [2] 9293 0
Trial entry and at two months after intervention commencement
Secondary outcome [3] 9294 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 [3] 9294 0
Two months after intervention commencement

Eligibility
Key inclusion criteria
Women with a diagnosis of infertility and/or history of unsuccessfully trying to conceive for 12 months or more.
The ability to read and write english.
Ability to provide informed written consent.
Minimum age
20 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current involvement in a professionally led infertility support group or workshop planned in the next two months, planning to use acupuncture in the next four months

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)
Allocation was concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation in balanced, variable blocks, prepared by a researcher not involved in the trial. The sequence generated using computer software. Women will be allocated to a study group by taking the next sequentially numbered sealed opaque envelope.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Wait list control. Women assigned to the wait list control condition will complete all assessments but will not achieve any active intervention during the 2 month trial. They will be offered acupuncture after this time period.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4582 0
University
Name [1] 4582 0
University of Western Sydney
Country [1] 4582 0
Australia
Primary sponsor type
University
Name
Centre for Complementary Medicine Research (CompleMED), University of Western Sydney
Address
Locked Bag 1797
Penrith Sth DC
NSW 1797
Country
Australia
Secondary sponsor category [1] 4131 0
None
Name [1] 4131 0
Address [1] 4131 0
Country [1] 4131 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6629 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 6629 0
University of Western Sydney
Locked Bag 1797
Penrith Sth DC
NSW 1797
Ethics committee country [1] 6629 0
Australia
Date submitted for ethics approval [1] 6629 0
Approval date [1] 6629 0
25/02/2009
Ethics approval number [1] 6629 0
H6697

Summary
Brief summary
Infertility can lead to emotional distress which may place some people at risk of developing a mental health problem. The use of complimentary and alternative therapies are growing in popularity and there is some evidence that acupuncture may increase pregnancy rates in women undergoing In Vitro Fertilisation (IVF). Research findings suggest acupuncture given to women when trying to get pregnant may also lead to an improvement in their emotional well being, and that women may cope better with their IVF treatment. We propose to undertake a pilot randomised controlled trial of acupuncture to explore these effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29336 0
Address 29336 0
Country 29336 0
Phone 29336 0
Fax 29336 0
Email 29336 0
Contact person for public queries
Name 12583 0
Dr Caroline Smith
Address 12583 0
CompleMED
University of Western Sydney
Locked Bag 1797
Penrith Sth DC
NSW 1797
Country 12583 0
Australia
Phone 12583 0
+61 2 46203777
Fax 12583 0
Email 12583 0
[email protected]
Contact person for scientific queries
Name 3511 0
Dr Caroline Smith
Address 3511 0
CompleMED
University of Western Sydney
Locked Bag 1797
Penrith Sth DC
NSW 1797
Country 3511 0
Australia
Phone 3511 0
+61 2 46203777
Fax 3511 0
Email 3511 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.