Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000226909
Ethics application status
Approved
Date submitted
1/03/2011
Date registered
2/03/2011
Date last updated
7/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Acupuncture to improve live births for women undergoing IVF: a randomised controlled trial
Scientific title
Acupuncture compared to sham acupuncture and standard care to improve live birth rates for women undergoing IVF: a randomised
controlled trial
Secondary ID [1] 259700 0
Nil
Universal Trial Number (UTN)
U1111-1119-6770
Trial acronym
ACU_ART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 261275 0
Condition category
Condition code
Reproductive Health and Childbirth 259425 259425 0 0
Fertility including in vitro fertilisation
Alternative and Complementary Medicine 259443 259443 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupuncture will be administered on day 6-8 of the IVF cycle. The scheduling of this single appointment will be based on their scheduled visit to the IVF Centre. This treatment will take one hour. In addition, two treatments will be given on the day of the embryo transfer. The duration of these two treatments will be 30 minutes respectively, and will take place immediately before and after the embryo transfer.

The first treatment will be individualised based on their TCM diagnosis, plus core points Stomach 29, Conception vessel 4, Conception vessel 6, Spleen 6, Spleen 10.These points were selected from a consensus process undertaken with international experts.

The points administered on the day of the embryo transfer include: CV4, ST29, LR3, SP8, SP10 and one of the following (Yintang, PC6, HT7), GV20, KD3, ST36, SP6, PC6.
Intervention code [1] 264129 0
Treatment: Other
Comparator / control treatment
Study group 2: The sham acupuncture group will use the Park Sham device which has a guide tube making it impossible for the subject to see whether the needle has penetrated the skin or not. The sham needle its self is able to slide into the handle, which increases the appearance that the skin has been penetrated. Needle penetration does not occur. The sham needle will be placed away from acupuncture points. The sham acupuncture device is an effective masking device for blinding in randomised controlled trials of acupuncture. Treatment will be administered on day 6-8 and twice on the day of an embryo trasnfer. Study Group 3: Standard care. Standard care involves use of the usual pharmacological and surgical protocols used during the IVF cycle. This is a non randomised arm and women will contribute data only. The trial co-ordinator will make contact with subjects at the assessment time.
Control group
Placebo

Outcomes
Primary outcome [1] 262244 0
Live birth. Defined as the delivery of one or more living infants, greater than 20 weeks gestation or 400grams or more birth weight.
Timepoint [1] 262244 0
At the time of the delivery of baby.
Secondary outcome [1] 273380 0
1. clinical pregnancy defined as demonstration of fetal heart activity on ultrasound scan.
Timepoint [1] 273380 0
1. Clinical pregnancy measured at 7-8 weeks from the start of the IVF cycle.
Secondary outcome [2] 273381 0
2. Miscarriage defined as a non viable pregnancy prior to 12 weeks gestation.
Timepoint [2] 273381 0
Miscarriage defined as a non viable pregnancy prior to 12 weeks.
Secondary outcome [3] 273388 0
3. Quality of life
Timepoint [3] 273388 0
Measured at trial entry, two and 14 weeks from trial entry using the SF36.
Secondary outcome [4] 273389 0
4. Self efficacy
Timepoint [4] 273389 0
Measured at trial entry, two and 14 weeks from trial entry, using the infertility self efficacy scale.

Eligibility
Key inclusion criteria
Women aged less than 43 years, undergoing a fresh IVF or ICSI cycle.
Minimum age
18 Years
Maximum age
42 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women undergoing a frozen ET, previous randomisation to this trial, planning pre-implantation genetic diagnosis, or receiving donor eggs, or having current acupuncture use.

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)
Research nurses will provide women with information on the trial. Trial entry and randomisation will be done prior to day 6-8 of the the IVF cycle. Randomisation will be undertaken centrally through a phone randomisation service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Women will be allocated to a study group by a phone randomisation service, prepared and based at the NHMRC Clinical Trials Centre. There will be stratification by number of ET cycles (0-1, 2-6 and 6+), woman’s age (<38, and 38-42 years), and collaborating centre.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2011
Actual
29/06/2011
Date of last participant enrolment
Anticipated
23/10/2015
Actual
23/10/2015
Date of last data collection
Anticipated
Actual
9/09/2016
Sample size
Target
921
Accrual to date
Final
847
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment postcode(s) [1] 3730 0
5000
Recruitment postcode(s) [2] 3731 0
2035
Recruitment postcode(s) [3] 3732 0
4120
Recruitment postcode(s) [4] 7311 0
5042 - Bedford Park
Recruitment postcode(s) [5] 7312 0
3002 - East Melbourne
Recruitment postcode(s) [6] 7313 0
2640 - Albury
Recruitment postcode(s) [7] 7314 0
2145 - Westmead
Recruitment outside Australia
Country [1] 3245 0
New Zealand
State/province [1] 3245 0
North Island

Funding & Sponsors
Funding source category [1] 264592 0
Government body
Name [1] 264592 0
National Health and Medical Research Council
Country [1] 264592 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Centre for Complementary Medicine Research
University of Western Sydney
Locked Bag 1797
Pentrith South DC
NSW 2751
Country
Australia
Secondary sponsor category [1] 263732 0
None
Name [1] 263732 0
Address [1] 263732 0
Country [1] 263732 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260584 0
University of Western Sydney
Ethics committee address [1] 260584 0
Ethics committee country [1] 260584 0
Australia
Date submitted for ethics approval [1] 260584 0
14/02/2011
Approval date [1] 260584 0
23/03/2011
Ethics approval number [1] 260584 0
H8936

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

Contacts
Principal investigator
Name 32287 0
Prof Caroline Smith
Address 32287 0
Centre for Complementary Medicine Research University of Western Sydney Locked Bag 1797 Penrith South DC NSW 2751
Country 32287 0
Australia
Phone 32287 0
+61 2 4620 3777
Fax 32287 0
Email 32287 0
[email protected]
Contact person for public queries
Name 15534 0
Caroline Smith
Address 15534 0
Centre for Complementary Medicine Research
University of Western Sydney
Locked Bag 1797
Penrith South DC
NSW 2751
Country 15534 0
Australia
Phone 15534 0
+61 2 4620 3777
Fax 15534 0
+61 2 4620 3291
Email 15534 0
[email protected]
Contact person for scientific queries
Name 6462 0
Caroline Smith
Address 6462 0
Centre for Complementary Medicine Research
University of Western Sydney
Locked Bag 1797
Penrith South DC
NSW 2751
Country 6462 0
Australia
Phone 6462 0
+61 2 4620 3777
Fax 6462 0
+61 2 4620 3291
Email 6462 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
SourceTitleYear of PublicationDOI
EmbaseAcupuncture and assisted reproductive technology.2013https://dx.doi.org/10.1002/14651858.CD006920.pub3
EmbaseEffect of acupuncture VS sham acupuncture on live births among women undergoing in vitro fertilization a randomized clinical trial.2018https://dx.doi.org/10.1001/jama.2018.5336
N.B. These documents automatically identified may not have been verified by the study sponsor.